Hearing Loss Treatment Report

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SENS-401 Phase 2 trial results expected in mid-2021, prelinical data expected by end of 2020

https://www.businesswire.com/news/home/20201020006234/en/Sensorion-reports-2020-first-half-results

Preclinical data from these studies are expected by the end of 2020.

Sensorion reports 2020 first half results
Financial position strengthened with €31m (US$36.5m) capital raise in September 2020

Gene therapy agreement expands pipeline and preclinical data
SENS-401 Phase II trial progressing with results expected in mid-2021
Cash position of €30.7m as of June 30, 2020, further reinforced by September capital raise
Cash runway now extended to H2 2022

Estimated FX-322 Phase 2a Study Completion Date: May 21, 2021

Very quick update:

The FX-322 Phase 2a clinical trial is now *officially* active and we now have an updated estimated completion date for the study: May 21, 2021.

Details below:

  • The FX-322 study record was updated on October 8, 2020
  • The study status was changed from “Recruiting” to “Active, not recruiting”
  • The study completion date was changed from September 30, 2020 [Anticipated] to May 21, 2021 [Anticipated].

FX-322 trial update October 8, 2020 now active

Source: History of Changes for Study: NCT04120116 (FX-322 in Adults With Stable Sensorineural Hearing Loss)

That’s all for now.

For the latest FX-322 updates and news of other hearing loss treatments, sign up for the free once-weekly email newsletter.

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How much will FX-322 cost? David Lucchino, Frequency Therapeutics CEO, talks pricing and value…

How much will FX-322 cost?

David Lucchino, CEO of Frequency Therapeutics, was recently asked for some “rough ideas around [the] pricing and reimbursement” of FX-322.

Here is a lightly edited* almost-word-for-word transcript of David’s response**:

*EDITED HOW? Disconnected parts of speech and filler words such as umm, well, you know, etc., have been removed for sake of clarity.

**SPOILER ALERT: David, understandably, does NOT give us a specific number. He gives us the answer we all expected, that of a responsible CEO. As he says, “specifics around pricing and regulatory ‘really need to be managed and played out appropriately'” (in other words, NOT eagerly telling us “FX-322 WILL COST EXACTLY THESE MANY DOLLARS” while the drug is still in phase 2a clinical trials).

Alas.

Specifics? Best I can do is this:

HOST: […] walk us through your thinking around the target patient population and maybe some kind of rough ideas around pricing and reimbursement […]

DAVID LUCCHINO: I’m still evolving our understanding of this as we really work in partner with the FDA to understand exactly the true, we think, impact of our therapy. So it’s hard for me to speak in any absolutes. We know that the market is absolutely substantial and the unmet clinical need is very, very high. We think that hearing aids will continue to have a real role and be a good option for patients, though we think having a therapy that can truly start to heal someone’s hearing and create a healthy cochlea, if you will, is going to be a very strong value proposition both with or without hearing aids. I think that specifics around pricing and regulatory, those really need to be managed and played out appropriately. I think that we’re aware of what hearing aids are priced at, and we’re aware of what cochlear implants are priced at, and how hearing aids are handled from a regulatory standpoint and our goal is to deliver a highly effective therapy and do it in a way where we can continue to build out a very successful company that investors will recognize for years and years to come.

HOST: Excellent, super helpful.

SOURCE: Where is this from? These comments were made during a live Q&A at the Oppenheimer Virtual Fall Healthcare Life Sciences & MedTech Summit, which took place on Tuesday, September 22, 2020 at 10:00 am Eastern Time.

As David’s comments suggest, a lot of work goes into determining the price of a treatment such as FX-322. Meanwhile, the drug only recently completed enrollment for its Phase 2a study.

So don’t expect any “Hey it will cost THIS many dollars” answers yet…

For now, this recent commentary is the most recent and up-to-date information regarding FX-322’s price tag. Straight from the CEO’s mouth.

And let’s be honest, it is the reply we all expected… But with some interesting “price anchoring” thrown in with the mention of hearing aid costs (average price: $2372) and cochlear implant costs (average price: between $30,000-$100,000).***

Why would David mention those price points? How do drug companies calculate price? How do comparisons and price anchoring factor into that calculation?

Hmmmm…

Let the speculation begin!

Excellent Super Helpful vague troll face meme

LINK TO VIDEO: If you want to watch the interview, here is a link to the video recording of the Frequency Therapeutics virtual event webcast (the FX-322 pricing-related comments begin at around 39:00):

https://wsw.com/webcast/oppenheimer5/freq/2713518

And…

If you want an easy way to follow FX-322 including any future updates RE: cost of FX-322, join the weekly email update list. It’s a free, once-weekly email [starting soon] that lists all the new links that were added to this site’s front page during the previous 7 days. No spam, no nonsense.

***Reference: https://www.hearingtracker.com/how-much-do-hearing-aids-cost, https://www.hearingtracker.com/cochlear-implants#a-how-much-do-cochlear-implants-cost.

Frequency Therapeutics Presents Results Demonstrating Sustained Improvement in Hearing Loss Patients Treated with FX-322

https://investors.frequencytx.com/news-releases/news-release-details/frequency-therapeutics-presents-results-demonstrating-sustained

Frequency Therapeutics Presents Results Demonstrating Sustained Improvement in Hearing Loss Patients Treated with FX-322

Evidence of Durable Hearing Improvements in Follow-Up with Patients from Phase 1/2 Study; Speech Intelligibility and Audibility Sustained for Up to 21 Months After Initial Dosing

Data Highlighted at the 2020 American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) Annual Meeting

Role of protein in development of new hearing hair cells: Finding could lead to future treatments for hearing loss

https://www.sciencedaily.com/releases/2020/09/200911200012.htm

Role of protein in development of new hearing hair cells
Finding could lead to future treatments for hearing loss

Date:
September 11, 2020

Source:
University of Maryland School of Medicine

Summary:
Researchers have conducted a study that has determined the role that a critical protein plays in the development of hair cells. These hair cells are vital for hearing. Some of these cells amplify sounds that come into the ear, and others transform sound waves into electrical signals that travel to the brain.

Frequency Therapeutics Expects to Share FX-322 Phase 2a Study Results in Q2 2021

https://www.businesswire.com/news/home/20200812005136/en/

expects to achieve target enrollment by early in the fourth quarter of 2020. Based on this timeline, the Company expects to report study data in the second quarter of 2021.

Frequency Therapeutics Provides Business Updates and Reports Second Quarter 2020 Financial Results
Expects to Complete Enrollment of FX-322 Phase 2a Study for Sensorineural Hearing Loss by Early Q4 2020; Study Readout Anticipated in Q2 2021

Recently Announced Clinical Data Show FX-322 Delivery to the Cochlea and Preliminary Evidence of a Durable Clinical Benefit; Plans New Studies in Additional Patient Populations

Raised $42.3 Million Private Placement, Providing Company Runway into 2023

August 12, 2020 07:30 AM Eastern Daylight Time
WOBURN, Mass.–(BUSINESS WIRE)–Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage biotechnology company focused on harnessing the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced business updates and financial results for the second quarter ended June 30, 2020.

“We are pleased with the steady progress in our Phase 2a study, despite the challenges of the pandemic, and we anticipate completing enrollment early in the fourth quarter of 2020 and sharing data from the study in the second quarter of 2021,” said Frequency Therapeutics Chief Executive Officer David L. Lucchino. “In the last quarter, we generated compelling cochlear drug delivery data for FX-322, as well as important durability data suggesting that some patients who were given a single injection of FX-322 in our original Phase 1/2 study maintained statistically significant improvements in word recognition between 12 and 21 months following administration. We believe that these clinical advances are important building blocks as we work to further our understanding of FX-322 drug activity and the patient populations we hope to treat.

PIPE-505 Clinical Trial Update: Pipeline adds 4 new study locations across the United States…

As anticipated, Pipeline Therapeutics has added additional clinical trial sites to its phase 1/2a study of PIPE-505 for hearing loss.

The official study record (NCT04462198), updated on August 6, 2020, now includes five study locations across the U.S., four of which are now recruiting participants:

  • Boca Raton, Florida, United States, 33487 – added July 17 – Recruiting
  • Winston-Salem, North Carolina, United States, 27103 – added July 27 – Recruiting
  • New Albany, Indiana, United States, 47150 – added August 1 – Recruiting
  • Louisville, Kentucky, United States, 40220 – added August 1 – Recruiting
  • Kansas City, Kansas, United States, 66160 – added August 4 – Not yet recruiting

This post will be updated to include any further changes to the study record. For email updates (which will be starting soon), join the announcement list while it is still open.

Pipeline Therapeutics Initiates Phase 1/2a Clinical Trial of PIPE-505 in Sensorineural Hearing Loss – Topline results expected in early 2021…

https://www.pipelinetherapeutics.com/news/pr_07-23-2020.php

Pipeline Therapeutics Initiates Phase 1/2a Clinical Trial of PIPE-505 in Sensorineural Hearing Loss
PIPE-505 is the first small molecule developed specifically for the treatment of sensorineural hearing loss (SNHL) associated with speech-in-noise impairment
Topline results expected in early 2021
SAN DIEGO, July 23, 2020 – Pipeline Therapeutics, a biopharmaceutical company focused on the development and commercialization of first-in-class small molecules for neuroregeneration, today announced the initiation of a Phase 1/2a trial of the company’s lead product candidate, PIPE-505, a small molecule gamma secretase inhibitor (GSI), in sensorineural hearing loss (SNHL) associated with hearing speech in noisy environments.

UPDATE: Pipeline Therapeutics Begins Recruiting Patients for Phase 1/2a Study of PIPE-505 for SNHL

This is a follow-up post to the previous PIPE-505 clinical trial update from July 8 where we explained how “patient recruitment could begin any day now.”

Today, less than two weeks later, that forecast proved accurate: the PIPE-505 trial is now RECRUITING, according to the official study record (NCT04462198), which had its Recruitment Status updated yesterday.

Here is an excerpt from that ClinicalTrials.gov record:

STUDY TITLE: A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Unilateral Intratympanic PIPE-505 in Subjects With Sensorineural Hearing Loss Associated With Speech-in-Noise Impairment

Recruitment Status: Recruiting
First Posted: July 8, 2020
Last Update Posted: July 20, 2020

DESCRIPTION: This is a randomized-controlled, double-blind study of PIPE-505 or placebo given as an injection one time in subjects with sensorineural hearing loss associated with speech-in-noise difficulty. Visits to the clinic will occur at baseline, dosing, and days 1, 7, 14, 30, 60 and 90 after treatment. Safety will be assessed by periodic measurement of vital signs, ear examination, electrocardiogram (ECG), blood laboratory analyses and occurrence of adverse events (AE). Efficacy will be assessed by periodic audiometry and other audiological tests.

ClinicalTrials.gov Identifier: NCT04462198

Where is the PIPE-505 study located?

As of July 21, 2020, there is only one recruitment location (Florida) for the trial. But it is common for studies like this one to expand and add more locations across the country and sometimes internationally, too. We expect more recruitment sites to be added in the next 4-6 weeks, although we do not have an exact list of those locations… yet…

UPDATE: August 29, 2020 – A second recruitment location (North Carolina) has been added to the list. (More to come?)

More updates to follow for PIPE-505 and other up-and-coming hearing loss treatments. Keep an eye on the front page of this website for updates, or get email updates (it’s an upcoming once-weekly email newsletter – no spam, no third parties, privacy respected).

People on the email list will get first access to new versions of this website that track more research from more sources…

Questions? Comments? Corrections? Collaborations? Send an email to michael@urgentresearch.com and say hello.

Pipeline Therapeutics Initiates Phase 1/2 Clinical Trial of PIPE-505 for Sensorineural Hearing Loss

The study titled, Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss, was added to the official ClinicalTrials.gov databased on July 8, 2020.

The recruitment status of the clinical trial is currently set to “Not yet recruiting.” However, that could change very soon, considering a) the follow-up period for trial participants after the initial drug administration lasts 3 months, and b) the anticipated primary completion date of the study is four months away, in November 2020.

These details suggest that patient recruitment could begin any day now and – assuming there are no changes to the study’s current schedule – probably no later than 4-6 weeks from now.

UPDATE (current as of July 21, 2020): the PIPE-505 study is now recruiting patients… see this follow-up post for details or visit the official study page using the link below:

https://clinicaltrials.gov/ct2/show/NCT04462198

Here is further reading about PIPE-505, a small molecule gamma secretase inhibitor (GSI) that will be delivered to select trial participants as a one-time intratympanic injection:

PIPE-505 is the first small molecule developed specifically for the treatment of sensorineural hearing loss (SNHL) associated with cochlear synaptopathy. The therapeutic focus, regeneration of the cochlear synapse, should augment signal-to-noise processing and manifest as improved speech-in-noise comprehension, a chief auditory complaint and unmet need of patients with SNHL.

Source: https://www.pipelinetherapeutics.com/science/synaptogenesis.html

A simpler way to make sensory hearing cells

https://www.sciencedaily.com/releases/2020/07/200701134242.htm

A simpler way to make sensory hearing cells
Date:
July 1, 2020
Source:
Keck School of Medicine of USC
Summary:
Scientists are whispering the secrets of a simpler way to generate the sensory cells of the inner ear. Their approach uses direct reprogramming to produce sensory cells known as ‘hair cells,’ due to their hair-like protrusions that sense sound waves.

Otonomy Provides Update on OTO-413 Clinical Trial: Results from Phase 1/2 study of OTO-413 for hearing loss expected in fourth quarter of 2020

https://www.globenewswire.com/news-release/2020/06/15/2048357/0/en/Otonomy-Provides-Update-on-Clinical-Trials-and-Development-Programs.html

Otonomy Provides Update on Clinical Trials and Development Programs

June 15, 2020 16:05 ET | Source: Otonomy, Inc.

  • Results from Phase 3 trial of OTIVIDEX® in Ménière’s disease expected in first quarter of 2021
  • Results from Phase 1/2 trial of OTO-313 in tinnitus expected in July 2020
  • Results from Phase 1/2 trial of OTO-413 in hearing loss expected in fourth quarter of 2020

SAN DIEGO, June 15, 2020 (GLOBE NEWSWIRE) — Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided an update on its product pipeline and the timeline to results for the company’s three ongoing clinical trials, including the Phase 3 trial of OTIVIDEX in Ménière’s disease. The company will host a conference call and webcast today at 4:30 p.m. ET to review these updates.

NO COVID-19 SLOWDOWN: Frequency Therapeutics Adds Another Recruitment Site for FX-322 Phase 2a Study

Frequency Therapeutics has once again updated the official Study Record of its Phase 2a clinical trial of FX-322 in Adults With Stable Sensorineural Hearing Loss.

The update – which includes a new clinical trial site in Austin, Texas – was posted to ClinicalTrials.gov on April 10, 2020.

No Slowdown Due to COVID-19?

It looks like the FX-322 trial is still moving forward as expected, running on schedule.

Usually, a small change to a study record would not seem like such big news.

However, in the context of COVID-19, it is noteworthy. And uplifting! Why?

Consider this: while many clinical trials across the world are experiencing massive slowdowns and stoppages due to COVID-19, the FX-322 Phase 2a trial is expanding its presence to yet another location in the United States. Expanding!

That is not to say the trial has not been affected by COVID-19. For example, patient recruitment efforts and other logistics have probably become more challenging.

However, despite all that is happening, what we see with this update is more activity and signs of life. Things are happening. Plus, we have proof that the study is not paused or stopped. In fact, there is no sign of any delay at all…

FULL SPEED AHEAD!

The estimated study completion date (September 30, 2020) remains unchanged. Repeat: the estimated completion date of the FX-322 trial has NOT been pushed back despite the impact of COVID-19, according to the latest study record.

Small update, big news.

Link to official study page:

https://clinicaltrials.gov/ct2/show/NCT04120116

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Strekin AG Completes Phase 3 Clinical Study of STR001 to Restore Hearing in Patients with SSNHL

Strekin AG, a Swiss-based biopharmaceutical company focused on developing new treatments to reverse hearing loss, has completed its Phase 3 clinical trial of the investigational drug STR001 in patients with Sudden Sensorineural Hearing Loss (SSNHL).

According to the official study record (Source: ClinicalTrials.gov), the Status of Study NCT03331627, Safety and Efficacy of STR001-IT and STR001-ER in Patients With SSHL, was changed from “Recruiting” to “Completed” on March 25, 2020. The actual completion date of the study was updated to February 6, 2020.

The purpose of this international, randomized, placebo-controlled, Phase 3 study, officially titled Phase III Multicenter, Double-blind, Placebo-controlled, Study Evaluating the Safety, and Efficacy of STR001 Treatment in Adults With Sudden Sensorineural Hearing Loss, was to evaluate the ability of STR001 to restore hearing in patients following a SSNHL event.

If the results are promising, STR001 could become the first approved treatment for SSNHL patients.

The previous update related to this clinical trial of STR001 was from over six months ago, on September 12, 2019. That is when Strekin AG announced in a press release the completion of patient recruitment for the study (which involved 165 patients).

Prior to that, the last change to the study record was almost a year ago, on April 10, 2019. That is when the study began recruiting patients, according to the official study page.

Source:

https://clinicaltrials.gov/ct2/show/NCT03331627?type=Intr

To get more exclusive (and early, early, early) hearing loss treatment-related news and updates, remember to join the mailing list for HearingLossTreatmentReport.com Email Updates. It’s free and you can unsubscribe at any time. One email per week – a simple list of links that were posted on the site during the previous 7 days. No spam or nonsense, completely private.

INVITATION TO RESEARCHERS, INDUSTRY PROFESSIONALS, and RESEARCH-SEEKING PATIENTS: For more information about how this site works, and how it automatically gathers all the latest and most relevant hearing loss treatment-related updates non-stop, 24/7… send an email to michael@urgentresearch.com and say hello.
– Michael S.

P.S. Here are three other hearing-related “treatment report” sites that might interest you:

COMPLETED: Novartis Phase 1/2 Trial of CGF166, an Inner Ear Gene Therapy for Hearing Loss

The status of study NCT02132130 (Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss), was changed from “Active, not recruiting” to “Completed” on March 19, 2020.

According to the official study record, the actual completion date of the trial was December 9, 2019.

The previous update to this clinical trial of CGF166 was posted just over four months ago, on November 15, 2019. That is when the study status was changed from “Recruiting” to “Active, not recruiting.”

Source:
https://clinicaltrials.gov/ct2/show/NCT02132130

Discovery of a pharmacological treatment that could “wake up” the human body’s ability to naturally regenerate lost hair cells and reverse hearing loss

Many fish, frogs, and birds possess special regeneration capacities that allow them to fully recover from hearing impairments and balance dysfunctions caused by lost hair cells.

Humans and other mammals, however, do NOT have this ability.

Sadly, our mammalian ears are vulnerable to permanent hearing loss and balance deficits.

But that could soon change…

Because new research from Jeff T. Corwin at the University of Virginia appears to have uncovered the reason for the permanent nature of hair cell loss in humans. The findings identify why certain creatures can recover from hearing damage and why humans cannot.

The most exciting part?

The team behind the research, part of Corwin’s Laboratory of Inner Ear Sensory Hair Cell Regeneration, has discovered a pharmacological treatment that could “wake up” the special supporting cells that can allow lost hair cells to regenerate in humans.

To learn more about how it works, here is a link to the study itself — which was published on February 20, 2020 in the Journal of Neuroscience.

EGF and a GSK3 Inhibitor Deplete Junctional E-cadherin and Stimulate Proliferation in the Mature Mammalian Ear.

Here is the abstract:

J Neurosci. 2020 Feb 19;:
Authors: Kozlowski MM, Rudolf MA, Corwin JT

Sensory hair cell losses underlie the vast majority of permanent hearing and balance deficits in humans, but many non-mammalian vertebrates can fully recover from hearing impairments and balance dysfunctions, because supporting cells (SCs) in their ears retain lifelong regenerative capacities that depend on proliferation and differentiation as replacement hair cells. Most SCs in vertebrate ears stop dividing during embryogenesis, and soon after birth vestibular SCs in mammals transition to lasting quiescence as they develop massively thickened circumferential F-actin bands at their E-cadherin-rich adherens junctions.

Here, we report that treatment with EGF and a GSK3 inhibitor thinned the circumferential F-actin bands throughout the sensory epithelium of cultured utricles that were isolated from adult mice of either sex. That treatment also caused decreases in E-cadherin, β-catenin, and YAP in the striola, and stimulated robust proliferation of mature, normally quiescent striolar SCs. The findings suggest that E-cadherin-rich junctions, which are not present in the SCs of the fish, amphibians, and birds which readily regenerate hair cells, are responsible in part for the mammalian ear’s vulnerability to permanent balance and hearing deficits.

SIGNIFICANCE STATEMENT

Millions of people are affected by hearing and balance deficits that arise when loud sounds, ototoxic drugs, infections, and aging cause hair cell losses. Such deficits are permanent for humans and other mammals, but non-mammals can recover hearing and balance after supporting cells regenerate replacement hair cells. Mammalian supporting cells lose the capacity to proliferate around the time they develop unique, exceptionally reinforced, E-cadherin-rich intercellular junctions. Here, we report the discovery of a pharmacological treatment that thins F-actin bands, depletes E-cadherin, and stimulates proliferation in long-quiescent supporting cells within a balance epithelium from adult mice. The findings suggest that high E-cadherin in those supporting cell junctions may be responsible, in part, for the permanence of hair cell loss in mammals.

PMID: 32079647 [PubMed – as supplied by publisher]

Additional research shows that there is a U.S. Provisional Patent Application related to the research posted here is currently pending. The application number is 62/951,996 and it was filed on December 20, 2019. The patent applicant is Jeffrey T. Corwin, and the other inventors listed include Mark Rudolf and Mikolaj Kozlowski.

Hearing Loss Treatment Report will continue to keep an eye on this promising new (potential) hearing loss treatment, which involves treatment with an EGF and a GSK3 inhibitor, and is currently being tested in mice. But considering the patent filing and strong evidence, human trials will surely follow.

Want updates? Remember to sign up for free weekly email updates, here. Especially if you want to know about new hearing loss drugs and experimental treatments as soon as possible.

Questions? Comments? Corrections? Feedback?

Send an email to michael@urgentresearch.com and say hello. This site is almost completely automated (except for occasional “exclusive” articles like this one), but there is a human behind the scenes.

FX-322 Phase 2a Clinical Trial Update: 4 new recruitment sites… plus, changes to eligibility criteria…

Frequency Therapeutics updates official Study Record of Phase 2a clinical trial, FX-322 in Adults With Stable Sensorineural Hearing Loss.

The changes were posted to ClinicalTrials.gov on January 29, 2020 and involve: a) four new study locations, and b) adjustments to the eligibility criteria.

Interestingly, the opening of any additional U.S. sites could add new information to a past statement made by Frequency Therapeutics Chief Executive Officer, David Lucchino, who said, “We have opened all U.S. sites for our Phase 2a study of FX-322,” according to a November 18, 2019 press release.

More importantly, however, is the great opportunity these new locations could provide to any interested (and eligible) patients living in New York, Texas, Utah, or Virginia.

Clinical Trial Recruitment Locations: EXTENDED EDITION

The following four locations were added to the list of clinical trial sites:

United States, New York
Amherst, New York, United States, 14226

United States, Texas
San Antonio, Texas, United States, 78258

United States, Utah
Salt Lake City, Utah, United States, 84102

United States, Virginia
Richmond, Virginia, United States, 23235

As of February 4, 2020, these four new locations are not yet recruiting patients. However, that could change at any moment. Meanwhile, the other recruitment sites — which were posted back in October — are still actively recruiting.

The other recent changes to the FX-322 clinical trial record involve the study’s Eligibility Criteria. Changes were made to both the Inclusion and Exclusion criteria.

FX-322 Trial Eligibility: REMASTERED

Inclusion Criteria (Nov 2019 vs. Feb 2020)

BEFORE:
Established diagnosis of sensorineural hearing loss by standard audiometric measures that is stable for ≥ 6 months prior to the Screening Visit [no changes greater than 5 decibels (dB) in anyfrequency].

AFTER:
Established diagnosis of stable sensorineural hearing loss by standard audiometric measures for ≥ 6 months prior to the Screening visit (no changes in air conduction greater than 10 dB at a singlefrequency or greater than 5 dB at two contiguous frequencies from the prior audiogram to the Screening audiogram in the study ear).

Exclusion Criteria (Nov 2019 vs. Feb 2020)

BEFORE:
Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear.

AFTER:
Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear at the Screening visit or on the prior audiogram (if the Investigator feels there is not a true conductive hearing loss, the Medical Monitor should be consulted).

That’s all for now.

Note: The next actually interesting FX-322 progress update should be arriving in June, which is when Frequency Therapeutics could be ready to report top-line data from the trial.

Want more exclusive hearing loss treatment-related updates? Then you should subscribe to the free email newsletter.

Looking for updates for other related conditions? Check out these other “Treatment Report” pages: Tinnitus, Meniere’s Disease, and Hyperacusis.

Questions, comments, concerns, feedback? Email michael@urgentresearch.com and say hello.

Action on Hearing Loss and Medicines Discovery Catapult team up to launch new “Hearing Medicines Discovery Syndicate”, a collaboration designed to accelerate the “much-needed development” of treatments for hearing loss and tinnitus

http://www.pharmatimes.com/news/new_fast-track_system_for_tinnitus_and_hearing_loss_1321998

New ‘fast-track’ system for tinnitus and hearing loss

Action on Hearing Loss and the Medicines Discovery Catapult have teamed up to launch a new “Hearing Medicines Discovery Syndicate”, a collaboration designed to accelerate the “much-needed development” of treatments for hearing loss and tinnitus.

The collaboration will be partnering with the National Institute for Health Research (NIHR), with academic expertise in hearing research provided University College London Hospitals BRC, Nottingham BRC and Manchester BRC, and the Cell and Gene Therapy Catapult.

Sensorion Announces €5.6m Non-Dilutive Funding to Support SENS-401 Phase 2 Study in Sudden Sensorineural Hearing Loss; French Ministry of Armed Forces to Participate in the Study

https://www.businesswire.com/news/home/20191222005022/en/

https://www.biospace.com/article/releases/sensorion-announces-5-6m-non-dilutive-funding-to-support-sens-401-phase-2-study-in-sudden-sensorineural-hearing-loss-french-ministry-of-armed-forces-to-participate-in-the-study/

Sensorion Announces €5.6m Non-Dilutive Funding to Support SENS-401 Phase 2 Study in Sudden Sensorineural Hearing Loss; French Ministry of Armed Forces to Participate in the Study

Pipeline Therapeutics Completes $30 Million Series B Financing – Proceeds to advance PIPE-505 in hearing loss

https://www.businesswire.com/news/home/20191218005137/en/Pipeline-Therapeutics-Completes-30-Million-Series-Financing

Pipeline Therapeutics’ lead candidate, PIPE-505, is entering Phase 1b/2a testing to treat mild-to-moderate sensorineural hearing loss (SNHL) associated with cochlear synaptopathy. PIPE-505 is uniquely positioned to treat this patient population as it can have an impact on both audibility and speech intelligibility, addressing two separate pathologies associated with hearing loss.

Pipeline Therapeutics Completes $30 Million Series B Financing – Proceeds to advance PIPE-505 in hearing loss

SENS-401 shows capacity to reduce central auditory neuron loss after acoustic trauma in preclinical studies

https://www.businesswire.com/news/home/20191106005839/en/Sensorion-Announces-Oral-Presentation-New-SENS-401-Preclinical/

Sensorion Announces an Oral Presentation of New SENS-401 Preclinical Data at ISIET 2019 in Hannover: An oral presentation on the capacity of SENS-401 to reduce central auditory neuron loss after acoustic trauma in preclinical studies

SENS-401 shows capacity to reduce central auditory neuron loss after acoustic trauma in preclinical studies

Sensorion Announces a Poster Presentation of New SENS-401 Preclinical Data at SFN 2019 in Chicago

https://www.businesswire.com/news/home/20191022006061/en/Sensorion-Announces-Poster-Presentation-New-SENS-401-Preclinical

Sensorion Announces a Poster Presentation of New SENS-401 Preclinical Data at SFN 2019 in Chicago

A poster presentation on the absence of impact due to acoustic trauma on the SENS-401 inner ear exposure in preclinical studies

Sensorion Announces a Poster Presentation of New SENS-401 Preclinical Data at SFN 2019 in Chicago
A poster presentation on the absence of impact due to acoustic trauma on the SENS-401 inner ear exposure in preclinical studies

UPDATE: Frequency Therapeutics Expands List of FX-322 Clinical Trial Locations…

The phase 2a study of FX-322 in Adults With Stable Sensorineural Hearing Loss is now recruiting at 12 locations in 8 different states.

Previously, the only clinical trial location listed on the study page was in North Carolina. Not anymore…

Here is the expanded list featuring 11 new locations in 7 other states:

List of FX-322 Phase 2a Clinical Trial Locations

  1. Fresno, California, United States, 93720
  2. Torrance, California, United States, 90503
  3. Colorado Springs, Colorado, United States, 80909
  4. Boca Raton, Florida, United States, 33487
  5. Sarasota, Florida, United States, 34239
  6. Tampa, Florida, United States, 33612
  7. Louisville, Kentucky, United States, 40207
  8. Omaha, Nebraska, United States, 68118
  9. Durham, North Carolina, United States, 27713
  10. Winston-Salem, North Carolina, United States, 27103
  11. Orangeburg, South Carolina, United States, 29118
  12. San Antonio, Texas, United States, 78240

This information was found on the official FX-322 phase 2a study record page, which was recently updated to include these new study locations on Thursday, October 17, 2019.

MORE locations expected?

Could even more locations be added to this phase 2a study?

It’s possible.

However, based on the study’s estimated enrollment — limited to 96 participants — it seems unnecessary.

And what about FX-322 trials outside of the United States? Nothing to report yet. (That will be the topic of a separate post.)

Recruitment Status: Recruiting

As of Saturday, October 19, 2019, all 12 of the study locations listed above are now recruiting participants.

Frequency Therapeutics Begins Recruiting for Phase 2 Study of FX-322 in Patients with Sensorineural Hearing Loss

Frequency Therapeutics is now recruiting patients for phase 2 of its clinical trial of FX-322 in patients with sensorineural hearing loss.

This phase 2a study will assess the exploratory efficacy, as well as the local and systemic safety of single and repeat intratympanic doses of FX-322 compared to placebo in approximately 96 subjects with stable mild to moderately severe sensorineural hearing loss, with a medical history consistent with either excessive noise exposure or idiopathic sudden sensorineural hearing loss.

The study was added and updated to ClinicalTrials.gov on October 9, 2019.

There IS a placebo group… and…

Estimated enrollment is 96 participants and the first recruiting location is North Carolina.

The study is titled FX-322 in Adults With Stable Sensorineural Hearing Loss and can be found on ClinicalTrials.gov at this link: https://clinicaltrials.gov/ct2/show/NCT04120116?type=Intr&cond=Hearing+Loss&lupd_s=09%2F25%2F2019&lupd_d=14&sort=nwst

Signs of Improved Hearing With Progenitor Cell Activator (FX-322)

https://www.medpagetoday.com/meetingcoverage/aaohnsf/82242

Signs of Improved Hearing With Progenitor Cell Activator
Some pure tone improvement, significant increases in word recognition

https://journals.sagepub.com/doi/full/10.1177/0194599819858141f

WSJ: Cures for Hearing Loss May Be Found in New Drugs

https://www.wsj.com/articles/cures-for-hearing-loss-may-be-found-in-new-drugs-11568599440

Cures for Hearing Loss May Be Found in New Drugs

Researchers are trying to counter the biological causes of hearing loss—rather than just treating the effects

Researchers find proteins that might restore damaged sound-detecting cells in the ear

https://www.sciencedaily.com/releases/2019/08/190805101127.htm

Researchers find proteins that might restore damaged sound-detecting cells in the ear
Date:
August 5, 2019
Source:
Johns Hopkins Medicine
Summary:
Using genetic tools in mice, researchers say they have identified a pair of proteins that precisely control when sound-detecting cells, known as hair cells, are born in the mammalian inner ear. The proteins may hold a key to future therapies to restore hearing in people with irreversible deafness.

Research Spotlight: Avenanthramide-C (AVN-C) prevents noise- and drug-induced hearing loss while protecting auditory hair cells from oxidative stress

https://www.nature.com/articles/s41420-019-0195-1

https://www.ncbi.nlm.nih.gov/pubmed/31312524?dopt=Abstract

Avenanthramide-C prevents noise- and drug-induced hearing loss while protecting auditory hair cells from oxidative stress.

Cell Death Discov. 2019;5:115

Authors: Umugire A, Lee S, Kim D, Choi M, Kim HS, Cho HH

Abstract

Noise exposure or ototoxic drugs instigate various types of damage to the cochlea, resulting in hearing loss (HL). While the incidence of HL is growing continuously, there are, so far, no adequate drugs to prevent or treat HL. Avenanthramide (AVN), a natural product extracted from oats, has been reported to possess anti-oxidant/inflammatory properties, and protect several types of cells. In this study, we investigated whether AVN-C can protect auditory hair cells, and preserve hearing from noise trauma and ototoxic drugs. Wild-type C57BL/6 mice were used to generate several HL models. Serum and perilymphatic fluid samples were analyzed using mass spectrophotometry to detect AVN-C. AVN-C crossed the blood-labyrinth barrier, and was detected in the perilymph after systemic injection. Pretreatment by AVN-C 24โ€‰h before exposure to temporary threshold shift noise contributed to the preserving hearing. Moreover, in the case of permanent threshold shift, AVN-C provided significant protection from noise. AVN-C also strongly protected against deterioration in hearing due to kanamycin and furosemide (Kโ€‰+โ€‰F). According to the results of our scanning electron microscopy analysis, many outer hair cells (OHCs) were destroyed by noise trauma, while AVN-C prevented these losses. OHC loss due to Kโ€‰+โ€‰F was even more severe, even affecting the apex. Strikingly, AVN-C treatment maintained OHCs at a level comparable to normal cochlea. AVN-C reduced the dichlorofluorescin (DCF)-positive population in gentamicin-treated HEI-OC1 in vitro. The expressions of TNF-a, BAK, IL-1b, and Bcl-2 were attenuated by AVN-C, revealing its antioxidant effects. The results of this study show that AVN-C crosses the blood-labyrinth barrier and provide a significant protection against noise- and drug-induced ototoxicity. Hence, AVN-C is a good candidate for future therapy aimed at protecting against sensorineural HL.

PMID: 31312524 [PubMed]

Sound Pharmaceuticals announces positive topline results from SPI-1005 Phase 2b clinical trial… clinically relevant improvements in sensorineural hearing loss… 65% and 95% over placebo at 8 weeks…

https://finance.yahoo.com/news/sound-pharmaceuticals-announces-positive-topline-130000754.html

Sound Pharmaceuticals announces positive topline results from SPI-1005 Phase 2b clinical trial… clinically relevant improvements in sensorineural hearing loss… 65% over placebo at 8 weeks

Triamcinolone a Safe and Efficacious Treatment Option for Idiopathic Sudden Sensorineural Hearing Loss, Study Says

https://www.ncbi.nlm.nih.gov/pubmed/31192900?dopt=Abstract

https://journals.lww.com/otology-neurotology/Abstract/2019/07000/Intratympanic_Triamcinolone_Acetonide_as_Treatment.4.aspx

Intratympanic Triamcinolone Acetonide as Treatment Option for Idiopathic Sudden Sensorineural Hearing Loss.

Otol Neurotol. 2019 Jul;40(6):720-727

Authors: Dahm V, Nieratschker M, Riss D, Kaider A, Auinger A, Honeder C, Arnoldner C

Abstract

INTRODUCTION: Corticosteroids represent the most commonly used treatment option for patients with idiopathic sudden sensorineural hearing loss. In the past, these compounds were mainly formulated and tested for intravenous or oral administration. Intratympanic application is increasingly being used, often as salvage treatment. The most suitable corticosteroid for local application has yet to be identified. Trials have suggested that triamcinolone acetonide has superior molecular properties for this treatment modality.

METHODS: The main aim of this study was to retrospectively assess the first audiometric results of patients diagnosed with idiopathic sudden sensorineural hearing loss and treated simultaneously with systemic prednisolone and intratympanic triamcinolone acetonide. This data was then compared to systemic treatment only, as well as to historic cohorts treated intratympanically with widely used corticosteroids, namely dexamethasone or methylprednisolone.

RESULTS: 90 patients received intravenous prednisolone only, and 89 individuals underwent intravenous treatment combined with three to four simultaneous intratympanic applications of triamcinolone. Eight patients received intratympanic triamcinolone as first-line treatment. After adjusting data for sex, time since onset, age, and severity of hearing loss, no statistically significant difference between the two main treatment groups could be identified. No major adverse events were observed, specifically no otitis media or persistent vertigo. Two perforated tympanic membranes healed spontaneously within several days.

CONCLUSION: While the exact role of intratympanic injections requires additional trials, triamcinolone resulted in similar outcomes compared to studies using dexamethasone or methylprednisolone. Due to favorable pharmacological properties, triamcinolone represents a safe and efficacious alternative for intratympanic treatment in idiopathic sensorineural hearing loss.

PMID: 31192900 [PubMed – in process]

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