FX-322

Frequency Therapeutics Highlights Clinical Advancement of FX-322 and Unveils FX-345, a New Potential Restorative Treatment for Hearing Loss
November 9, 2021
https://investors.frequencytx.com/news-releases/news-release-details/frequency-therapeutics-holds-virtual-rd-event-highlighting

Comments from the CEO:
“We will also unveil two new research programs that demonstrate the potential of our progenitor cell activation (PCA) approach. First, we will introduce FX-345, a new hearing restoration candidate designed for greater distribution through the cochlea, potentially enabling the treatment of expanded SNHL patient populations.”

Highlights from the press release, copy+pasted:

“FX-345
Introduction of new SNHL investigational therapeutic program, including a more potent GSK3 inhibitor designed to achieve broader exposure of the cochlea.

https://www.businesswire.com/news/home/20211021005166/en/Frequency-Therapeutics-Announces-First-Subject-Dosed-in-FX-322-Phase-2b-Acquired-Sensorineural-Hearing-Loss-SNHL-Study-and-FDA-Agreement-on-Speech-Perception-as-Primary-Endpoint

Frequency Therapeutics Announces First Subject Dosed in FX-322 Phase 2b Acquired Sensorineural Hearing Loss (SNHL) Study and FDA Agreement on Speech Perception as Primary Endpoint

https://investors.frequencytx.com/news-releases/news-release-details/frequency-therapeutics-provides-business-updates-and-reports-5

Frequency Therapeutics Plans to Initiate New FX-322 Phase 2 Study in Second Half of 2021

https://www.businesswire.com/news/home/20210323005208/en/Frequency-Therapeutics-Releases-New-Data-from-Two-FX-322-Clinical-Studies-Plans-to-Advance-Single-Dose-Regimen

Frequency Therapeutics Releases New Data from Two FX-322 Clinical Studies; Plans to Advance Single-Dose Regimen
Interim FX-322 Phase 2a Results Show Four Injection Schedule Had No Discernible Hearing Benefit

Separate FX-322 Phase 1b Study Confirms Hearing Improvement from Single Injection

Conference call at 8:30am ET today

https://www.businesswire.com/news/home/20210222005818/en/Frequency-Therapeutics-Announces-Publication-of-Phase-12-Data-Showing-Hearing-Improvements-in-Acquired-Sensorineural-Hearing-Loss-Patients-Receiving-FX-322

Frequency Therapeutics Announces Publication of Phase 1/2 Data Showing Hearing Improvements in Acquired Sensorineural Hearing Loss Patients Receiving FX-322
Results Published in Leading Peer-Reviewed Otolaryngology Journal, Otology & Neurotology

Statistically Significant Improvements Observed in Word Recognition Tests in Quiet and in Noise; Suggests Potential to Improve Speech Intelligibility, a Major Unmet Need for Individuals with Hearing Loss

Company Expects Interim FX-322 Phase 2a Study Data Later this Quarter

https://journals.lww.com/otology-neurotology/Abstract/9000/Improved_Speech_Intelligibility_in_Subjects_With.95768.aspx

PRESENTATION: “Perspective on the Potential of Restorative Therapeutics for Sensorineural Hearing Loss” (Slides from KOL Event)

https://investors.frequencytx.com/static-files/16a21001-6397-409d-b760-77ef91e9658c

https://investors.frequencytx.com/news-releases/news-release-details/frequency-therapeutics-appoints-quentin-mccubbin-phd-chief

Frequency Therapeutics Appoints Quentin McCubbin, Ph.D., as Chief Manufacturing Officer
WOBURN, Mass.–(BUSINESS WIRE)–Jan. 19, 2021– 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 the appointment of Quentin McCubbin, Ph.D., as chief manufacturing officer. Dr. McCubbin will oversee Company technical operations, leading drug product formulation, chemistry manufacturing and controls (CMC) and supply chain, to support the development of Frequency’s pipeline of product candidates.

Dr. McCubbin joins Frequency from Cerevel Therapeutics, a clinical-stage biotechnology company where he served as head of technical operations. Prior to Cerevel, he spent 19 years at Takeda/Millennium Pharmaceuticals in various roles progressing in responsibility, including six years as vice president of pharmaceutical sciences and global head of process chemistry.

“Quentin’s background and leadership in technical operations will be critical as we prepare for larger studies in support of our lead FX-322 program that aims to treat the most common form of hearing loss, and as we look to diversify and expand our clinical pipeline with a program for remyelination in multiple sclerosis,” sa

Study is no longer recruiting participants. 30 patients enrolled. Half will get a single dose of FX-322, other half will get a placebo. Estimated primary completion date: March 2021. Estimated study completion date: June 2021. Stay tuned…

Link to official study record (last update posted on December 16, 2020):

https://clinicaltrials.gov/ct2/show/NCT04601909

The other recently-added FX-322 study (for severe sensorineural hearing loss) is expected to start before the end of the year, according to a November 16 press release from Frequency Therapeutics.

More updates to follow. Remember to subscribe to the email newsletter, which will begin sending soon. Email michael@urgentresearch.com if you have any comments or feedback.

https://investors.frequencytx.com/news-releases/news-release-details/frequency-therapeutics-provides-business-updates-and-reports-3

Phase 1b Study in Patients with Severe SNHL to Start Before Year End

Added today: A Phase 1b, Prospective, Randomized, Double-Blind, Placebo- Controlled, Single-Dose, Multicenter, Safety Study of FX-322 Administered by Intratympanic Injection in Adults With Severe Sensorineural Hearing Loss.

This is a Phase 1b placebo-controlled, double-blind, single-dose safety study of intratympanic FX-322 dosed in subjects with severe sensorineural hearing loss.

Approximately 30 subjects are planned to be enrolled in this study. The subjects will be randomized to receive one dose FX-322 (24) or placebo (6) and will return for safety, otologic, and audiologic assessments at Days 30 and 90 after the study injection.

What makes this new FX-322 trial different (compared to the trial that was added last month)?

This new study is for severe sensorineural hearing loss (previously added study is for age-related hearing loss). The inclusion criteria requires a “pure tone average of “26-70 dB at 500Hz, 1000Hz, 2000Hz, and 4000Hz at screening in the ear to be injected.”

Does it include a Tinnitus Assessment as a secondary outcome measure?

Yes.

Measured by the Tinnitus Functional Index (TFI), with a scale ranging from 0 to 100 that defines severity categories based on 25 self-reported answers.

What else? More fun facts:

Study is Recruiting and will enroll 30 participants. It does involve a placebo group however the ratio is 4:1 which means most (24) of the participants will get FX-322.

If you like those odds, here are the states where clinical trial sites are located:

• Florida
• Nebraska
• New York
• Texas
• Virginia

Could more locations be added?

Very possible. We will post an update if/when more sites are added.

Here is the official link to the study:

https://clinicaltrials.gov/ct2/show/NCT04629664

More FX-322 updates:

If you want ALL of the FX-322 updates and exclusive hearing loss treatment-updates sign up for the free email newsletter.

https://investors.frequencytx.com/news-releases/news-release-details/frequency-therapeutics-announces-expanded-fx-322-clinical

Frequency Therapeutics Announces Expanded FX-322 Clinical Development Program and Upcoming Day-90 Phase 2a Analysis
Company Will Report Data from Phase 2a Sensorineural Hearing Loss (SNHL) Study in Late Q1 2021

First Patient Dosed in Phase 1b Study of Age-Related Hearing Loss; Additional Phase 1b Study for Severe SNHL Patients to Start This Quarter

https://investors.frequencytx.com/news-releases/news-release-details/frequency-therapeutics-completes-enrollment-fx-322-phase-2a

Frequency Therapeutics Completes Enrollment of FX-322 Phase 2a Study for Sensorineural Hearing Loss

https://www.fiercebiotech.com/biotech/frequency-s-hearing-loss-treatment-shows-long-term-promise

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

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.

https://investors.frequencytx.com/news-releases/news-release-details/frequency-therapeutics-shares-clinical-data-exploratory-study

Frequency Therapeutics Shares Clinical Data From Exploratory Study Confirming Delivery of FX-322 to the Cochlea

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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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.

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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.

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.

https://www.biospace.com/article/releases/frequency-therapeutics-commences-dosing-in-its-phase-2a-study-of-fx-322-for-sensorineural-hearing-loss-fda-grants-fx-322-fast-track-designation/

Frequency Therapeutics Commences Dosing in its Phase 2a Study of FX-322 for Sensorineural Hearing Loss; FDA Grants FX-322 Fast Track Designation

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

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

https://www.frequencytx.com/news-events/news-events-press-release-07-23-2019.php

Investor dollars flow to Frequency Therapeutics as company prepares to advance lead clinical candidate, FX-322, into Phase 2a study of sensorineural hearing loss, a condition for which there are no approved therapies…

https://www.fiercebiotech.com/biotech/astellas-picks-up-frequency-s-regenerative-hearing-loss-med-outside-u-s-for-80m

https://scrip.pharmaintelligence.informa.com/SC125552/Astellas-Adds-To-Regenerative-Medicine-Portfolio-In-Hearing-Loss-Deal-With-Frequency

Astellas Adds To Regenerative Medicine Portfolio In Hearing Loss Deal With Frequency