FX-322

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].

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.

Email michael@urgentresearch.com and say hello. Let me know what type of hearing loss treatment updates you like best. Feedback encouraged.

Also, remember to check out TinnitusTreatmentReport.com if you don’t already know about it.

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

---

Get email updates (while you still can)

The Hearing Loss Treatment Report newsletter will be starting soon. It is a once-weekly email update that will be sent out every Saturday. It is free, your email address will remain private and not be shared with anyone, and you can unsubscribe at any time with a single click.

Click here to subscribe to email updates

(Note: If you have already submitted your email and added your name to the updates list, you are all set. You do not need to sign up again! You’re on the list and will receive updates as soon as they begin.)

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.

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