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
How much will FX-322 cost? David Lucchino, Frequency Therapeutics CEO, talks pricing and value…
Frequency Therapeutics Completes Enrollment of FX-322 Phase 2a Study for Sensorineural Hearing Loss
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.
Frequency Therapeutics Shares Clinical Data From Exploratory Study Confirming Delivery of FX-322 to the Cochlea – Top-Line Results Show Consistent Drug Entry in All Patients
Frequency Therapeutics Provides Business Updates and Reports Third Quarter 2019 Financial Results
Initiated FX-322 Phase 2a clinical study for sensorineural hearing loss
Granted FDA Fast Track designation for FX-322
Completed an $88.6 million initial public offering in October 2019, providing Company runway into 2022
“This has been a tremendously productive period for Frequency as we commenced our Phase 2a study, received Fast Track designation for FX-322, and completed key financings that we believe will enable us to advance our hearing program and further diversify our portfolio as we apply our progenitor cell activation platform in numerous disease areas,” said Frequency Therapeutics Chief Executive Officer David Lucchino. “We have opened all U.S. sites for our Phase 2a study of FX-322 and remain on track to report top-line data in the second half of next year. We believe FX-322 has the potential to be a restorative, disease-modifying treatment for the millions of patients with hearing loss, with the aim of improving hearing function, including speech intelligibility. We also continue to advance our multiple sclerosis development efforts and remain focused on moving our remyelination program into the clinic in the second half of 2021.”
Frequency Therapeutics Commences Dosing in its Phase 2a Study of FX-322 for Sensorineural Hearing Loss; FDA Grants FX-322 Fast Track Designation
Some more information about the upcoming presentation and study, Phase 1/2 Hearing Loss Trial of Intratympanic FX322, a Progenitor Cell Activator, has been posted on the AAO-HNSF 2019 conference website.
This information was previously embargoed (fully), but this abstract/preview has just been made public:
Background: Study Objectives: Although most species can regenerate hair cells, hair cell loss in mammals is permanent because the subset of supporting cells that serve as hair cell progenitors during development fail to divide and differentiate on their own. This work showed that two small molecules that now comprise FX322 restore the regenerative potential of mouse and human progenitor cells in vitro and regenerate hair cells when applied to ototoxin damaged mouse tissue. Importantly, a single intratympanic injection of FX322 restores hair cells and auditory function in mice with trauma within one month after treatment. Utilizing small molecules to regenerate hair cells could provide a therapeutic advantage over the complexities and challenges associated with gene and cell therapies. This preclinical body of data supported the start of the first clinical trial of FX322 in patients with sensorineural hearing loss. Methods: The trial was conducted at three private US otolaryngology practices to assess the systemic safety, plasma PK, and effects on otoscopy, audiometry, and word testing of locally-delivered FX322. The trial was double-blinded, placebo-controlled and enrolled 23 patients with medical histories consistent with either noise-induced hearing loss or sudden sensorineural hearing loss which was considered stable (no change ≥10dB at any frequency, ≥6 months, PTA ≤70dB). Patients were randomized to either placebo or FX322 at two different dose volumes, and treatment was given as a single intratympanic dose. Patients were monitored overnight for safety and PK, and returned at months 0.5, 1, 2 and 3 for otoscopy, audiometry and word testing. Results: As of the date of this writing the study remains blinded and final results will be presented at the annual AAO-HNS meeting.
Expect more information on the day of the presentation: September 17, 2019.
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Frequency will use the proceeds to support the clinical development of FX-322, a regenerative therapeutic for the treatment of sensorineural hearing loss that is moving into a Phase 2a study, and to advance discovery programs in other therapeutic areas using its proprietary Progenitor Cell Activation (PCA) platform.
Astellas picks up Frequency’s regenerative hearing loss med outside U.S. for $80M
Latest FX-322 study results… earlier than expected?
The upcoming presentation, “Phase 1/2 Hearing Loss Trial of Intratympanic FX322, a Progenitor Cell Activator,” was previously scheduled for September 18, 2019.
But according to the AAO-HNSF Annual Meeting website, the presentation date has been changed from September 18 to September 17.
Here is the updated schedule and a link to the page where this information can be found:
Title: Phase 1/2 Hearing Loss Trial of Intratympanic FX322, a Progenitor Cell Activator
Session: Late Breaking Scientific Oral Presentations
Location: Ernest N. Morial Convention Center, Room 286/287
Date: Tuesday, Sep 17 8:24 AM
Could the date of the presentation be changed again? It’s possible. But the conference takes place between September 15 – 18, 2019… so, any scheduling changes should still stay within that date range.
Check the front page of this site for more updates OR sign up for free email updates, which will be sent out once-a-week starting June 21. (Note from admin: I’m still setting up the newsletter system, it will be ready soon!)
Lead FX-322 study investigator, Susan King, will be presenting the latest FX-322 clinical trial results publicly, for the first time, this September. She will be joined by her six co-authors – including Will McLean, Co-Founder of Frequency Therapeutics.
The new FX-322 results and supporting data that will be referenced in Susan King’s scientific presentation, “Phase 1/2 Hearing Loss Trial of Intratympanic FX322, a Progenitor Cell Activator,” are not yet public. They have not yet been published. Both abstract and full text are currently “embargoed information” (and unlikely to be available online or in print until mid September, at the earliest).
Where FX-322 is “at” right now…
Last month, on April 9th, Frequency Therapeutics announced in a press release the positive results of their Phase 1/2 safety trial of FX-322. The company also shared its plans to present these very exciting human trial results “at a major otolaryngology meeting in 2019.”
This was great news… but they did not give us any other details. They did not tell us which otolaryngology meeting. They did not give us a date. They did not give us much. Instead, all we got was a hint…
Which is perhaps why so many people have been feeling in the dark about FX-322 recently… and also why so many people are getting hungry for updates.
Well, now we have an update that eliminates some of this looming uncertainty…
UPDATE: The date has been changed from September 18 to September 17. The information in this post, including location, date, and time, have been changed since this post was first published.
Title: Phase 1/2 Hearing Loss Trial of Intratympanic FX322, a Progenitor Cell Activator
Session: Scientific Oral Presentations: Otology/ Neurology
Location: Ernest N. Morial Convention Center, New Orleans Theater A
Date: Wednesday, Sep 18 9:21 AM
The most exciting part?
September 18 and the official release of the study results will act as a trigger for some even bigger updates. For example, the FX-322 Phase 2a clinical trial can only be initiated once the previous part of the study’s results are submitted for review and confirmed. So, we can probably expect yet another announcement about the status of Phase 2a, shortly after this presentation.
That’s all for now.
More information about AAO-HNSF 2019:
September 15 – 18, 2019
New Orleans, LA
About the Meeting:
The AAO-HNSF Annual Meeting & OTO Experience is “the world’s best gathering of otolaryngologists.” Held each fall, the AAO-HNSF Annual Meeting & OTO Experience provides an opportunity for thousands of Academy members, non-member physicians, allied health professionals, administrators, and exhibiting companies to converge for an exhilarating four days.
UPDATE (schedule has been changed):
For exclusive updates about FX-322 and other not-yet-available tinnitus treatments, subscribe to email updates. For a full list of previous FX-322 updates, all on one page, go here: https://www.tinnitustreatmentreport.com/tag/fx-322/
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This exciting information was found in a local news story about Frequency Therapeutics and FX-322 posted last night.
Local company working on treatment to reverse hearing loss
The article appears to have been published online yesterday, and it is
dated “Updated: 7:58 PM EST Mar 1, 2019″…
I have not had a chance to investigate, but I am wondering…
Was this clever plan to fast track FX-322 (if all goes well) by connecting it with dementia and other fast-track-friendly conditions mentioned anywhere else… before yesterday?
Was this real news or recycled news? Either way, it’s exciting to consider…
If all goes well, Frequency Therapeutics plans on asking the FDA to fast track the drug, citing recent studies that link hearing loss to other diseases like depression and dementia.
Can this “loophole” apply to other drugs, not just FX-322? and allow pharma companies to fast track promising tinnitus treatments as long as they are somehow related to “more serious” conditions and risks of withholding the drug (e.g. risk of suicide)? All these questions would certainly make for an eye-opening discussion.
Frequency Therapeutics Completes $42 Million Series B Financing
>>> original quote from article = Proceeds from the financing will support the advancement of the Company’s clinical candidate, FX-322, for hearing regeneration. Top-line results from an ongoing Phase 1/2 study are expected in the first half of 2019. The financing will also support the continued expansion of Frequency’s pipeline with new therapeutic applications from the Company’s PCA Regeneration platform.
>>> modified quote from article = Top-line results from FX-322 Phase 1/2 study are expected in the first half of 2019
Frequency Therapeutics Completes Enrollment in Single Dose Safety Trial to Evaluate FX-322, a First-in-Class Drug Candidate for Hearing Restoration
WOBURN, Mass.–(BUSINESS WIRE)–Frequency Therapeutics, a clinical stage biotechnology company, today announced the completion of enrollment in the single dose safety trial to evaluate FX-322, a first-in-class drug candidate for hearing restoration from the company’s Progenitor Cell Activation (PCA) Regeneration platform. The randomized, double-blind, placebo-controlled trial is assessing the safety of a single dose of FX-322 given by intratympanic administration in adult patients with stable sensorineural hearing loss (SSHL) who have a medical history consistent with either noise exposure or sudden hearing loss.
Frequency treats first patients in Phase I/II trial of FX-322
Frequency Therapeutics has treated the first patients in a Phase l/ll clinical trial to investigate the safety of FX-322 for the treatment of patients with sensorineural hearing loss.
As part of the randomised, double-blind, placebo-controlled, multi-centre trial, FX-322 will be provided by intratympanic administration in adult patients with stable sensorineural hearing loss (SSHL) who have a medical history of either with noise exposure or sudden hearing loss.
The trial aims to enrol 24 patients at various otolaryngology clinics in the US.
The enrolled patients will receive either an FX-322 injection or a placebo in one ear with an initial follow up visit after two weeks. They will be kept under observation for the following three months.
Frequency Therapeutics clinical advisory board chairman Dan Lee said: “Hearing loss is a condition that has historically not received much attention despite the widespread nature of the issue, due in part to the difficulty of access to the inner ear environment.
“The early work done by Frequency has shown real potential for FX-322 to have a significant impact in patients with noise induced hearing loss.”
“The early work done by Frequency has shown real potential for FX-322 to have a significant impact in patients with noise induced hearing loss.
“While this is a safety study, it is an important first step to examining FX-322 in adult patients with sensorineural hearing loss.”
The Phase l/ll trial is based on Frequency’s first-in-human study completed last year, which demonstrated FX-322 to be well-tolerated and certified the potential of the drug for cochlear penetration when delivered using a standard intratympanic injection in patients scheduled for cochlear implant surgery.
FX-322 is an investigational drug candidate developed for hearing restoration, using Frequency’s Progenitor Cell Activation (PCA) regeneration platform.
Could this new jab mean the end of hearing aids? Experimental treatment injected into the ear could restore hearing by growing new ‘hair’ cells