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Hearingup
hearingup.com › videos › the-cure-for-hearing-loss-part-2-fx-322-drug
The CURE for Hearing Loss: Part 2 | FX 322 Drug
Dr. Cliff Olson, Audiologist and founder of Applied Hearing Solutions in Phoenix Arizona, discusses the progress of the first possible Cure for Sensorineural hearing loss - FX322.
Published: December 2, 2022
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Mayo Clinic Connect
connect.mayoclinic.org › discussion › fx-322
FX 322: familiar with the trials on this for hearing restoration?
Is anyone familiar with Frequency Therapeutics and FX 322? Their pill FX322 is in clinical trials to restore hearing loss.
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Medicaldevice-network
medicaldevice-network.com › home › astellas pharma and frequency therapeutics collaborate on hearing loss therapy
Hearing loss therapy FX-322 to be commercialised
August 13, 2024 - Hearing loss therapy FX-322, which tackles sensorineural hearing loss, is being brought to market by Astellas Pharma and Frequency Therapeutics
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GEN
genengnews.com › home › industry news › astellas, frequency therapeutics partner to develop hearing loss drug
Astellas, Frequency Therapeutics Partner to Develop Hearing Loss Drug
June 2, 2023 - Astellas Pharma will partner with Frequency Therapeutics to develop Frequency’s lead candidate—the Phase IIa-bound sensorineural hearing loss regenerative therapeutic FX-322—through a collaboration that could generate more than $625 million for the Woburn, MA-based developer of ...
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Neuro Central
neuro-central.com › home › frequency therapeutics holds virtual r&d event highlighting clinical advancement of fx-322, a new potential restorative treatment for hearing loss and in vivo data for its remyelination program in multiple sclerosis
Frequency Therapeutics Holds Virtual R&D Event Highlighting Clinical ...
November 9, 2021 - Management and Leading KOLs will Provide Detailed Review of Completed FX-322 Clinical Data in Subjects with Sensorineural Hearing Loss (SNHL), Supporting Design of FX-322-208 Phase 2b Study New Hearing Restoration Program Advances Toward Clinical Studies Providing Broader Cochlear Exposure ...
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Thepharmaletter
thepharmaletter.com › pharmaceutical › frequency-therapeutics-tanks-as-hearing-loss-trial-fails
Frequency Therapeutics tanks as hearing loss trial fails | The ...
June 25, 2024 - Shares of US regenerative medicines firm Frequency Therapeutics (Nasdaq: FREQ) plummeted more than 80% to $0.75 yesterday, after it announced it is terminating programs in sensorineural hearing loss (SNHL) because FX-322 failed to meet the goal of a study in people with acquired SNHL, and is ...
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Sunsethq
sunsethq.com › layoff-tracker › frequency-therapeutics
Frequency Therapeutics Layoffs: What Happened & Why?
September 12, 2024 - The layoffs at Frequency Therapeutics were primarily driven by the failure of a mid-stage clinical trial for their lead drug, FX-322, which was intended to treat hearing loss. This setback led to a significant drop in the company's stock price and market capitalization, creating economic pressures ...
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Cochranelibrary
cochranelibrary.com › central › doi › 10.1002 › central › CN-02335042 › full
FX-322 in Adults With Acquired Sensorineural Hearing Loss | Cochrane ...
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Medwatch
medwatch.com › News › hearing_health › article15026142.ece
Frequency pivots after failed trial for hearing loss drug candidate
February 14, 2023 - US biotech company Frequency Therapeutics has been thrust into an existential crisis following another failed trial involving drug candidate FX-322.
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Nature
nature.com › nature communications › articles › article
A phase I/IIa safety and efficacy trial of intratympanic ...
March 1, 2024 - McLean, W. J. et al. Improved speech intelligibility in subjects with stable sensorineural hearing loss following intratympanic dosing of FX-322 in a phase 1b study. Otol. Neurotol.
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Hearinghealthassoc
hearinghealthassoc.com › hearing-health-associates-va-blog › research-watch-first-in-human-safety-study-for-hearing-restoration
Research Watch: First-In Human Safety Study for Hearing Restoration ...
January 25, 2024 - U.S.-based biotech company Frequency Therapeutics is trying to change that. Last month, the company successfully completed the first-in-human study of FX-322, a Progenitor Cell Activation (PCA™) regenerative medicine aimed at creating new inner ear hair cells in the cochlea.
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Reddit
reddit.com › r/hearingaids › hearing loss cure
r/HearingAids on Reddit: Hearing loss cure

I've been following the FX-322 trial, and I'm seriously disappointed. I have sensorineural hearing loss, I might have been a good candidate for the drug if Frequency Therapeutics brought it to market.

My take on the results they've released is that the drug CAN reverse hearing loss, but they haven't yet found a protocol that gives consistent results. This is not unusual for a phase 2 clinical trial; you'd expect them to come back in a few months with a revised set of protocols to test in a new set of phase 2 trials.

But if you read the full press release and do some googling, it becomes clear that Frequency is in serious financial trouble and the CEO/founder is sidelined with serious medical issues.

From the press release:

The Company will immediately reduce headcount as part of an overall restructuring, downsizing personnel by approximately 55 percent. The Company believes that the restructuring will generate sufficient cost savings to extend its runway into 2025 and enable it to complete a first clinical trial of its MS program in 2H 2024. As of December 31, 2022, Frequency had cash, cash equivalents and marketable securities of $83.1 million (excluding restricted cash).

So the company isn't stopping the hearing loss drug trials because it doesn't have potential. Rather, they're venture-funded and running out of cash. They've stopped ALL their research except for the work on this one MS drug, because they think they can get it through clinical trials and sell it before their money runs out.

In the short term, this is bad for us. In the long term, there's still hope, because cash-strapped Frequency may sell the rights to the hearing loss drug to somebody else who could actually finish the trials and bring it to market.

Here's hoping.

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UPI
upi.com › Health_News › 2023 › 02 › 13 › frequency-therapeutics-discontinues-hearing-loss-drug-development › 6391676326548
Hearing loss treatment scrapped as drug company announces ...
February 13, 2023 - Frequency Therapeutics announced it will scrap development of a drug called FX-322 after testing failed to show improvement in speech perception in people with noise-induced sensorineural hearing loss.
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Reddit
reddit.com › r/tinnitusresearch › frequency therapeutics - press release concerning fx-322 study
r/tinnitusresearch on Reddit: Frequency Therapeutics - Press Release ...
February 13, 2023 - I wasn't really surprised by FX-322's failure honestly, the previous trial had poor results and it simply doesn't penetrate deep enough to affect speech perception. What I was surprised by was the termination of FX-345. That drug had way more potential for speech improvement yet it was killed ...
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Fierce Biotech
fiercebiotech.com › biotech › frequency-falters-after-phase-2-fail-axes-program-and-55-staff
Frequency falters after phase 2 fail, axing 2 assets and 55% of staff
February 14, 2023 - However, the biotech’s asset failed to meet the trial’s main efficacy goal, with no significant improvement in speech perception reported among patients receiving FX-322 compared to placebo after 90 days.
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BioPharma Dive
biopharmadive.com › news › frequency-layoffs-cut-jobs-discontinue-hearing-loss › 642596
Frequency to cut jobs after clinical trial setback | BioPharma Dive
February 13, 2023 - Both its lead drug FX-322 and FX-345, its follow-on candidate, were aimed at sensorineural hearing loss, which results from damage to sensory hair cells and is estimated to impact millions of individuals in the U.S.
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Endpoints News
endpts.com › frequency-therapeutics-reports-trial-fail-and-lays-off-over-half-of-staff-stock-capsizes
Frequency Therapeutics reports trial fail and lays off over half ...
February 15, 2023 - Frequency Therapeutics announced Monday morning that its lead candidate, a drug for hearing loss, failed a Phase IIb study. As a result, the Lexington, MA-based biotech will discontinue its hearing loss program and lay off 55% of its staff. And Frequency’s stock $FREQ, which was trading at ...
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Nasdaq
nasdaq.com › articles › frequency-therapeutics:-fx-322-associated-with-hearing-signal-in-placebo-controlled-trial
Frequency Therapeutics: FX-322 Associated With Hearing Signal In ...
December 9, 2021 - (RTTNews) - Frequency Therapeutics, Inc. (FREQ) reported the results from its FX-322-113 study, a placebo-controlled trial evaluating the administration of FX-322 in subjects with severe sensorineural hearing loss. In the study, FX-322 was associated with a hearing signal as sh
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YouTube
youtube.com › this week in hearing
Regenerative Medicine and Hearing Restoration: Update on Frequency ...
18:45
Nearly one year ago, Drs. Kevin Franck and Carl LeBel were on TWiH to discuss the exciting possibilities of regenerative medicine in hearing and the incredib...
Published: December 27, 2022
Views: 11K