Frequency Therapeutics announces breakthrough small-molecule approach to regenerate inner ear sensory hair cells


A recent article:

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Interesting! I would offer an ear for phase 2 testing.



I’ve idly wondered whether I would. If I were single or my kids were grown then probably. The Regain Project trials in the UK stipulated mild to moderate hearing loss of less than 10 years duration as criteria for inclusion. Probably want to maximise their chances of a good result. I wouldn’t qualify.



Do you know if they have a way to sign up for clinical trials? I’m sure they will have no shortage of applicants.



I know they haven’t responded to requests for inclusion in their next trial. Maybe leave your details at CenterWatch Patient Notification System, check your emails, and wait. Their first trial was conducted in Australia. Who knows where they’ll do phase 2?



Great suggestion. I did that!



It looks like the phase 2 study may be happening in Texas. See



These “breakthroughs” come at regular intervals and so far not one of them have come into general clinical use. I wouldn’t plan on scheduling a “treatment” anytime soon since they are probably at least a decade or more away if ever.



I don’t think there’s been any other breakthrough quite as promising as this. Did those other breakthroughs you mention ever make it through to clinical trials? Be as skeptical as you like. I’ve said before that I don’t think anyone should put off buying hearing aids or getting a CI because of this. At the same time I don’t see what’s wrong with being just a little bit optimistic. An actual candidate treatment for sensorineural hearing loss in phase 2 of clinical trials. Wow.



Yes, all the one’s that have been reported on the HAF had gone to clinical trials. I’ve been on the HAF for 8 years and in that time I think there has been at least 6 or 7 reports of breakthroughs in restoring lost hearing. So far none have made it through their trials.



Ok, I’ve kind of adopted this as my thing. Here’s their latest press release quoted verbatim. More importantly there’s a video from their Chief Scientific Officer explaining the concepts. Probably the most succinct explanation I’ve seen. Whether you believe it or not, it’s definitely interesting.




“In the Phase 1/2 study, FX-322 was safe and well tolerated following a single intratympanic injection with no serious adverse events. In addition, improvements in hearing function, including audiometry and word scores, were observed in multiple FX-322 treated patients.”

Am I the only one who sees this as significant?


Hair Cell Regeneration

Am I the only one who sees this as significant?

Not at all - thank you for posting this update!

I don’t always have the time to keep up with all the biotech companies working on this stuff now so I really appreciate the update. Their work gives me tremendous hope that one day we won’t need to wear hearing aids anymore.

What an exciting announcement; I can’t wait to hear more in the coming months.

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Even if FX-322 doesn’t make it to market for whatever reason, this result shows that some reversal of sensorineural hearing loss in humans is possible. Has it ever been done before? If you think of the possible improvements in quality of life for a large swathe of the population in developed countries, this has got to be front page news, surely?




I’m equally excited like you, however, I have to ask myself who this drug will be able to help.
From the company’s website I take that it is designed to recover hearing for those who lost it due to damage like too much loud noise and alike.

Not sure how many people with hearing loss are in this category. Me for my part, I’m not, because my hearing loss has a genetic root cause. I’d love to find out if this drug can also help me, as the genetic disorder also leads to a degradation of hearing over time, but unfortunately no one can tell, not even this company…




@stefan.donath I don’t think even Frequency Therapeutics could say for sure. They are targeting the largest market segment and probably the least-complicated to test and treat. It may be that hair cell regeneration would reset the clock for people with a genetic basis for their hearing loss. So hearing would be restored but begin to degrade again. Maybe periodic treatments? I really don’t know. I guess the good knews is that viable gene therapy seems to be on the distant horizon. Fingers crossed.




I should think that genetic root causes would most "deaf"initely be helped with the drug! I’m in that category, too, with inherited sensorineural hearing loss (translation: BALD in those ear hair patches).

I’d so love to try a drug like this if it didn’t have severe side-effects. Now I’m hoping it won’t all go up in smoke like Theranos! Fingers crossed it hits the market and could be prescribed soon enough.



They are presenting the results of their phase 1/2 trial at a major conference in September. They have already said that ‘multiple’ subjects (that’s at least 2 out of 16 subjects who were giving the drug) showed improvements in hearing thresholds and word recognition scores. Presumably they are going to say how many and by how much at the conference. I’ll definitely be staying tuned for that one.

On a related note, there’s an anecdotal report that one of the participants in the Regain clinical trial in London has bent their confidentiality agreement a little and reported significant improvements in hearing and lowering of tinnitus.

It would be very nice if we had two drugs to treat hearing loss hitting the market (probably years away) at the same time. That would curb price gouging a little.