I would LOVE to know how folks get accepted to clinical trials?!? I’d give my EARS to try a drug that could improve hearing and cure my 24x7 ringing ears. I just don’t know whose door to knock on.
FDA clinical trials for hearing loss are all listed here:
… and now a further 62 million dollars in Series C funding.
It appears as though Frequency Therapeutics is planning an IPO:
https://www.sec.gov/Archives/edgar/data/1703647/000119312519239976/d72917ds1.htm
The document includes results from their last trial.
Results:
No statistically significant results in audiometry scores, though 4 out of 6 participants with moderate-to-moderately severe hearing loss did show improvements of 10Db at 8000k.
Overall about 30% improvement in wrs. Four out of that same group of 6, “showed clinically meaningful” improvements in wrs. Those same four subjects also showed significant improments in speech in noise.
Reddit seems to find those results underwhelming. I’m unsure.
If it was 10db over the full frequency range that would be very significant for me. It might bring back some dead regions also.
I agree. The highest frequencies are closest to the entrance to the cochlea (I believe), so they get the effects of the drug first. The next trial will have up to four injections at weekly intervals. Not sure if they’ll keep the same concentration of active ingredients or tweak it.
Improvements in wrs in 4 subjects were kind of impressive on paper. Depends how much creedence you place in word recognition scores I guess. Unsure how you can get improvements in wrs without the pure tone thesholds moving. Maybe someone can explain that to me.
I don’t have the details at hand, but wasn’t it a pretty small sample size? It’s possible the impact on WRS was entirely random. It’s also feasible that there was some “training” going on.
Yep. Very small sample size. When done properly (and I’m not saying it was in this case- I don’t have the expertise to say), statistical significance takes account of sample size. So big effect with small sample size or small effect with big sample size can both be statistically significant. A p value of .05 (the value that’s usually used to decide whether the results are ‘statistically significant’) means that there’s a 5% chance or less that the results were random. The p on the word-recognition was .01. The placebo group showed 5% improvement- possibly training.
I’m still on the fence on this study. I think the validity and usefulness of word recognition scores is the biggest question. That and the lack of shift in hearing thresholds has dented my optimism by quite a lot.
Clearly they think there’s potential to get good enough results to make notable amounts of money. I’m still pretty skeptical. I remember from previous discussions of WRS that Neville expressed opinion that it was not a very precise measurement with wide confidence levels. The changes in audiometry levels do not explain the change in WRS scores so I think there’s either something else going on (who knows, maybe it improves brain function), or it’s random. 1 in a 100 events happen every day.
Some day damaged inner ear cells will be restored, but if you’ve attended or reviewed any “high level” medical presentations on nerve cell regeneration you will realize its a good ten (plus) years off. More like fifteen years. Odds are medical science will find a cure for baldness way before they find a cure for nerve deafness. As if losing hair is a life altering crisis.
WRS variance can be ~6-30%. Those changes in WRS probably aren’t as big as they look. I’d also be interested to know whether they are using the same word list 30 days later.
@hold4triple. More treatment than cure I think. In the case of FX-322, I think it will either be approved or abandoned within 5 years. It’s an easy drug to test.
@Neville. I think there might have been no effect or maybe a minor training effect in the untreated ear and in the placebo group. Would rule out artifacts like repeating the word list I think. It would have been a real mickey mouse study if they didn’t have multiple and randomized word lists. Also the same 3 or 4 who showed the significant improvement in wrs scores were the same people who showed 10-15 db improvements in thresholds at 8k. That might be some corroboration. On the other hand, very tiny numbers. The 2a study will be interesting. Much higher numbers, a more carefully targeted group of subjects, and multiple dosing.
This reminds me a bit of the hair regrowth (your head) medication called Rogaine. It seemed to work for some people but not for all users. I’m actually excited about this development because even a 5-10 db improvement in the high frequency range would be a welcome outcome for many people and would make it worth the investment to try the medication. Please keep posting this information.
I think they’re hoping for even greater improvements beyond 8k. The current study will test for improvements in extended high frequencies. This seems to be where they believe that increases in ‘clarity’ will come from. Many people will be skeptical about that I know.
Another article here: Frequency's hearing loss treatment shows long-term promise.
@Neville or anyone else…
Two separate quotes from experts. Which one is right?
A 10-decibel improvement is really a tripling in the ability to hear a tone at that particular pitch,” said Frequency Chief Development Officer Carl LeBel, Ph.D.
An improvement of 10 decibels at 8000 hertz is also almost a negligible gain, adds University of Iowa’s Gantz, “within test, retest variability of an audiogram,” he says.
The second one. This first one is conflating changes in sound intensity with signal detection and is actually a bit nonsensical.
It was never anything more than a house of cards.
I agree a total failure!