Frequency Therapeutics — Hearing Loss Regeneration

[Artemis2K]

It's unknown. So just saying "multiple doses didn't work" is misleading. And FREQ hasn't bothered investigating timing of the dosing, or any other alternative routes. They have discussed "multiple single doses" in the past, which might hint that the redosing happens significantly apart, where the first dose has fully dissipated.

Hopefully that can be revisited somehow, even if after the trials are finished.

Thank you for posting this. I've been so horribly depressed lately. I know this ultimately means nothing for the next decade, probably, but these posts are the only thing that I can be hopeful about in life.

Keep in mind that there is no other competing product to compare to, which could make Phase 3 go through really quickly. It's in the middle of Phase 2, which usually can take about 2 years, and Phase 3 can take 1-4 years. If a miracle happens, maybe it could be available for the market by 2025 or 2026. If everything continues to go smoothly, which I'm sure it will at the rate they're going, it'll be available in the near future.

 

[Chad Lawton]

Hopefully that can be revisited somehow, even if after the trials are finished.

Keep in mind that there is no other competing product to compare to, which could make Phase 3 go through really quickly. It's in the middle of Phase 2, which usually can take about 2 years, and Phase 3 can take 1-4 years. If a miracle happens, maybe it could be available for the market by 2025 or 2026. If everything continues to go smoothly, which I'm sure it will at the rate they're going, it'll be available in the near future.

The company has said that they will re-visit multi dosing later on down the road. Their main concern right now is to get it to market ASAP in order to unlock a revenue stream to keep the company funded.

They are actually at the very end of Phase 2 and they are counting this 2b study as a pivotal. There is a small chance that FDA could approve it upon a positive readout from the current study. Approximately half of new drugs over the last decade have been approved on a single positive pivotal trial and seeing that FREQ has proven safety by dosing over 200 subjects and this is now technically their 6th study, it could happen. Even if it doesn't and they still have to go through Phase 3 before approval, it will still likely make it to market by or around 2026.

 

[SmallRonnie]

Hopefully that can be revisited somehow, even if after the trials are finished.

Keep in mind that there is no other competing product to compare to, which could make Phase 3 go through really quickly. It's in the middle of Phase 2, which usually can take about 2 years, and Phase 3 can take 1-4 years. If a miracle happens, maybe it could be available for the market by 2025 or 2026. If everything continues to go smoothly, which I'm sure it will at the rate they're going, it'll be available in the near future.

I think there's a good chance the results of the current trial will be good since they recruited patients with the type of hearing loss that reacted better in previous trials. Of course, anything can happen but there's reason to be optimistic at least.

Phase 2b readout is going to be in the second half of Q1, from their slides. Gonna be late March most likely.

 

[RingingBrother]

The company has said that they will re-visit multi dosing later on down the road. Their main concern right now is to get it to market ASAP in order to unlock a revenue stream to keep the company funded.

They are actually at the very end of Phase 2 and they are counting this 2b study as a pivotal. There is a small chance that FDA could approve it upon a positive readout from the current study. Approximately half of new drugs over the last decade have been approved on a single positive pivotal trial and seeing that FREQ has proven safety by dosing over 200 subjects and this is now technically their 6th study, it could happen. Even if it doesn't and they still have to go through Phase 3 before approval, it will still likely make it to market by or around 2026.

Do you think we'll have expanded access in Phase 3?

 

[Brian Newman]

Hopefully that can be revisited somehow, even if after the trials are finished.

Keep in mind that there is no other competing product to compare to, which could make Phase 3 go through really quickly. It's in the middle of Phase 2, which usually can take about 2 years, and Phase 3 can take 1-4 years. If a miracle happens, maybe it could be available for the market by 2025 or 2026. If everything continues to go smoothly, which I'm sure it will at the rate they're going, it'll be available in the near future.

Where are you getting those dates from Phase 2? Results come out this March?

And if you're talking about tinnitus too, Dr. Susan Shore's device is extremely promising. That will be available in the next year or two.

I have hope for lots of hearing stuff; only one that I'm pessimistic for is noxacusis unless FX-322 helps it too. It could skip Phase 2 and go to market but I think that's unlikely.

Tinnitus will have something pretty soon.

 

[Artemis2K]

The company has said that they will re-visit multi dosing later on down the road. Their main concern right now is to get it to market ASAP in order to unlock a revenue stream to keep the company funded.

They are actually at the very end of Phase 2 and they are counting this 2b study as a pivotal. There is a small chance that FDA could approve it upon a positive readout from the current study. Approximately half of new drugs over the last decade have been approved on a single positive pivotal trial and seeing that FREQ has proven safety by dosing over 200 subjects and this is now technically their 6th study, it could happen. Even if it doesn't and they still have to go through Phase 3 before approval, it will still likely make it to market by or around 2026.

That's great! Hopefully FX-345, that is supposed to be able to treat up to 4 kHz, will be available on the market in the near future as well. I'm guessing it'll probably be closer to 2030 for that though. Really hope they can come up with a way to treat the lower frequencies.

 

[lello]

I took a look at the previous slides, but one thing is not clear to me: in percentage terms, how much hearing loss could be recovered?

I have severe hearing loss up to 2,000 Hz and profound hearing loss from 2,000 Hz onwards: can an improvement from severe/profound to medium hearing loss be presumed?

PS: I'm Italian and I don't have much command of the English language. Google also doesn't help me in translating PDF files.

 

[Nick47]

I have severe hearing loss up to 2,000 Hz and profound hearing loss from 2,000 Hz onwards: can an improvement from severe/profound to medium hearing loss be presumed?

Do you have single-sided hearing loss? Profound hearing loss from 2000 Hz - 8000 Hz? Viral infection?

Should you consider a cochlear implant?

I don't see any real evidence of raised audiogram in any previous studies, given that 10 dB is not significant as people's hearing can range by that much day to day. Only success I've seen is word recognition or speech-in-noise for FX-322.

 

[lello]

Do you have single-sided hearing loss? Profound hearing loss from 2000 Hz - 8000 Hz? Viral infection?

Should you consider a cochlear implant?

I don't see any real evidence of raised audiogram in any previous studies, given that 10 dB is not significant as people's hearing can range by that much day to day. Only success I've seen is word recognition or speech-in-noise for FX-322.

I suffer from bilateral hearing loss due to ototoxic drugs.

From 100 Hz to 2000 Hz I have an average loss of 70-80 dB, while from 2000 Hz to 8000 Hz the loss is 100-110 dB on average.

I don't understand how FX-322 can improve word recognition if it doesn't improve the audiogram.

10 dB improvement seems very low to me

 

[Nick47]

I suffer from bilateral hearing loss due to ototoxic drugs.

From 100 Hz to 2000 Hz I have an average loss of 70-80 dB, while from 2000 Hz to 8000 Hz the loss is 100-110 dB on average.

I don't understand how FX-322 can improve word recognition if it doesn't improve the audiogram.

10 dB improvement seems very low to me

Really sorry to hear this. Yea I'm a big believer in audiogram improvement but FX-322 seems to help some with word recognition. Maybe higher frequencies 8000+ Hz will see some improvement, I'm not sure. I'm generally not enthused by this product and don't understand the hype but if results are good, it's a winner.

You sound like a big candidate for cochlear implants and I advise you to discuss this with an ENT.

 

[Artemis2K]

I suffer from bilateral hearing loss due to ototoxic drugs.

From 100 Hz to 2000 Hz I have an average loss of 70-80 dB, while from 2000 Hz to 8000 Hz the loss is 100-110 dB on average.

I don't understand how FX-322 can improve word recognition if it doesn't improve the audiogram.

10 dB improvement seems very low to me

It's probably because sound waves are a lot more detailed than just those frequencies. Regaining the hearing in those extreme frequencies seems to allow the person to understand/respond better. As for the 10 dB improvement, I don't know.

If the FX-345 works, which I'm sure it will, that will address most of the rest. If they can figure out a way to get it further in, and have the ability to do more injections every few months, then that might solve the other issues.

 

[RingingBrother]

10 dB improvement seems very low to me

Could be enough to get by with just hearing aids and avoid cochlear implant surgery.

Also, a small improvement would help you to wait for the better drug, FX-345, to advance in the trials.

 

[SmallRonnie]

Could be enough to get by with just hearing aids and avoid cochlear implant surgery.

Also, a small improvement would help you to wait for the better drug, FX-345, to advance in the trials.

Patients who have a cochlear implant will not be allowed get FX-322 or FX-345 in the future, if they are ever released, I believe. Not 100% sure on that but think I heard it before.

A cochlear implant still might be the best decision for some people but this is something to keep in mind. It could be too much to keep suffering for years for only a possible different solution in the future.

 

[Ace]

Here is a video from CBS, covering one of the patients who saw improvement from sudden deafness a month after their dose.

 

[CRGC]

Here is a video from CBS, covering one of the patients who saw improvement from sudden deafness a month after their dose.

This is extremely encouraging! Dear Santa, if you're reading this, please give us positive results for the Phase 2b trial <3

 

[Jurger]

Here is a video from CBS, covering one of the patients who saw improvement from sudden deafness a month after their dose.

Interesting. I wonder when the gentleman participated in the trial. If it was one of the earlier ones, his recovery could be attributed to the natural healing that occurs over time in a lot patients with sudden deafness (particularly word recognition). Also, I wonder how much he recovered.

EDIT: apparently he got the drug 18 months after being hit with sudden deafness.

 

[Nick47]

When I watched the video, it reminded me of Hough Ear Institute, where recently they dragged someone up to say their tinnitus had been treated. You should read nothing into these case studies.

 

[Artemis2K]

Here is a video from CBS, covering one of the patients who saw improvement from sudden deafness a month after their dose.

That's quite a surprising result for a drug that only covers the ultra high frequencies. It's definitely very encouraging.

 

[Fightthearmy]

This is extremely encouraging! Dear Santa, if you're reading this, please give us positive results for the Phase 2b trial <3

If only there was a dislike button...

No double-blinding, ceteris paribus, no science.

 

[Diesel]

Here is a video from CBS, covering one of the patients who saw improvement from sudden deafness a month after their dose.

I wonder if he was patient 937 from the Phase 1/2?

 

[DimLeb]

Smells like super BS. So far the studies talked about only a 10 dB improvement and only above 8 kHz which is far from the significant improvement they talk about. It's probably promo lies like the Hough Ear Institute, or what happened was a rare natural regeneration.

 

[Artemis2K]

Smells like super BS. So far the studies talked about only a 10 dB improvement and only above 8 kHz which is far from the significant improvement they talk about. It's probably promo lies like the Hough Ear Institute, or what happened was a rare natural regeneration.

10 dB can make a huge difference. I should know, I lost 10 dB this year at 4 kHz. High frequency improvement can help with clarity.

There was quite a time gap between the sudden hearing loss, and his treatment. He already tried the usual emergency treatment, but with no success. If 18 months have gone by, and he received no benefit from the steroid shot, do you really think that it was a temporary threshold shift? Hearing cannot naturally come back after such a long period of time.

 

[Diesel]

If 18 months have gone by, and he received no benefit from the steroid shot, do you really think that it was a temporary threshold shift? Hearing cannot naturally come back after such a long period of time.

He wouldn't have been allowed into the trial (assuming Phase 1/2 based on the description in the video) unless he had demonstrated that his hearing loss was 'stable' at entry. So, his doctor would have had to show to the trial managers that he hasn't improved naturally or by any other means over the 18 month window; that the hearing loss was permanent. The entry criteria of the trial supports your position.

 

[DimLeb]

10 dB can make a huge difference. I should know, I lost 10 dB this year at 4 kHz. High frequency improvement can help with clarity.

There was quite a time gap between the sudden hearing loss, and his treatment. He already tried the usual emergency treatment, but with no success. If 18 months have gone by, and he received no benefit from the steroid shot, do you really think that it was a temporary threshold shift? Hearing cannot naturally come back after such a long period of time.

I really want to believe that this was the case and the drug really works to restore even more d, but it sounds very far-fetched based on the data the company itself has given us.

Actually, I rewatched the video again and he doesn't even mention how much of his hearing he lost. He mentions that he had distorted hearing, maybe some kind of diplacusis or dysacusis, but not classic hearing loss? I'm confused now. Maybe it wasn't even hearing loss that was restored and it was the distorted hearing that was restored spontaneously? Normie language is much different than ours who actually know stuff about our ear issues...

 

[Nick47]

If 18 months have gone by, and he received no benefit from the steroid shot, do you really think that it was a temporary threshold

@Artemis2K, did you see his before and after audiogram?

 

[ColinUK]

I just hope this is true and this drug works. Please let there be some good news in 2023 for us all.

 

[Gb3]

I really want to believe that this was the case and the drug really works to restore even more d, but it sounds very far-fetched based on the data the company itself has given us.

Actually, I rewatched the video again and he doesn't even mention how much of his hearing he lost. He mentions that he had distorted hearing, maybe some kind of diplacusis or dysacusis, but not classic hearing loss? I'm confused now. Maybe it wasn't even hearing loss that was restored and it was the distorted hearing that was restored spontaneously? Normie language is much different than ours who actually know stuff about our ear issues...

He had sudden hearing loss in one ear. It happens. It happened to me and that's exactly what it sounded like.

 

[Artemis2K]

@Artemis2K, did you see his before and after audiogram?

No, but some of the examples of word recognition improvements are on those slides. Since he works at a high school, hearing himself talk with unilateral hearing loss probably was overwhelming, and whatever his hearing loss was, the opportunity to have more frequencies available that improved the richness and clarity of the sound probably made things easier. If it was really a 10 dB improvement, perhaps it was at a level where the threshold improvement allowed some clear reception of the sound.

 

[Jurger]

He had sudden hearing loss in one ear. It happens. It happened to me and that's exactly what it sounded like.

Yes, sudden hearing loss/deafness happens all the time, but I do agree that judging from what we know of the efficacy of FX-322, he seems to be extremely responsive to it.

 

[SmallRonnie]

I just hope this is true and this drug works. Please let there be some good news in 2023 for us all.

End of March is the date for the calendar.