Frequency Therapeutics — Hearing Loss Regeneration

[paul mclean]

Enrollment of FX-322 Phase 2a Complete:

Frequency Therapeutics Completes Enrollment of FX-322 Phase 2a Study for Sensorineural Hearing Loss

That's really good news. By June next year we should know a lot more. It's already been fast tracked and there is positive results coming out from the phase 1/2 study.

I've seen people mentioning they will attempt to use the Right to Try laws to access FX-322 earlier than usual.

 

[aot]

Even with the Fast Track, this wait is unbearable.

I can't imagine how hard it would be to wait without the Fast Track.

 

[tommyd87]

Even with the Fast Track, this wait is unbearable.

I can't imagine how hard it would be to wait without the Fast Track.

Good things come to those who can wait (and I would say this falls in this category although the wait is unbearable).

 

[sensualmosquito]

I want this stuff to work. Even if it gave me some of my hearing back and curbed the tinnitus and weird distortions I'd be happy. I can be patient though. I keep thinking in my head that this is a temporary thing that I'll have to deal with for years. One day I'll just 3D print a new ear using my own stem cells! Can't wait to take it to mother nature haha.

 

[paul mclean]

Even with the Fast Track, this wait is unbearable.

I can't imagine how hard it would be to wait without the Fast Track.

It probably would come out in 2026-2027 without Fast Track and 2023-2024 with Fast Track.

 

[GlennS]

- The fact that it was safe
- The fact that it caused improvement in people
- The fact that it does what it is supposed to do

Does it, though? We have yet to hear first hand accounts from tinnitus sufferers. Look, I AM optimistic, but I'm not treating this as a done-deal. I mean, even Neuromod had glossy video testimonials. I've learned to be more guarded.

Neuromod made a bimodal stimulation device which will never be anywhere near as effective as FX-322 could or would be.

You could also say that the level of difficulty is much greater to regenerate tissue than to biohack the brain into no longer false-firing ringing noises. Rationalize onward as you will.

 

[aot]

It probably would come out in 2026-2027 without Fast Track and 2023-2024 with Fast Track.

I guess I should consider myself lucky that I'm so young. But still.

 

[paul mclean]

@aot I am 25 and suffering pretty bad. I am over not being able to go to bars and restaurants and people mumbling all the time.

It will be a good day once we all receive treatment and can enjoy silence.

 

[all to gain]

I guess I should consider myself lucky that I'm so young. But still.

"But still"... so unlucky that I got this hideous thing so young.

But yeah, time is on your side.

 

[tomytl]

Does it, though? We have yet to hear first hand accounts from tinnitus sufferers. Look, I AM optimistic, but I'm not treating this as a done-deal. I mean, even Neuromod had glossy video testimonials. I've learned to be more guarded.

You could also say that the level of difficulty is much greater to regenerate tissue than to biohack the brain into no longer false-firing ringing noises. Rationalize onward as you will.

Correct, it's not a done deal. Even if it looks very promising, the possibility of failure is still there.

Even several year delays are possible due to some surprising events or, for example, the need to make modifications in the drug.

I remember Autifony's AUT00063 drug from some years ago, it was a very hot discussion topic on Tinnitus Talk and it looked very promising. Then it failed.

But it's so exciting to see the advances in the hearing research field these days.

There is also a new webcast available from today's Frequency Therapeutics presentation at Oppenheimer Virtual Fall Healthcare Life Sciences & MedTech Summit:

https://investors.frequencytx.com/e...-fall-healthcare-life-sciences-medtech-summit

At 32:00 Carl LeBel is again explaining their multiple injections with the hope to bring FX-322 "deeper" in the cochlea.

At 34:00 Carl LeBel is telling about monitoring tinnitus in the trial.

 

[tommyd87]

Does it, though? We have yet to hear first hand accounts from tinnitus sufferers. Look, I AM optimistic, but I'm not treating this as a done-deal. I mean, even Neuromod had glossy video testimonials. I've learned to be more guarded.

You could also say that the level of difficulty is much greater to regenerate tissue than to biohack the brain into no longer false-firing ringing noises. Rationalize onward as you will.

I think that there are three parts to your post worth addressing.

Firstly, I agree at this point it is not a done deal. However, there has been a lot of positive intel released so far that shows the method, FX-322 and also the limited results to date are promising. I feel that the fact these results were achieved shows that there has been a benefit from FX-322. I cannot see how you can get improvement and then dispute the effectiveness of FX-322 when no evidence has been established to show that this improvement was from another source.

Secondly, the reality is that FX-322 might not be the cure for tinnitus that people are claiming it is going to be. Yes, it has improved the tinnitus in some individuals based off of these anecdotal accounts announced. However, there is also the view that the tinnitus might be caused by busted synapses. Since the evidence suggests that while FX-322 treats synapses, it doesn't do this as completely as a synapse medication will. Therefore, if synapses are the cause of tinnitus, then this will mean that FX-322 is not the treatment for tinnitus.

Thirdly, it might be easier to biohack the brain than to try and actually develop medicine to treat tinnitus or other conditions. Currently though it appears that there is good evidence to suggest that biohacking the brain mightn't be as easy as actually some have claimed it to be.

 

[Diesel]

To anyone griping or acting skeptical about FX-322 treating tinnitus in a positive way... Frequency Therapeutics has gotten so loose about the fact that they've received first-hand testimonials about tinnitus improving for patients that got 1 dose in the Phase 1/2.

1. They can't keep repeating this as a publicly-traded company if it is a lie. Lawsuits would ensue.
2. The patients involved in the Phase 1/2 and Long-term study are probably still under a confidentiality agreement.
3. The patients may not want their identity revealed. IMAGINE the crash of tinnitus sufferers exploding your every inbox.
4. It's in the Phase 2A. The TFI is there for a reason.

FINALLY, have you all not listed to the very podcast produced by this forum? It's been about a month since I quoted this... but Carl LeBel said it here first... FX-322 seems to help tinnitus... on a tinnitus podcast:

From Episode 12: Hearing Lost and Found — Frequency Therapeutics:

"... there is anecdotal reports as patients have come back and visited with ENTs when they have had conversations with them about how they are doing. Some of them have offered that they have had improvements in tinnitus, there's nothing that we can quantitate there. Again, it adds to the excitement of the opportunity. "

- Carl LeBel, Frequency Therapeutics

FX-322 works as intended. It clearly treats noise-induced / sensorineural hearing loss related tinnitus. We will know to what extent when the Phase 2A ends. I hope it's a lot, so this debate is put to rest.

FINALLY: Frequency's willingness to be transparent (good, neutral, bad) on the data they continue to provide on a regular basis re: trials, treatments, progress is a good sign this company has a legitimate product. I have yet to see them dodge questions, omit data, do any type of reversal on anything. This should give a lot of investors and potential patients of this drug a lot of confidence.

*MIC DROP*

 

[tommyd87]

It probably would come out in 2026-2027 without Fast Track and 2023-2024 with Fast Track.

It could be even sooner than that. The question is really right now about what results they will see from the phase 2a trial.

Also another key piece of information is going to be how quickly can they improve the dosing if they need to do so.

Something says that they will get the initial treatment on the market ASAP if it is looking positive and as a result work out how to improve the treatment down the track if they in fact need to do so.

 

[FGG]

To anyone griping or acting skeptical about FX-322 treating tinnitus in a positive way... Frequency Therapeutics has gotten so loose about the fact that they've received first-hand testimonials about tinnitus improving for patients that got 1 dose in the Phase 1/2.

1. They can't keep repeating this as a publicly-traded company if it is a lie. Lawsuits would ensue.
2. The patients involved in the Phase 1/2 and Long-term study are probably still under a confidentiality agreement.
3. The patients may not want their identity revealed. IMAGINE the crash of tinnitus sufferers exploding your every inbox.
4. It's in the Phase 2A. The TFI is there for a reason.

FINALLY, have you all not listed to the very podcast produced by this forum? It's been about a month since I quoted this... but Carl LeBel said it here first... FX-322 seems to help tinnitus... on a tinnitus podcast:

From Episode 12: Hearing Lost and Found — Frequency Therapeutics:

"... there is anecdotal reports as patients have come back and visited with ENTs when they have had conversations with them about how they are doing. Some of them have offered that they have had improvements in tinnitus, there's nothing that we can quantitate there. Again, it adds to the excitement of the opportunity. "

- Carl LeBel, Frequency Therapeutics

FX-322 works as intended. It clearly treats noise-induced / sensorineural hearing loss related tinnitus. We will know to what extent when the Phase 2A ends. I hope it's a lot, so this debate is put to rest.

FINALLY: Frequency's willingness to be transparent (good, neutral, bad) on the data they continue to provide on a regular basis re: trials, treatments, progress is a good sign this company has a legitimate product. I have yet to see them dodge questions, omit data, do any type of reversal on anything. This should give a lot of investors and potential patients of this drug a lot of confidence.

*MIC DROP*

Has it been a whole week again already?

 

[FGG]

It probably would come out in 2026-2027 without Fast Track and 2023-2024 with Fast Track.

That's probably right on the money: current trial finishes soon. Then they start enrolling in their pivotal trial by 2nd half of 2021. That trial takes about 1 - 1.5 years, then read out and NDA submission. The NDA would get a response within 6 months since they are Fast Tracked.

That puts earliest 1st half of 2023, latest 1st half of 2024 unless the pivotal trial fills very, very quickly (which is maybe possible if it has many international sites too) and the pivotal trial only takes 8 to 9 months.

The wild card would be if they put production in gear early enough to start offering compassionate use before then.

 

[tommyd87]

That's probably right on the money: current trial finishes soon. Then they start enrolling in their pivotal trial by 2nd half of 2021. That trial takes about 1 - 1.5 years, then read out and NDA submission. The NDA would get a response within 6 months since they are Fast Tracked.

That puts earliest 1st half of 2023, latest 1st half of 2024 unless the pivotal trial fills very, very quickly (which is maybe possible if it has many international sites too) and the pivotal trial only takes 8 to 9 months.

The wild card would be if they put production in gear early enough to start offering compassionate use before then.

Here are some questions or clarifications, if you can help?

1. Phase 3 is the pivotal phase? If that is the pivotal phase, would they need to run a phase 2b trial prior to this or can they skip it and go straight to the phase 3 trial?

2. Can Frequency Therapeutics run a US clinical trial and also attain FDA approval with overseas participants? I am not sure how this actually works.

3. Can Frequency Therapeutics change the participant criteria in the pivotal trial or are they bound by the rules that have been established in the earlier clinical trials?

4. Those clinical trials that Frequency Therapeutics was going to run on the side of the main FDA trials do not have any influence on the FDA clinical trial, correct?

Also at this stage I think that the timeline that has been established by @paul mclean and yourself seems somewhat feasible. I think that there is a likelihood that compassionate use access being granted could potentially also be affected by the drug delivery/dosing. If Frequency Therapeutics can obtain better results from either a new delivery method or from their multiple dosing theory then I could see them push for compassionate use release much faster. From what I can understand, this is why Frequency Therapeutics is very focused on improving the dosing/delivery method.

 

[vttbx]

There is also a new webcast available from today's Frequency Therapeutics presentation at Oppenheimer Virtual Fall Healthcare Life Sciences & MedTech Summit:

https://investors.frequencytx.com/e...-fall-healthcare-life-sciences-medtech-summit

At 32:00 Carl LeBel is again explaining their multiple injections with the hope to bring FX-322 "deeper" in the cochlea.

At 34:00 Carl LeBel is telling about monitoring tinnitus in the trial.

Anyone else having trouble getting this video to play?

 

[tomytl]

It could be even sooner than that. The question is really right now about what results they will see from the phase 2a trial.

Also another key piece of information is going to be how quickly can they improve the dosing if they need to do so.

Something says that they will get the initial treatment on the market ASAP if it is looking positive and as a result work out how to improve the treatment down the track if they in fact need to do so.

Let's speculate that FX-322 gets FDA approval by 2025.

How long would it take for Frequency Therapeutics to then make it available in the commercial market?

I mean, it might take some time to figure out prices, distribution, and...

What can we expect?

 

[Lucifer]

Here are some questions or clarifications, if you can help?

1. Phase 3 is the pivotal phase? If that is the pivotal phase, would they need to run a phase 2b trial prior to this or can they skip it and go straight to the phase 3 trial?

2. Can Frequency Therapeutics run a US clinical trial and also attain FDA approval with overseas participants? I am not sure how this actually works.

3. Can Frequency Therapeutics change the participant criteria in the pivotal trial or are they bound by the rules that have been established in the earlier clinical trials?

4. Those clinical trials that Frequency Therapeutics was going to run on the side of the main FDA trials do not have any influence on the FDA clinical trial, correct?

Also at this stage I think that the timeline that has been established by @paul mclean and yourself seems somewhat feasible. I think that there is a likelihood that compassionate use access being granted could potentially also be affected by the drug delivery/dosing. If Frequency Therapeutics can obtain better results from either a new delivery method or from their multiple dosing theory then I could see them push for compassionate use release much faster. From what I can understand, this is why Frequency Therapeutics is very focused on improving the dosing/delivery method.

I remember someone saying that it does not matter if it's Phase 2b or Phase 3 next.

Pivotal stage means final phase before releasing it if it is approved by the FDA.

 

[Billy_Shears]

Let's speculate that FX-322 gets FDA approval by 2025.

How long would it take for Frequency Therapeutics to then make it available in the commercial market?

I mean, it might take some time to figure out prices, distribution, and...

What can we expect?

Frequency Therapeutics has a strategic partnership with Astellas in the development and deployment of FX-322 onto world markets. You can rest assured that all the specifics that go into marketing and accessibility of this drug to millions of individuals are concurrently being worked out. The company has also noted the ease of manufacturing this drug through standard methodical practices.

Carl LeBel has mentioned the fact that it will take many partners in the field to make this happen successfully, Frequency Therapeutics cannot in any way do all of this on their own. The $42 million private placement that Frequency Therapeutics received in mid August speaks volumes - investors liked the answers to their questions and they liked what they have seen up to this date. The private placement can be looked upon as the pathway to the market.

 

[Diesel]

Carl LeBel mentioned in the HLAA video that depending on the Phase 2A data, if it is promising, they may consider the next phase the pivotal phase.

One big open question is whether or not FX-322 gains Breakthrough Therapy status. If the results of the Phase 2A continue to look as good, or better than the Phase 1/2, it would qualify for Breakthrough Therapy status according to the FDA.

Technically, drug manufacturers can begin manufacturing the drug BEFORE the FDA grants approval.

I have a hard time seeing FDA approval being as far out as 2025.

 

[Diesel]

Here are some questions or clarifications, if you can help?

1. Phase 3 is the pivotal phase? If that is the pivotal phase, would they need to run a phase 2b trial prior to this or can they skip it and go straight to the phase 3 trial?

2. Can Frequency Therapeutics run a US clinical trial and also attain FDA approval with overseas participants? I am not sure how this actually works.

3. Can Frequency Therapeutics change the participant criteria in the pivotal trial or are they bound by the rules that have been established in the earlier clinical trials?

4. Those clinical trials that Frequency Therapeutics was going to run on the side of the main FDA trials do not have any influence on the FDA clinical trial, correct?

Also at this stage I think that the timeline that has been established by @paul mclean and yourself seems somewhat feasible. I think that there is a likelihood that compassionate use access being granted could potentially also be affected by the drug delivery/dosing. If Frequency Therapeutics can obtain better results from either a new delivery method or from their multiple dosing theory then I could see them push for compassionate use release much faster. From what I can understand, this is why Frequency Therapeutics is very focused on improving the dosing/delivery method.

1. Phase 3 or Phase 2b can be considered Pivotal. If Phase 2A meets endpoints in a statistically significant way to Frequency Therapeutics, they can decide what to do next.

2. The FDA may consider the results obtained from studies done abroad; as long as the studies comply with FDA regulations. Nearly all developed countries meet these regulatory requirements. I'm sure Astellas would work with non-US countries that meet these requirements, otherwise it would be a waste of money/time.

3. They can choose to expand the participant criteria in the Phase 3, and the primary and secondary outcomes. Generally, they're looking for side effects. So we may see a larger spectrum of hearing loss candidates getting similar random dosing. However, Frequency Therapeutics could opt in the Phase III to create classification groups, IE: a Mild, Moderate, Severe class that is then each broken into a 1X, 2X, 4X, Placebo group. Which would give them 12 series of patient data. They have also discussed testing in BOTH ears in the pivotal phase; which would offer an entirely new set of data.

4. I believe the other studies (Perilymph and Long-Term) would qualify as Non-Clinical Studies to the FDA. It is not clear whether or not they would apply to the IND. There seems to be some ambiguity; but from what I can tell, it may be regarded as peripheral data.

 

[tommyd87]

1. Phase 3 or Phase 2b can be considered Pivotal. If Phase 2A meets endpoints in a statistically significant way to Frequency Therapeutics, they can decide what to do next.

2. The FDA may consider the results obtained from studies done abroad; as long as the studies comply with FDA regulations. Nearly all developed countries meet these regulatory requirements. I'm sure Astellas would work with non-US countries that meet these requirements, otherwise it would be a waste of money/time.

3. They can choose to expand the participant criteria in the Phase 3, and the primary and secondary outcomes. Generally, they're looking for side effects. So we may see a larger spectrum of hearing loss candidates getting similar random dosing. However, Frequency Therapeutics could opt in the Phase III to create classification groups, IE: a Mild, Moderate, Severe class that is then each broken into a 1X, 2X, 4X, Placebo group. Which would give them 12 series of patient data. They have also discussed testing in BOTH ears in the pivotal phase; which would offer an entirely new set of data.

4. I believe the other studies (Perilymph and Long-Term) would qualify as Non-Clinical Studies to the FDA. It is not clear whether or not they would apply to the IND. There seems to be some ambiguity; but from what I can tell, it may be regarded as peripheral data.

1. Thanks, that clears it up for me what the meaning of a pivotal trial is.

2. I didn't know if FDA recognised clinical trials abroad officially, however I thought that they might since there tends to be agreements between the FDA and other countries' pharmaceutical regulators.

3. Well explained, thanks.

4. I was actually referring to those side studies/trials that Frequency Therapeutics was wanting to engage in, such as the older population.

 

[all to gain]

I presume there are forces out there, i.e. interested parties like the hearing aid industry, that will do everything in their power to make sure FX-322 doesn't hit the market, or if it does, to make sure it fails somehow.

What theoretically could they do to achieve their goal?

 

[paul mclean]

@all to gain All they could do is talk shit on FX-322 and say it doesn't work and people don't get benefits from it.

Once the cat's out of the bag they are done. They will still have a fairly large market as hearing aids are needed for congenital hearing loss but the majority of hearing loss is acquired so FX-322, assuming it works and hits the market, will almost immediately take 70% of the hearing aid market away from the hearing aid companies.

They won't be happy about it but it's guaranteed they all knew one day this would happen and they would have made marketing strategies to maximize profits before their D-Day.

 

[aot]

I presume there are forces out there, i.e. interested parties like the hearing aid industry, that will do everything in their power to make sure FX-322 doesn't hit the market, or if it does, to make sure it fails somehow.

What theoretically could they do to achieve their goal?

That possibilty has always been in the back of my mind. Very worried about that.

 

[d'Wooluf]

I presume there are forces out there, i.e. interested parties like the hearing aid industry, that will do everything in their power to make sure FX-322 doesn't hit the market, or if it does, to make sure it fails somehow.

What theoretically could they do to achieve their goal?

Nothing. Even if they bought up FREQ shares with the aim of shutting them down, I'm pretty sure that the license to the IP from MIT/Harvard stipulated milestones. If Frequency Therapeutics didn't progress the technology, they would probably lose the license and the IP would revert to MIT/Harvard who could then spin it off wherever they wanted to.

Plus there are labs and startups all over the world... they couldn't shut them all down.

 

[d'Wooluf]

Once the cat's out of the bag they are done.

Unless we see a large improvement on the 10 dB threshold shift at 8 kHz, those of us who wear hearing aids now will still need hearing aids. If anything it might move people into that zone where hearing aids can actually do some good.

 

[MikeAMFM]

I inquired if I was eligible for the FX-322 clinical trials.

Got this back in reply. I am going to see if I can send an audiogram in to see if I qualify... I should as I had Cisplatin done years ago and for sure SNHL is a co-factor along with probable allergy triggers... weight loss... recent surgery... etc.


Their response below:

Greetings

Thank you for your inquiry regarding the FX-322 Clinical Study. All sites are no longer recruiting as of today.

WOBURN, Mass.--(BUSINESS WIRE)--Sep. 22, 2020-- 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 the completion of enrollment of its Phase 2a study of FX-322 for sensorineural hearing loss (SNHL). The company anticipates obtaining full results for the study, in which 95 patients were enrolled, in the second quarter of 2021.

Please continue to follow us here for updates in the future:

https://investors.frequencytx.com/news-releases

Regards, Clinical Trials Information

 

[NewLionel]

Anyone else thinking about freezing themselves until FX-322 comes out? Might be the smart/easiest option.