Frequency Therapeutics — Hearing Loss Regeneration

[tbuzz89]

I just don't want to risk the fact that I know I'll need more then one injection and won't know if I can get into a future study because I've participated in the single injection one.

Believe me, I understand the fear you're experiencing but the next possible trial you could enter in for FX-322 would be Phase 3. Even if you only received one injection during that trial, the hope is that approval will be the next "phase" and thus you'll be able to receive subsequent injections (if needed) by your ENT upon the full release of the medicine.

I'm for sure going to apply for the Phase 3 trials despite whatever unconfirmed information we hear either on Tinnitus Talk or elsewhere. Even if I only receive a placebo and garner no positive effects because of that, my participation helped the greater study. Then when the medicine is released, I'll get the real thing.

 

[FGG]

I wonder what happens to the dead hair cells in the cochlea once FX-322 is administered?

Do the new hair cells replace them or are the dead hair cells still there and the new hair cells are just grown around them?

If the new hair cells replace the old ones, then that would be good I think.

In the Tinnitus Talk Podcast, Carl LeBel said there weren't supernummery cells which means they were either already cleared by the body or displaced (and then cleared). It doesn't seem like an issue.

 

[Bill Arsenault]

NDAs have a place in court when the signee does something like try to profit, gain notoriety, or discredit the institution on the other end of the agreement. For example, if a participant of an FX-322 trial tried to get some personal publicity on the trial by being interviewed by the media, or received payment in exchange for their experience in the trial; by telling people that it worked miracles for them, or was a scam. These situations would be where an NDA could be enforced in a court and the institution may be able to receive damages or a judge-ordered gag. There would need to be evidence that the signee intentionally broke the NDA to make a gain (usually financial) at the expense of the institution.

I doubt Frequency Therapeutics would go through all this expensive and time-consuming trouble for a few lay-people talking about the drug on social media; even if social media discussion about the trial was banned in the NDA.

Give it up already.

Are you really going to attempt to justify breaking a promise to keep a secret with legal jargon?

You talked non-sense and got called out.
Own it.

Just because someone has no recourse does not mean it's ok to burn them.
I hope you don't have kids man.

I doubt this - and I'll be shocked by that -
Whatever.

People should not be re-posting content from broken Frequency Therapeutics NDAs on this forum.
It's a bad look that is completely unnecessary at this point.

If you do it then you are going to be ruthlessly insulted by me every time.
If you cannot keep your word and be loyal then don't make promises.
You get stabbed in the face for that where I grew up.

 

[Fields]

Like I've mentioned before and like you are stating, I don't think the loss of dBs in an audiogram is what mainly matters to the volume of one's tinnitus. I think it depends on how quickly that loss is acquired. A sudden trauma has a higher likelihood of causing tinnitus than a slightly loud enough to be damaging noise over a longer period of time. Only my uneducated guess though.

I recently had an extended audiogram taken, including several other tests. As it turns out, my hearing is exceptionally good across all frequencies. I've been taking extremely good care of my ears since a young age, which might explain the results.

Even so, my tinnitus and hyperacusis started after my first experience with acoustic shock. Taking my audiogram into account, I suppose busted synapses are more likely to be the cause of my tinnitus.

So, as it turns out, FX-322 likely won't be that helpful for me*. Nevertheless, I'm keeping a keen eye on its development. A successful release of this treatment, and positive results among sufferers of tinnitus, would be a great stride forward.

*Naturally, depending on future results and/or possible drawbacks, I'd still like to try it if it were to become available to me.

 

[Street Novelist]

So far results have been looking good but we need to find out more in March and May to see whether patients who have received additional doses of FX-322 improved a lot compared to those who got 3 doses of FX-322 or less. I do hope when the results are positive in March and May that they open up compassionate use or being able to release the drug into the market after Phase 2a.

Completely agree... If the results are what we think they are, I hope they just don't release the results in March and do nothing. That would be a complete waste of 2021. We already know what the results are going to look like, barring some strange revelation.

I really hope the FDA does something. That, I think, is what it all comes down to: the FDA.

 

[tiredofit]

I'm for sure going to apply for the Phase 3 trials despite whatever unconfirmed information we hear either on Tinnitus Talk or elsewhere. Even if I only receive a placebo and garner no positive effects because of that, my participation helped the greater study. Then when the medicine is released, I'll get the real thing.

How does one apply?

 

[Lucifer]

Completely agree... If the results are what we think they are, I hope they just don't release the results in March and do nothing. That would be a complete waste of 2021. We already know what the results are going to look like, barring some strange revelation.

I really hope the FDA does something. That, I think, is what it all comes down to: the FDA.

I stated in an earlier post that I hope the FDA consider hearing loss, tinnitus and hyperacusis as life altering conditions and be lenient towards FX-322 if it has shown positive results to resolve these conditions and hopefully be able to release it after the Phase 2a clinical trial is done.

 

[Princebeyel]

Believe me, I understand the fear you're experiencing but the next possible trial you could enter in for FX-322 would be Phase 3. Even if you only received one injection during that trial, the hope is that approval will be the next "phase" and thus you'll be able to receive subsequent injections (if needed) by your ENT upon the full release of the medicine.

I'm for sure going to apply for the Phase 3 trials despite whatever unconfirmed information we hear either on Tinnitus Talk or elsewhere. Even if I only receive a placebo and garner no positive effects because of that, my participation helped the greater study. Then when the medicine is released, I'll get the real thing.

What about Phase 2b for severe hearing loss?

 

[frpp]

What about Phase 2b for severe hearing loss?

From how it sounds, it's likely Phase 2b will be combined with Phase 3.

 

[Diesel]

I stated in an earlier post that I hope the FDA consider hearing loss, tinnitus and hyperacusis as life altering conditions and be lenient towards FX-322 if it has shown positive results to resolve these conditions and hopefully be able to release it after the Phase 2a clinical trial is done.

The Fast Track Designation for FX-322 is an acknowledgement from the FDA that sensorineural hearing loss is a serious and/or life altering condition. Tinnitus and hyperacusis aren't underlying conditions, but symptoms of SNHL. Positive data on the TFI in the experimental arm of the Phase 2A and both Phase 1Bs will certainly be factored into consideration by the FDA for next steps.

Unfortunately, there aren't academically/clinically accepted ways to measure hyperacusis; so the FDA won't have a good way to measure improvements of the symptoms. We won't know if FX-322 treats hyperacusis until after it's on the market.

 

[Lucifer]

The Fast Track Designation for FX-322 is an acknowledgement from the FDA that sensorineural hearing loss is a serious and/or life altering condition. Tinnitus and hyperacusis aren't underlying conditions, but symptoms of SNHL. Positive data on the TFI in the experimental arm of the Phase 2A and both Phase 1Bs will certainly be factored into consideration by the FDA for next steps.

Unfortunately, there aren't academically/clinically accepted ways to measure hyperacusis; so the FDA won't have a good way to measure improvements of the symptoms. We won't know if FX-322 treats hyperacusis until after it's on the market.

I do hope the Breakthrough Therapy status will speed up the clinical trials for FX-322. If we are lucky it may be out of the market after Phase 2a trials are completed but if not, definitely after Phase 2b/3 clinical trials are completed.

 

[100Hz]

Do trials typically offer to treat the trial participants who receive partial or full placebo, in full, if and once the treatment is approved? (Top up the doses they didn't get). Or do they have to get in line and pay in full for it?

 

[Princebeyel]

From how it sounds, it's likely Phase 2b will be combined with Phase 3.

What makes you believe this?

 

[Diesel]

Do trials typically offer to treat the trial participants who receive partial or full placebo, in full, if and once the treatment is approved? (Top up the doses they didn't get). Or do they have to get in line and pay in full for it?

From my own research, it seems about 50/50 where a post-trial provision is made available for participants that got placebo to get the real thing. Usually though this is for patients that need the drug to keep living.

 

[FGG]

What makes you believe this?

They said in the Tinnitus Talk Podcast that they plan for the next trial to be "pivotal" meaning the final one before they apply for approval. A combined Phase 2b/3 fits that criteria.

 

[tommyd87]

Completely agree... If the results are what we think they are, I hope they just don't release the results in March and do nothing. That would be a complete waste of 2021. We already know what the results are going to look like, barring some strange revelation.

I really hope the FDA does something. That, I think, is what it all comes down to: the FDA.

I think that COVID-19 coupled with the fact that there tends to be lawmakers from both sides of the US political spectrum is actually going to rework and change the way which we see the FDA look at approving a medicine/treatment. The thing that COVID-19 has shown a lot of people is what the need and benefit of functional medicine is to treat or vaccinate against something thanks to the unfortunate consequences of the pandemic.

Although I believe that some exceptions are being granted to those that have developed vaccinations and some relaxations of the requirements have been enabled due to the extrordinary situation of the pandemic, I think that there has been a recognition that there's a need to get medicines out more quickly and without needing to pass so many hurdles if it is reasonable and safe to do so. Stuff like the Promising Pathway law is harnessing and instigating this sort of thing too and indicates a desire to implement and consider a much more common sense and much more reasonable approach to medicine approvals when possible.

 

[FGG]

From my own research, it seems about 50/50 where a post-trial provision is made available for participants that got placebo to get the real thing. Usually though this is for patients that need the drug to keep living.

I asked this about FX-322 when I applied and she said they were not offering the drug after the trial to those who got placebo.

It's possible they would in the next trial though since they would already have to ramp up production a bit for the bigger trial (assuming that was a factor).

 

[FGG]

How does one apply?

Check ClinicalTrials.gov for updates. Once they announce the trial locations (announced on the site), contact the one closest to you.

 

[Gb3]

They said in the Tinnitus Talk Podcast that they plan for the next trial to be "pivotal" meaning the final one before they apply for approval. A combined Phase 2b/3 fits that criteria.

Well then wouldn't this latest trial be the "next trial"?

 

[Ozwel]

Agreed with FGG. We have nothing to win except short-lived happiness. Let's wait for official statements in March.

It's only a season away

 

[Lucifer]

If Compassionate Use was granted for FX-322, would they still give you placebo or give you the real drug?

 

[FGG]

Well then wouldn't this latest trial be the "next trial"?

The Tinnitus Talk Podcast happened during this current trial, so they meant one following this one.

 

[Philip83]

Regarding delivery - This seems to be the main hurdle for Frequency Therapeutics to improve on at the moment, correct? Sure, there might be other reasons why FX-322 is working "better" in a lab setting than in humans, but surely there's a good chance that results will improve if the delivery method is improved.

I remember Carl LeBel saying something in the Tinnitus Talk Podcast about them looking heavily into different delivery methods. I haven't read or heard much about this elsewhere though. Is there any more info out there on their approach on this? What other delivery methods are they potentially exploring? Could it be anything else than injections, and/or can the type of gel and/or type of injection be improved somehow? Could this be something they can improve on in Phase 3 for example, or would they have to restart at a Phase 1?

Sorry, just blaring out questions here in hopes someone has a clue...

 

[Diesel]

Regarding delivery - This seems to be the main hurdle for Frequency Therapeutics to improve on at the moment, correct? Sure, there might be other reasons why FX-322 is working "better" in a lab setting than in humans, but surely there's a good chance that results will improve if the delivery method is improved.

I remember Carl LeBel saying something in the Tinnitus Talk Podcast about them looking heavily into different delivery methods. I haven't read or heard much about this elsewhere though. Is there any more info out there on their approach on this? What other delivery methods are they potentially exploring? Could it be anything else than injections, and/or can the type of gel and/or type of injection be improved somehow? Could this be something they can improve on in Phase 3 for example, or would they have to restart at a Phase 1?

Sorry, just blaring out questions here in hopes someone has a clue...

The current drug with delivery method will have to go forward as is to Phase 3 and to market.

A new delivery method, whether it's a better gel, a different procedure, or something else, will need a new set of trials. It will depend on the method.

If it's just a new gel with the same FX-322 that's injected the same way, should be short.

If it's a completely new procedure. The procedure itself may need independent trials first, then a potential reformulation of the drug may be needed on top of that.

 

[FGG]

Regarding delivery - This seems to be the main hurdle for Frequency Therapeutics to improve on at the moment, correct? Sure, there might be other reasons why FX-322 is working "better" in a lab setting than in humans, but surely there's a good chance that results will improve if the delivery method is improved.

I remember Carl LeBel saying something in the Tinnitus Talk Podcast about them looking heavily into different delivery methods. I haven't read or heard much about this elsewhere though. Is there any more info out there on their approach on this? What other delivery methods are they potentially exploring? Could it be anything else than injections, and/or can the type of gel and/or type of injection be improved somehow? Could this be something they can improve on in Phase 3 for example, or would they have to restart at a Phase 1?

Sorry, just blaring out questions here in hopes someone has a clue...

We don't know how much of a hurdle it is yet as repeat dosing should lend to deeper penetrance (as LeBel alluded to in the Tinnitus Talk Podcast).

So solving the problem could be as simple as frequent dosing or may require something like reformulation. That's one of the things Phase 2a is trying to work out.

 

[Ben Winders]

I'm sure this has been answered before but why are they excluding subjects with 15 dB hearing loss from the trials?

Here in Belgium 20 dB at 4000 Hz is still considered a normal audiogram. No hearing loss.

I'm sure I'm interpreting this 15 dB wrong.

Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear at the Screening visit or on the prior audiogram (if the Investigator feels there is not a true conductive hearing loss, the Medical Monitor should be consulted).

 

[FGG]

I'm sure this has been answered before but why are they excluding subjects with 15 dB hearing loss from the trials?

Here in Belgium 20 dB at 4000 Hz is still considered a normal audiogram. No hearing loss.

I'm sure I'm interpreting this 15 dB wrong.

Conductive loss is a specific kind of hearing loss (shows up as an air bone gap on audiogram). This exclusion concerns conductive loss only.

 

[Gb3]

The Tinnitus Talk Podcast happened during this current trial, so they meant one following this one.

The new trial for age-related hearing loss that started in October? Or does that not qualify as a trial?

 

[Ben Winders]

Conductive loss is a specific kind of hearing loss (shows up as an air bone gap on audiogram). This exclusion concerns conductive loss only.

Got it! Appreciate you taking the time to clarify.

 

[FGG]

The new trial for age-related hearing loss that started in October? Or does that not qualify as a trial?

When he referred to Frequency Therapeutics hoping the next trial was a pivotal trial, he was referring to the main ongoing trial. The trials for other indications may help a larger enrollment for Phase 3 / Phase 2b/3 but wouldn't be pivotal.

The pivotal trial has not been announced yet.