Frequency Therapeutics — Hearing Loss Regeneration

[Lucifer]

They are conducting a tinnitus assessment during this phase. Is there anything that would lead us to believe they won't be disclosing a part of that information in March/May?

I think they will disclose about tinnitus in March since it was tested so can't wait for that. The long wait is killing me.

 

[Princebeyel]

Is there any upside to the company to grant compassionate use?

I feel like it's just an asymmetrical risk/reward - they release something that could have unknown side effects early, and the reward is... they get some money from you for treatment that they would presumably have captured anyway? I guess it would generate some positive press but realistically that's also something they could generate without compassionate use - a successful product would be revolutionary - no need to rush things.

I try not to forget they have a fiduciary obligation to their investors and expect them to act accordingly...

The upside would be helping the millions of people suffering from hearing loss IMO. Isolation and not wanting to live anymore.

 

[tommyd87]

So does them going to Phase 3 mean that they can't apply for compassionate release next year if they decide to take that road?

As I was really hoping that I wouldn't have to wait for multiple years before at least being able to try it, and an early release along those grounds would really mean something to me...

I don't think we can really come to any conclusions about their potential plans for compassionate use based on this. This was overall a 5-10 minute interview so I don't think it's cause for alarm that he didn't bring it up. Carl LeBel didn't rule it out in his Tinnitus Talk Podcast interview and said they would possibly be open to it once we have further data.

The fact of the matter is that they need to go to phase 3 regardless of whether they want to grant compassionate use or not since the FDA requires this. Therefore I agree that it is too challenging to rule things in or out based on this commentary from Christopher Loose.

 

[dan]

Is there any upside to the company to grant compassionate use?

3 months in, you want compassionate use already? joking.

 

[Bill Arsenault]

Probably self-evident.

But I hope it does not hurt to remind people that even if this drug has some effect on tinnitus that everyone will more than likely have vastly different experiences
relative to what it does for their ears -
at every severity level and at both ends of the recovery spectrum.

I have to say that I very much like the thought of it ending up being either better for tinnitus and for the hyperacusis sufferers than it is for anything else or for it to at least be the direct pre-cursor to a treatment specifically for tinnitus.

Almost impossible to imagine that this all goes nowhere for tinnitus sufferer s-
My tummy is getting sick just thinking about that prospect.
This thread is actually terrifying sometimes.


Hope everyone enjoys the Holiday.

 

[Jack V]

Trying not to overthink it either but it's definitely a confident and notable statement. His statement is only as it applies to hearing loss results, not tinnitus. Really hoping that the 90 day results in March include more substantial information regarding effects on tinnitus.

Success with hearing loss IS success with tinnitus...

 

[Diesel]

The upside would be helping the millions of people suffering from hearing loss IMO. Isolation and not wanting to live anymore.

Compassionate use isn't intended to treat millions of people. The volume of demand would be unmanageable, and maybe unprofitable, and potentially a liability for Frequency Therapeutics. Helping millions with a mass-volume product is what the final, FDA approved product is intended to do.

 

[tommyd87]

Compassionate use isn't intended to treat millions of people. The volume of demand would be unmanageable, and maybe unprofitable, and potentially a liability for Frequency Therapeutics. Helping millions with a mass-volume product is what the final, FDA approved product is intended to do.

Isn't this what the Promising Pathway legislation is supposed to enable though? The companies get certainty that the medicine will most likely pass FDA requirements and consumers can obtain use of the medicine early?

 

[Diesel]

Isn't this what the Promising Pathway legislation is supposed to enable though? The companies get certainty that the medicine will most likely pass FDA requirements and consumers can obtain use of the medicine early?

Promising Pathway Act, YES. It would allow for provisional approval of drugs that show high efficacy and favorable safety; as long as there is a plan by the sponsor to continue a Phase 3 + Application for approval over (I believe) the next 5 years. We can assume FX-322 has a favorable safety profile, as the Phase 2A has not been halted; and hopefully the efficacy from the Phase 1/2 is retained or improves.

HOWEVER: That is a bill currently sitting in a dysfunctional US legislature, particularly the Senate. So, it won't even move to the current President's desk until after Jan 20, 2021. Even then, this bill may not be a priority of the Biden administration for any time in 2021. Even if it were signed into law given all the other priorities, I don't expect its impact to hit the FDA and current trials until 2022. By then, FX-322 may already be in Phase 3, so it seems pointless to hang our hats on Promising Pathways.

Breakthrough Status in 2021 is by-far the best option to maximize the speed for FX-322 to hit the market.

 

[Lucifer]

Promising Pathway Act, YES. It would allow for provisional approval of drugs that show high efficacy and favorable safety; as long as there is a plan by the sponsor to continue a Phase 3 + Application for approval over (I believe) the next 5 years. We can assume FX-322 has a favorable safety profile, as the Phase 2A has not been halted; and hopefully the efficacy from the Phase 1/2 is retained or improves.

HOWEVER: That is a bill currently sitting in a dysfunctional US legislature, particularly the Senate. So, it won't even move to the current President's desk until after Jan 20, 2021. Even then, this bill may not be a priority of the Biden administration for any time in 2021. Even if it were signed into law given all the other priorities, I don't expect its impact to hit the FDA and current trials until 2022. By then, FX-322 may already be in Phase 3, so it seems pointless to hang our hats on Promising Pathways.

Breakthrough Status in 2021 is by-far the best option to maximize the speed for FX-322 to hit the market.

Wouldn't someone like Biden want to allow the Promising Pathway Act to be implemented especially to speed up the process for something like a COVID-19 vaccine and other vaccines for terminal conditions etc?

 

[Diesel]

Wouldn't someone like Biden want to allow the Promising Pathway Act to be implemented especially to speed up the process for something like a COVID-19 vaccine and other vaccines for terminal conditions etc?

Biden might. His current comments have been on vaccine manufacturing/distribution; which the FDA is giving emergency authorization for already. Promising Pathway might apply to treatments in the pipeline for those that are currently ill, but cannot receive a vaccine.

I don't see a Senate led by McConnell being helpful at all, which is really the core blocker to the bill in legislation.

 

[Lucifer]

Biden might. His current comments have been on vaccine manufacturing/distribution; which the FDA is giving emergency authorization for already. Promising Pathway might apply to treatments in the pipeline for those that are currently ill, but cannot receive a vaccine.

I don't see a Senate led by McConnell being helpful at all, which is really the core blocker to the bill in legislation.

Has this bill been proposed before and been blocked by Republicans in the US Senate?

 

[Gorbeh3]

MIT Scientist Bob Langer Becomes A Billionaire Thanks To Moderna Stock Rally

 

[Born To Slay]

Biden might. His current comments have been on vaccine manufacturing/distribution; which the FDA is giving emergency authorization for already. Promising Pathway might apply to treatments in the pipeline for those that are currently ill, but cannot receive a vaccine.

I don't see a Senate led by McConnell being helpful at all, which is really the core blocker to the bill in legislation.

Has this bill been proposed before and been blocked by Republicans in the US Senate?

Ya know guys, this bill would need 60 votes to pass. So regardless of whether the Dems or GOP wins the Senate in January, it's going to have to be bipartisan.

 

[Street Novelist]

I think our best bet is to hope for the Phase 3/Pivotal trial to start next year. I doubt we will see compassionate use. But if you can get in to the next trial, you are almost guaranteed the drug, without having to pay for it.

 

[Lucifer]

I think our best bet is to hope for the Phase 3/Pivotal trial to start next year. I doubt we will see compassionate use. But if you can get in to the next trial, you are almost guaranteed the drug, without having to pay for it.

The likelihood of any Tinnitus Talk member getting into the Phase 3 clinical trials is quite low. The only reason why someone would want compassionate use is because the clinical trials won't let them participate due to their criteria.

The people that should be getting FX-322 for compassionate use are those who suffer from hyperacusis or reactive tinnitus.

 

[Born To Slay]

I think our best bet is to hope for the Phase 3/Pivotal trial to start next year. I doubt we will see compassionate use. But if you can get in to the next trial, you are almost guaranteed the drug, without having to pay for it.

I think the real best bet is if it gets Breakthrough Therapy status and comes to market after Phase 2A is complete.

 

[tommyd87]

Has this bill been proposed before and been blocked by Republicans in the US Senate?

From what I remember from the post a few pages back where someone contacted their Senators to provide support for this bill, one was actually a Republican Senator from Indiana. I think that this bill probably would have bipartisan support. I can't see the Democrats under Biden rejecting positive and favourable health laws, especially with their position on COVID-19. Furthermore, I think that it is unlikely that you would not find around a dozen Republican senators to support this either.

 

[Princebeyel]

I think our best bet is to hope for the Phase 3/Pivotal trial to start next year. I doubt we will see compassionate use. But if you can get in to the next trial, you are almost guaranteed the drug, without having to pay for it.

I thought about getting into the severe hearing loss FX-322 trial. However, my concern is if I do, I won't be able to get into the future study which will give more shots of the FX-322 which I'm almost certain will be needed.

Any thoughts? I fear this because an exclusion of the criteria says no previous participants.

Also I don't mind paying for it. Whatever the cost, I just want my life back.

 

[sssing]

3 months in, you want compassionate use already? joking.

Sorry, I'm not sure what you mean?

 

[Jack V]

I thought about getting into the severe hearing loss FX-322 trial. However, my concern is if I do, I won't be able to get into the future study which will give more shots of the FX-322 which I'm almost certain will be needed.

Any thoughts? I fear this because an exclusion of the criteria says no previous participants.

Also I don't mind paying for it. Whatever the cost, I just want my life back.

I would think the bigger concern is, assuming FX-322 works, you're not sure you're getting the drug or a placebo.

Personally, I think I'd try to get in an earlier trial, hope I get the drug, hope the drug works, and see if it gives me *some* relief. And if it did, I'd know that eventually I'd have access to additional shots once the drug is released.

However, there are so many unknowns in trying to figure it out, I might just toss a coin.

 

[frpp]

From what I remember from the post a few pages back where someone contacted their Senators to provide support for this bill, one was actually a Republican Senator from Indiana. I think that this bill probably would have bipartisan support. I can't see the Democrats under Biden rejecting positive and favourable health laws, especially with their position on COVID-19. Furthermore, I think that it is unlikely that you would not find around a dozen Republican senators to support this either.

I can't see any sane politician not supporting this bill. If something has the ability to universally help people's health it shouldn't be a debate, it should be unanimous, period.

 

[NewLionel]

I can't see any sane politician not supporting this bill. If something has the ability to universally help people's health it shouldn't be a debate, it should be unanimous, period.

It should be unanimous but maybe someone might hold the passing of it hostage to allow for fracking in the Grand Canyon or something.

 

[TrevorSanders]

I can't see any sane politician not supporting this bill. If something has the ability to universally help people's health it shouldn't be a debate, it should be unanimous, period.

They'll find some way to make this a bipartisian issue.

 

[Lucifer]

I think the real best bet is if it gets Breakthrough Therapy status and comes to market after Phase 2A is complete.

I hope this is still possible as this is the best chance that all of us can get FX-322. Since they sped up the process on getting the COVID-19 vaccine out; I hope they consider releasing FX-322 ASAP.

 

[Diesel]

I hope this is still possible as this is the best chance that all of us can get FX-322. Since they sped up the process on getting the COVID-19 vaccine out; I hope they consider releasing FX-322 ASAP.

From the FDA website on Breakthrough Therapy Designation:

"Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy."

A serious condition...
Hearing loss is considered a serious condition by the FDA.

Significant improvement...
FX-322 has already shown significant improvements over "available therapy" at one clinically significant endpoint in the Phase 1/2: Word score.

So, in my opinion, it's already met the requirements, the Phase 2A data should just make it more convincing.

 

[NewLionel]

I hope this is still possible as this is the best chance that all of us can get FX-322. Since they sped up the process on getting the COVID-19 vaccine out; I hope they consider releasing FX-322 ASAP.

If it works, then it will make money, then it will get released quickly. Companies and politicians both love money. I also love money but I would love new/fixed ears more.

 

[dan]

I hope this is still possible as this is the best chance that all of us can get FX-322. Since they sped up the process on getting the COVID-19 vaccine out; I hope they consider releasing FX-322 ASAP.

Seriously are you comparing COVID-19 to tinnitus in terms of world caring about tinnitus?

 

[Koz]

My own concern is trying to keep my hearing loss in the moderately severe to severe range until this thing comes out (provided it works) and not having it slip into profound which is when there's not enough support cells for FX-322 to work.

I am doing everything I can to protect my hearing (something I started doing way too late), however, there's a finite level of control one can have after initial damage anyway and at the stage I'm at as well.

It's great there are other things potentially coming for profound cases but I'd really rather not slip into the profound range and for this drug to work and I don't have to wait for other things.

What I am also hopeful about is that if I do slip into profound in some ranges then this drug would still work and fix these profound ranges/frequencies based on the others that are still in severe ranges.

 

[Lucifer]

Seriously are you comparing COVID-19 to tinnitus in terms of world caring about tinnitus?

I would expect that since they sped up the process of getting the COVID-19 vaccine to come out that they show some leniency on getting other drugs that will help with terminal illness or life altering conditions as long as it has been shown to be safe and effective.

The world will never care about tinnitus till more people talk about the severity of these issues. From what Covid-19 has done, some people have gotten tinnitus from it and they will be suffering too. I hope FX-322 and other drugs still currently in clinical trials to be released ASAP to cure our conditions.