Frequency Therapeutics — Hearing Loss Regeneration

[papu]

Realistically, if this passes all phases of the trial, when can we expect this to be available commercially? I'm really struggling with tinnitus and it would be nice if it could be available sooner than later(as in not ten years from now..)

No one can truly say. It all depends on how well it goes in next the trial. This time they will also be checking how it works for tinnitus. If the results are mind bending and very successful i am positive that we will be seeing something in less than 3 years with fast tracking. If the results are not conclusive or only yields slight improvement, it will be a long road or not be made available at all. That's just an estimated guess.

 

[ChrisBoyMonkey]

Realistically, if this passes all phases of the trial, when can we expect this to be available commercially? I'm really struggling with tinnitus and it would be nice if it could be available sooner than later(as in not ten years from now..)

If all goes well, it definitely will be here before 10 years. Maybe even 2-3.

These guys aren't playing any games.

 

[Daniel Lion]

If all goes well, it definitely will be here before 10 years. Maybe even 2-3.

These guys aren't playing any games.

This is true... they are some of the best minds in this field on planet earth.

We are at the beginning of the regenerative medicine revolution. There will be hiccups, plateaus, failures and successes.

As desperate as we are, and I am desperate, we need to be "cautiously optimistic" as member d'wooluf said. That way we're not heartbroken and can work at living in the present. This is not aimed at CBM, but some words of chill for myself and some other comrades who are freaking out.

Stay cool comrades, one phase at a time, fingers crossed...

 

[RingingBrother]

Wait... So there was supposed to be phase 1b and they skipped it???

I think the FDA was giving Frequency Therapeutics some extra help even before fast track kicked in. It seems a cure for hearing loss is becoming a top priority because of the effect on the military and the economic loss caused by it is making it a national security issue which is why the DoD started funding hearing restoration research in 2017.

 

[RingingBrother]

Realistically, if this passes all phases of the trial, when can we expect this to be available commercially? I'm really struggling with tinnitus and it would be nice if it could be available sooner than later(as in not ten years from now..)

If it continues having no safety issues and passes efficacy maybe the FDA and the U.S Military will want it out by 2021.

 

[FGG]

If it continues having no safety issues and passes efficacy maybe the FDA and the U.S Military will want it out by 2021.

Interesting thought but if they really were preferentially picking test subjects with sudden noise related hearing loss maybe it would be because of something like this...

 

[F-u-T]

*PSA & Update*

The trial is specifically looking for people who can pinpoint the event in which their hearing loss occurred (and I suppose it is thus heavily implied only people with NIHL are eligible for this phase).

You will only be eligible for this trial if you can say something like, "That gunshot two years ago is the event in which I experienced hearing loss" or "After I went to that really loud concert is when it became apparent I had hearing loss."

If you cannot pinpoint an event responsible for your hearing loss, you will not be eligible for the trial.

They've actually been having difficulty finding eligible candidates under these trial parameters.

I know exactly when my tinnitus started from NIHL. One really loud music event was all it took. I only have a minor dip in higher frequency range but still within normal for my age group. I had an audiogram prior to acoustic trauma to compare to which showed the slight dip. Probably not enough for the trial requirements though.

 

[Jurger]

I see a lot of people still thinking that they, figuratively speaking, will find this drug under their Christmas tree next year. People, this is not going to happen. They have to go through Phase 2a, then Phase 2b, then Phase 3. If we're unlucky they might even have to do a Phase 3b. Each of those phases takes about a year, and usually there are about 4-6 months between each phase. Do the math.

Now, if we had a situation on our hands where the Phase 1/2 results were stellar, this positive thinking might have had some merit. But they weren't.

This "maybe it's out in 18 months" is really just a - completely understandable - coping mechanism.

 

[JohnAdams]

I see a lot of people still thinking that they, figuratively speaking, will find this drug under their Christmas tree next year. People, this is not going to happen. They have to go through Phase 2a, then Phase 2b, then Phase 3. If we're unlucky they might even have to do a Phase 3b. Each of those phases takes about a year, and usually there are about 4-6 months between each phase. Do the math.

Now, if we had a situation on our hands where the Phase 1/2 results were stellar, this positive thinking might have had some merit. But they weren't.

This "maybe it's out in 18 months" is really just a - completely understandable - coping mechanism.

What are you babbling about? No one is saying 18 months.

 

[tarmaced]

I see a lot of people still thinking that they, figuratively speaking, will find this drug under their Christmas tree next year. People, this is not going to happen. They have to go through Phase 2a, then Phase 2b, then Phase 3. If we're unlucky they might even have to do a Phase 3b. Each of those phases takes about a year, and usually there are about 4-6 months between each phase. Do the math.

Now, if we had a situation on our hands where the Phase 1/2 results were stellar, this positive thinking might have had some merit. But they weren't.

This "maybe it's out in 18 months" is really just a - completely understandable - coping mechanism.

Phase 3 might not be required however.

 

[Jurger]

Phase 3 might not be required however.

It might not, but there's an equal possibility it has to go through a Phase 3b. We just don't know. It all depends on how well the drug performs in this phase 2a trial. We should have a lot more information when top-line results are released this time next year. And even then, it's possible drug performance fluctuates in future trials.

 

[JohnAdams]

The drug probably did reach the apex in trace amounts but since this stuff is dose dependent it didn't trigger proliferation.

 

[Lucifer]

The drug probably did reach the apex in trace amounts but since this stuff is dose dependent it didn't trigger proliferation.

Would each person have a different size Apex as well. So some people might need more than others?

 

[Rb86]

*PSA & Update*

The trial is specifically looking for people who can pinpoint the event in which their hearing loss occurred (and I suppose it is thus heavily implied only people with NIHL are eligible for this phase).

You will only be eligible for this trial if you can say something like, "That gunshot two years ago is the event in which I experienced hearing loss" or "After I went to that really loud concert is when it became apparent I had hearing loss."

If you cannot pinpoint an event responsible for your hearing loss, you will not be eligible for the trial.

They've actually been having difficulty finding eligible candidates under these trial parameters.

Well you'd be wrong because I am exactly that case. I can pinpoint it to the day and I was still turned down.

 

[Deathtotinni]

I think they are still looking for volunteers?

Go to the website and ring the number. They will tell you to send an audiogram through and will let you know if you qualify or not.

At this stage if you don't have much hearing loss you won't qualify.

I have enough hearing loss I think. I had enough hearing loss for the last trial.

 

[tarmaced]

The drug probably did reach the apex in trace amounts but since this stuff is dose dependent it didn't trigger proliferation.

Hope so! Trouble is I can't help but feel that the exposure decay will be exponential within the cochlea - a bit like dropping a blob of paint and examining the volume that remains inside a given radius of the impact. Given such a decay it could need a LOT of drug to have any impact.

 

[mrbrightside614]

Just read something that really scared me about the efficacy of stem cells, even when administered IT.

Even if FX-322 bypasses the need to infuse stem cells with growth factors for appropriate cell differentiation... "in past experiments, transplantation of stem cells into the damaged areas has produced only varying results, and a challenging problem that prevents successful stem cell transplantation is to avoid stem cell deaths. Stem cells often die due to failure to bypass the glial scar, a hallmark of neural damage that is thought to act as a barrier for cell transplantation."

This has been addressed by a research team in Kyoto, who "discovered that applying new stem cells to the surface of the glial scar rather than underneath it helps their survival. They reported that the survived stem cells were able to grow from the damaged segment of the auditory nerve, which then travel from the cochlea to the brainstem, the part of the brain which controls flow of messages between the brain and the rest of the body – in this case, the ear - and eventually restored remarkable auditory function."

Is the idea that the slow release gel will somehow "soak" into all of the damaged areas in question, including the glial scar? Any way we could get Frequency Therapeutics on the Tinnitus Talk Podcast? Do we have any contact information besides their LinkedIn?

 

[JohnAdams]

Would each person have a different size Apex as well. So some people might need more than others?

It's probably close.

 

[FGG]

Just read something that really scared me about the efficacy of stem cells, even when administered IT.

Even if FX-322 bypasses the need to infuse stem cells with growth factors for appropriate cell differentiation... "in past experiments, transplantation of stem cells into the damaged areas has produced only varying results, and a challenging problem that prevents successful stem cell transplantation is to avoid stem cell deaths. Stem cells often die due to failure to bypass the glial scar, a hallmark of neural damage that is thought to act as a barrier for cell transplantation."

This has been addressed by a research team in Kyoto, who "discovered that applying new stem cells to the surface of the glial scar rather than underneath it helps their survival. They reported that the survived stem cells were able to grow from the damaged segment of the auditory nerve, which then travel from the cochlea to the brainstem, the part of the brain which controls flow of messages between the brain and the rest of the body – in this case, the ear - and eventually restored remarkable auditory function."

Is the idea that the slow release gel will somehow "soak" into all of the damaged areas in question, including the glial scar? Any way we could get Frequency Therapeutics on the Tinnitus Talk Podcast? Do we have any contact information besides their LinkedIn?

I don't think the glial scar is an issue because the drug causes supporting cells to divide where they are.

 

[mrbrightside614]

I don't think the glial scar is an issue because the drug causes supporting cells to divide where they are.

I guess I'm unclear as to the mechanisms here. I saw the visual model prior, but wouldn't lack of support cells post-differentiation also be cause for concern?

 

[FGG]

I guess I'm unclear as to the mechanisms here. I saw the visual model prior, but wouldn't lack of support cells post-differentiation also be cause for concern?

Not sure what you mean.

 

[mrbrightside614]

Not sure what you mean.

Does the division of the support cell into the hair cell deplete the original cell or does it simply divide and remain intact?

 

[FGG]

Does the division of the support cell into the hair cell deplete the original cell or does it simply divide and remain intact?

The division happens first. There is no depletion of supporting cells with FX-322. This seems to differ from REGAIN.

 

[JohnAdams]

Does the division of the support cell into the hair cell deplete the original cell or does it simply divide and remain intact?

With FX-322 it is supposed to divide the supporting cells and then make a hair cell so it maintains supporting cell numbers.

 

[mrbrightside614]

Lovely news. We're looking at 18 months minimum? I can stick it out til then. Swear if they don't end up serving tinnitus patients I'm blowing this ear out.

 

[ChrisBoyMonkey]

Lovely news. We're looking at 18 months minimum? I can stick it out til then.

Keep in mind we don't actually know if it helps with tinnitus yet.

Best bets are probably on neuromodulation devices and maybe the pills so far.

 

[mrbrightside614]

Keep in mind we don't actually know if it helps with tinnitus yet.

Best bets are probably on neuromodulation devices and maybe the pills so far.

What makes you partial to the pill over FX-322? Systemic circulation seems like a reach to me. Would imagine there would be significantly greater potential for side effects and bioavailability issues.

 

[FGG]

Keep in mind we don't actually know if it helps with tinnitus yet.

Best bets are probably on neuromodulation devices and maybe the pills so far.

I think it's impossible to say what the "best bet" is at this stage. The pills are as much of an unknown as the injections and neuromodulation seems to be very patient dependent. Unless Dr. Shore's device can help a greater percentage of people.

 

[vttbx]

No one can truly say. It all depends on how well it goes in next the trial. This time they will also be checking how it works for tinnitus. If the results are mind bending and very successful i am positive that we will be seeing something in less than 3 years with fast tracking. If the results are not conclusive or only yields slight improvement, it will be a long road or not be made available at all. That's just an estimated guess.

Do you know if the fast track approval applies to only this current phase? Or does it carry over to the future phases as well?

 

[ChrisBoyMonkey]

What makes you partial to the pill over FX-322? Systemic circulation seems like a reach to me. Would imagine there would be significantly greater potential for side effects and bioavailability issues.

It's just based on what we have been hearing from HEI. They said they have seen some amazing results. We should be having a podcast with them very soon.