Frequency Therapeutics — Hearing Loss Regeneration

[JohnAdams]

Flamingo1, no dude.

I think you're confounding the guy with a brain tumor that donated his cochlea for the first ex-vivo experiment to see if this worked in humans with the last trial where it was being tested for safety in people that were getting cochlear implants.

 

[FGG]

No, they are giving some speech on the 10th at a symposium or something. I was totally blindsided by this announcement.

I think the presentation is on the 17th. Curious what they will say.

 

[ajc]

Guys,

the presentation will be a whopping 5 minutes. FIVE MINUTES.

Don't expect too much...

https://plan.core-apps.com/aao2019/event/d29afee0ef623a96e8827526a952c271

 

[Enclave]

I think there's room to be optimistic here. Frequency's largest administered dose in this study was 0.2 milliliters of FX-322. Audion stated in their GSI study that the maximum volume of solution allowed in the cochlea was 500 micro-liters. If you convert 500 micro-liters to milliliters, you arrive at 0.5 milliliters of maximum allowable solution. Frequency only utilized 0.2 milliliters for their max dose in the 1b trial. So if you think about it, with 0.2 milliliters they were able to show a 10 dB increase at 8000 Hz. Now if we increase the volume to let's say 0.4mL of FX-322 then maybe that's enough to reach the 6000 Hz or 4000 Hz area of the cochlea.

 

[Flamingo1]

I think you're confounding the guy with a brain tumor that donated his cochlea for the first ex-vivo experiment to see if this worked in humans with the last trial where it was being tested for safety in people that were getting cochlear implants.

So this trial done on people getting cochlear implants (which is what I meant in my last post.) If true, I stand by my point that the patients in this study had extremely compromised hearing to start with. Perhaps audiogram improvements are more likely in patients with healthier cochlea.

 

[FGG]

So this trial done on people getting cochlear implants (which is what I meant in my last post.) If true, I stand by my point that the patients in this study had extremely compromised hearing to start with. Perhaps audiogram improvements are more likely in patients with healthier cochlea.

Where did you hear it was for cochlear implant patients? They said the improvement was in those with moderate to moderately severe loss. This is not a cochlear implant population, which would be severe to profound loss.

Are you thinking of a regeneration study by a different company?

 

[JohnAdams]

Where did you hear it was for cochlear implant patients? They said the improvement was in those with moderate to moderately severe loss. This is not a cochlear implant population, which would be severe to profound loss.

Are you thinking of a regeneration study by a different company?

The first trial with FX-322 last year was in cochlear implant patients.

 

[FGG]

The first trial with FX-322 last year was in cochlear implant patients.

The results from phase 1 were from cochlear implant patients? How did I miss that?

 

[JohnAdams]

The results from phase 1 were from cochlear implant patients? How did I miss that?

We are only human, prone to mistakes, that is why we all need each other in an honest and humble manner, forgiving, and able to accept our own missteps and ignorance. I am of a firm belief that if we would honestly come together in confidence and due diligence that this community could be a strong area of research. What we need to accept is that we have an ability to research despite a lack of degree or pedigree whatever. You guys already know I put much energy into this regardless of a clear-cut path to success.

TRY TRY TRY

https://clinicaltrials.gov/ct2/show/NCT03300687

 

[FGG]

We are only human, prone to mistakes, that is why we all need each other in an honest and humble manner, forgiving, and able to accept our own missteps and ignorance. I am of a firm belief that if we would honestly come together in confidence and due diligence that this community could be a strong area of research. What we need to accept is that we have an ability to research despite a lack of degree or pedigree whatever. You guys already know I put much energy into this regardless of a clear-cut path to success.

TRY TRY TRY

https://clinicaltrials.gov/ct2/show/NCT03300687
View attachment 31804

Oh wow, totally missed this.

Did they publish any audiological results from the cochlear implant study?

 

[JohnAdams]

Oh wow, totally missed this.

Did they publish any audiological results from the cochlear implant study?

Don't think so. I don't think it would have mattered after cochlear implants anyway.

 

[d'Wooluf]

The results from phase 1 were from cochlear implant patients? How did I miss that?

He got it confused with the phase 1a study that was done in Melbourne. That was only about tolerability.

 

[FGG]

Found a tweet with the names of some of Frequency's investors. Seems like a list of extremely savvy and well know biotech venture capitalists. I highly doubt they (along with Astrellas) don't view Frequency's phase 1 results as promising.

https://endpts.com/the-top-100-biotech-vc-firms/

 

[vttbx]

No they are starting Phase 2a by end of this year. And Phase 2b next year.

So basically we are in the 5-10 year range for completion?

 

[Coleoptere]

I think there's room to be optimistic here. Frequency's largest administered dose in this study was 0.2 milliliters of FX-322. Audion stated in their GSI study that the maximum volume of solution allowed in the cochlea was 500 micro-liters. If you convert 500 micro-liters to milliliters, you arrive at 0.5 milliliters of maximum allowable solution. Frequency only utilized 0.2 milliliters for their max dose in the 1b trial. So if you think about it, with 0.2 milliliters they were able to show a 10 dB increase at 8000 Hz. Now if we increase the volume to let's say 0.4mL of FX-322 then maybe that's enough to reach the 6000 Hz or 4000 Hz area of the cochlea.

Maybe they can already do audiograms on the Phase 1b patients to prove changes in 8-16 kHz.

Or do they need a 100.000 pages report for the FDA impediment to allow for that?

 

[mxmpc]

Things are heading in a bad direction. Just like what I said before, another AM-101...

 

[Flamingo1]

https://clinicaltrials.gov/ct2/show/NCT03300687
View attachment 31804

I'm confused. Are the results being discussed now not from the cochlear implant study?

 

[Flamingo1]

So basically we are in the 5-10 year range for completion?

Let's hope they improve results within that time span. With the disappointing results announced so far, I won't be standing in line for it now. Considering they are just now starting to test this in humans, there is plenty of room for improvement.

 

[Daniel Lion]

I'm confused. Are the results being discussed now from this study?

No, they are not. Go back a page and @ajc has a link to a huge 120 paper, pertaining to the 1b trial, not the 1a in Australia.

FGG, thanks for weighing in, I agree with your conclusions and they are a welcome counter to what I find to be non-objective knee jerk cynicism. My faith in this company has not wavered, not yet at least.

 

[Rubenslash]

I'm confused. Are the results being discussed now not from the cochlear implant study?

They are not from that study. The CI study was in Australia, the ones discussed here is phase 1 conducted in the US.

I hate the negativity here, let's see what phase 2 brings where they will actually use multiple and higher doses aimed to measure efficacy, which was not at all the purpose of phase 1.

IPO is a good thing, increases transparency. Nothing to do with cashing out as some argue here (not even sure that existing shareholders will actually sell any of their stake). Pretty much all of the successful biotechs are listed on the stock market. Due to the nature of the business (years of expenses and investments without revenue), it makes perfect sense.

 

[Mr Mister]

I think there's room to be optimistic here. Frequency's largest administered dose in this study was 0.2 milliliters of FX-322. Audion stated in their GSI study that the maximum volume of solution allowed in the cochlea was 500 micro-liters. If you convert 500 micro-liters to milliliters, you arrive at 0.5 milliliters of maximum allowable solution. Frequency only utilized 0.2 milliliters for their max dose in the 1b trial. So if you think about it, with 0.2 milliliters they were able to show a 10 dB increase at 8000 Hz. Now if we increase the volume to let's say 0.4mL of FX-322 then maybe that's enough to reach the 6000 Hz or 4000 Hz area of the cochlea.

Drug safety is dose-dependent. Think about for example paracetamol which is a safe pain killer with recommended doses but higher doses can cause fatal liver damage. It is kind of hard to see what is the point of safety trials if in the following trials they immediately increase the doses several times higher.

 

[d'Wooluf]

I'm confused. Are the results being discussed now not from the cochlear implant study?

No, they're not. The "cochlear implant" study involved injecting the drug just hours before the implant. There were no audiograms or any other test to do with hearing. Just testing for general ill-effects and physical examination to test for the presence of the drug in the cochlea (good) or presence of the drug in the rest of the body (bad).

 

[Daniel Lion]

Let's hope they improve results within that time span. With the disappointing results announced so far, I won't be standing in line for it now. Considering they are just now starting to test this in humans, there is plenty of room for improvement.

Why disappointing? And what line do we stand in when we have severe hearing loss and problems because of this? There is no line my beautiful bird friend. We're basically f-cked. Big bird was an optimist, though a fairly neurotic one.

This was a safety trial that showed improvements. In the next trial different groups will receive 2 injections, 3 injections, 4 injections, and full on placebo as I recall. I am optimistic still especially with all the money being invested and that MIT is involved as well as Mass Eye and Ear, and the heavy weight biochemists they have working for them. I feel pretty good thus far as an arm chair tinnitus forum observer with NIHL. This has never been done before, never. Surely the hundreds of millions of dollars being projected and invested should be comforting. I would like it tomorrow, I would also like world peace, and a cleaner earth. Can we cut these folks a little slack for stepping up to the plate and taking on hearing regeneration in the inner ear. So far so good...

Go team FX-322... you rock, hope you kick ass and pass the next two trials, with great results...

 

[FGG]

Maybe they can already do audiograms on the Phase 1b patients to prove changes in 8-16 kHz.

Or do they need a 100.000 pages report for the FDA impediment to allow for that?

They may have for their own internal information but if it wasn't part of their original design, I don't think they can report that (not 100% sure though). It may be in information they disclosed to private investors though.

The FDA has guidelines that have to be followed to the letter for approval and phase 1 was a safety not efficacy study.

 

[JohnAdams]

Are you guys ready to organize and try and start a lobby to specifically speed up access to this like all the AIDS people did in the early 90s?

 

[Daniel Lion]

Are you guys ready to organize and try and start a lobby to specifically speed up access to this like all the AIDS people did in the early 90s?

Yes.

Tell me what to do and I will do it.

 

[JohnAdams]

@kilokalori

So glad that's funny to you. Many of us here are on the verge of suicide. Other disease communities have successfully done exactly what I am proposing.

 

[StephanieLC]

@kilokalori

So glad that's funny to you. Many of us here are on the verge of suicide. Other disease communities have successfully done exactly what I am proposing.

I don't completely agree with that funny review but I don't think efforts to try to lobby anything would bear fruit.

Frequency's next step is the IPO, and that is serious business. They won't be giving the drug away to desperate AIDS tinnitus patients in the next 10 years before the clinical trials are formally done with and efficacy proven.

They are money and investor driven, they are not going to risk any legal trouble.

 

[JohnAdams]

I don't completely agree with that funny review but I don't think efforts to try to lobby anything would bear fruit.

Oh well then I guess we shouldn't even try then huh? If you don't want to participate then don't. Just don't fight against those of us that would want to.

 

[JohnAdams]

Yes.

Tell me what to do and I will do it.

For now, just do what I'm doing and spam this idea on this thread periodically, the inner hair cell regeneration thread, and other threads where it won't be considered off topic. There are many lurkers on this site and we just have to plant the seed.

Get on Twitter and spam this idea on all kinds of random threads.