Frequency Therapeutics — Hearing Loss Regeneration

[Artemis2K]

I wonder what would happen if some trial subjects call back to report improvements in their hearing at 12+ months. Would they consider restarting the project or is it just dead forever?

If the FX-345 subjects reported good results and Frequency Therapeutics was able to authenticate it, then they might be able to start back... assuming that they get the capital to continue.

That would be quite a miracle. I could see the good results happening being plausible, but so much would have to happen for them to continue on again.

 

[Lucifer]

I wonder what would happen if some trial subjects call back to report improvements in their hearing at 12+ months. Would they consider restarting the project or is it just dead forever?

I would love to see some of the FX-322 patients try out a version of OTO-413 that may be going to clinical trial in 2024 by Spiral Therapeutics.

Maybe the missing puzzle is OTO-413.

 

[RingingBrother]

If the FX-345 subjects reported good results and Frequency Therapeutics was able to authenticate it, then they might be able to start back... assuming that they get the capital to continue.

That would be quite a miracle. I could see the good results happening being plausible, but so much would have to happen for them to continue on again.

To me it just felt too soon to cancel the drug at 90 days after correcting the trial design. They should have compared day 1 of injection to at least a year later. It would be a shame if people are improving later on but it's too late to continue the trials.

I would love to see some of the FX-322 patients try out a version of OTO-413 that may be going to clinical trial in 2024 by Spiral Therapeutics.

Maybe the missing puzzle is OTO-413.

Spiral Therapeutics should try to get their own version of FX-322/FX-345 and try them all out in a trial.

 

[patorjk]

To me it just felt too soon to cancel the drug at 90 days after correcting the trial design. They should have compared day 1 of injection to at least a year later. It would be a shame if people are improving later on but it's too late to continue the trials.

Spiral Therapeutics should try to get their own version of FX-322/FX-345 and try them all out in a trial.

He was asked about this on Twitter and replied "No plan to do that. Not convinced that drug delivery was FX-322's only challenge". I found this kind of interesting since his thread on FX-322 failing focused mostly on drug delivery, and didn't mention anything else. Also of note is that his company didn't acquire Otonomy's OTO-6XX program (no one did). I wonder if he believes there are other hurdles for hair cell regeneration?

 

[Pharz]

Where are those two company advocates who said that the fall in share prices are just people taking profits now? People are miserable, do you have any response to getting their hopes so high?

Luckily Frequency Therapeutics' first failure taught some of us lessons in not getting your hopes high and to remain realistic about the situation.

 

[chinup]

Frequency Therapeutics Announces Topline Results for its Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss

"FX-322-208 Study Fails to Meet Primary Endpoint, Showing No Significant Separation in Speech Perception Between FX-322 and Placebo

Company Will Now Focus on Advancing its Program in Remyelination for Multiple Sclerosis (MS)"​

FX-345 is also discontinued.

Anyone else here also have MS along with tinnitus or hyperacusis? Is Frequency Therapeutics' remyelination treatment supposed to be a big deal?

 

[rei]

Anyone else here also have MS along with tinnitus or hyperacusis? Is Frequency Therapeutics' remyelination treatment supposed to be a big deal?

I don't have MS but I know people who do. Apparently, they have more faith in it than they have in FX-345. Makes sense from a drug delivery and testing standpoint. A single oral dose and some imaging compared to drugs that may not even be hitting the target. As much as it pains me, I understand their thinking. Hopefully they'll be successful, only time will tell.

 

[Tau]

compared to drugs that may not even be hitting the target. As much as it pains me, I understand their thinking.

To be honest, FX-322 did reach 10 kHz at required concentrations of CHIR99021 and sodium valproate to work. Now testing speech was an interesting choice, but it makes sense because understanding speech is one the main goals of hearing restoration.

Getting deeper required *some* changes to the formulation, and it was very easily doable, even without changing the active compounds in FX-322, with the downside that the tonicity would increase (see my post in the FX-345 thread).

 

[Artemis2K]

Anyone else here also have MS along with tinnitus or hyperacusis? Is Frequency Therapeutics' remyelination treatment supposed to be a big deal?

The regeneration of myelin is supposed to be a natural process for most people, although that ability naturally declines starting later in adulthood (I think 30s.)

Supplements like Vitamin D and Magnesium are supposed to be really good for myelination, so the science of an oral drug does actually make sense.

If they manage to produce myelin for those that have MS, as well as make an impact for older adults, that would be a tremendous deal.

 

[d'Wooluf]

@Tau, didn't they do a trial (in Germany?) that determined that the drug did reach the site of action? It was a weird way of putting it. It was like the drug got where it was supposed to, because that is where it got. Speech-in-noise scores only became the main endpoint when it was obvious nothing was happening on the audiograms. It was a 'choice' dictated by their need to stay publicly positive at all times.

 

[Nick47]

They used cochlear implant patients to determine that the drug reached the cochlea and got where it needed. The delivery was not the issue. The drug doesn't work.

 

[Kleiner]

They used cochlear implant patients to determine that the drug reached the cochlea and got where it needed. The delivery was not the issue. The drug doesn't work.

For a so-called scientist, I noticed that you are very approximate in your interventions. Like when you claimed FX-345 was the same formulation as FX-322, which is wrong, and easily verifiable.

Thank you for using the conditional, you don't know more than another (although I share the skepticism about FX-322).

 

[Nick47]

For a so-called scientist, I noticed that you are very approximate in your interventions. Like when you claimed FX-345 was the same formulation as FX-322, which is wrong, and easily verifiable.

Thank you for using the conditional, you don't know more than another (although I share the skepticism about FX-322).

@Kleiner, I have to admit I did think it was the same. I sometimes get things wrong and make mistakes.

Frequency Therapeutics did use the cochlear implant technology to check on permeability though, which would suggest it's not the delivery system.

 

[rei]

To be honest, FX-322 did reach 10 kHz at required concentrations of CHIR99021 and sodium valproate to work. Now testing speech was an interesting choice, but it makes sense because understanding speech is one the main goals of hearing restoration.

Getting deeper required *some* changes to the formulation, and it was very easily doable, even without changing the active compounds in FX-322, with the downside that the tonicity would increase (see my post in the FX-345 thread).

If Hugo Peris is right, then the injection itself doesn't hit the mark much of the time.

 

[Tau]

@Kleiner, I have to admit I did think it was the same. I sometimes get things wrong and make mistakes.

Frequency Therapeutics did use the cochlear implant technology to check on permeability though, which would suggest it's not the delivery system.

Yes, and from this and their modelling they 100% knew that it would not really be effective below 9-10 kHz.

 

[Pero1234]

Now to find a Frequency Therapeutics thread on an MS community, where FREQ stock owners can keep discussing and following the progress of their MS treatment (and the evolution of their stock prices the coming years). Another 660+ pages in a few years' time, before they file for bankruptcy in the end...

 

[scotty03874]

Where are those two company advocates who said that the fall in share prices are just people taking profits now? People are miserable, do you have any response to getting their hopes so high?

Luckily Frequency Therapeutics' first failure taught some of us lessons in not getting your hopes high and to remain realistic about the situation.

One was me, @Pharz. I had hoped they would successfully achieve their intended trial result goals, but they didn't and it's over for Frequency Therapeutics' hearing program pipeline. Oh well, we all hoped, but they failed. Life goes on...

 

[Artemis2K]

If Hugo Peris is right, then the injection itself doesn't hit the mark much of the time.

Makes me wonder of the feasibility of using nano cameras on the syringe. Maybe with a low level laser as a pointer if necessary and if such a thing can be small enough and farthest away so that there are no complications.

Then the only thing left would be stability and physics making sure it goes where it needs to go.

Wonder how much that would cost lol.

 

[RingingBrother]

One was me, @Pharz. I had hoped they would successfully achieve their intended trial result goals, but they didn't and it's over for Frequency Therapeutics' hearing program pipeline. Oh well, we all hoped, but they failed. Life goes on...

I think a more established company with already approved drugs and lots of money should keep testing these drugs indefinitely due to the fact they can restore hair cells in mice. That alone is huge progress that shouldn't be abandoned.

 

[chinup]

The regeneration of myelin is supposed to be a natural process for most people, although that ability naturally declines starting later in adulthood (I think 30s.)

Supplements like Vitamin D and Magnesium are supposed to be really good for myelination, so the science of an oral drug does actually make sense.

If they manage to produce myelin for those that have MS, as well as make an impact for older adults, that would be a tremendous deal.

Yeah I'm just getting to the age and progression of the disease where stuff is going numb on me and not coming back. Lots of other symptoms too, the cognitive issues are the most worrisome imo.

It's funny how there's this huge community around MS and doctors working nonstop with tons of funding and lots of progress being made. When I tell people I have MS, they take it so much more seriously than they do when I say I have severe hyperacusis. No one cares about that at all.

Truth is unless you are very late stage or have a rapidly progressing version, MS is a cakewalk compared to what we go thru with severe tinnitus and hyperacusis.

 

[Nick47]

I think a more established company with already approved drugs and lots of money should keep testing these drugs indefinitely due to the fact they can restore hair cells in mice. That alone is huge progress that shouldn't be abandoned.

@RingingBrother, the problem is a high proportion of animal studies do not translate to humans.

 

[Chad Lawton]

One was me, @Pharz. I had hoped they would successfully achieve their intended trial result goals, but they didn't and it's over for Frequency Therapeutics' hearing program pipeline. Oh well, we all hoped, but they failed. Life goes on...

And the other one was me. I didn't predict the company would commit fraud in my opinion.

On April 8th, 2022, the company filed an 8-K with the SEC stating that they laid of 30% of their workforce. In the filing they state:

"These changes will preserve capital, ensuring that the Company is appropriately resourced to advance its pipeline of potential first-in-class treatments through key development milestones. These milestones are the completion of the Phase 2b study of FX-322, a Phase 1b study of FX-345, and a Phase 1 study in the Multiple Sclerosis program."​

They said it would ENSURE a Phase 1b study of FX-345, yet here we sit with the FX-345 trial abandoned halfway through and no data to go along with it. As recently as December on their investor presentation, Lucchino stated "and we will have data from that program in the 2nd half of 2023" when speaking about FX-345. If that isn't fraud, I don't know what is.

What's even funnier is the company saying the same bull@#$^ again in their most recent filing. It states that with the most recent round of job cuts that "These changes will preserve capital, ensuring that the Company is appropriately resourced to complete a first clinical trial of its MS Program." Management seems more interested in extending their cash pile in order to keep collecting their half million dollar salaries for a couple more years rather than do what is best for patients and investors.

I was extremely bullish on the company before but after this stunt they pulled, they seem like fraudsters to me now.

 

[Jonno02]

And the other one was me. I didn't predict the company would commit fraud in my opinion.

On April 8th, 2022, the company filed an 8-K with the SEC stating that they laid of 30% of their workforce. In the filing they state:

"These changes will preserve capital, ensuring that the Company is appropriately resourced to advance its pipeline of potential first-in-class treatments through key development milestones. These milestones are the completion of the Phase 2b study of FX-322, a Phase 1b study of FX-345, and a Phase 1 study in the Multiple Sclerosis program."​

They said it would ENSURE a Phase 1b study of FX-345, yet here we sit with the FX-345 trial abandoned halfway through and no data to go along with it. As recently as December on their investor presentation, Lucchino stated "and we will have data from that program in the 2nd half of 2023" when speaking about FX-345. If that isn't fraud, I don't know what is.

What's even funnier is the company saying the same bull@#$^ again in their most recent filing. It states that with the most recent round of job cuts that "These changes will preserve capital, ensuring that the Company is appropriately resourced to complete a first clinical trial of its MS Program." Management seems more interested in extending their cash pile in order to keep collecting their half million dollar salaries for a couple more years rather than do what is best for patients and investors.

I was extremely bullish on the company before but after this stunt they pulled, they seem like fraudsters to me now.

In my own experience with start-ups (biotechs), the senior management that bring nothing to the company all earn £500,000+, the project managers that know nothing about science at all earn £100,000+ and the extremely intelligent scientists that design the products earn £40,000 at a push.

So you're probably right.

 

[Nick47]

Well, unless you're in it to make money, the best place for donations and funding seem to be the universities and non-profit organisations (Hough Ear Institute excluded) as they stick around. Added to that, it's where the best treatments for inner ear disorders seem to have come from (cochlear implants and Auricle to name two), although progress may be slower and less aggressive. The Bionics Institute may also return an objective test to the clinics.

It's not just Frequency Therapeutics, but also Otonomy that have fallen in spectacular fashion, with 4 treatments not meeting any endpoints in 6 months. Cue mass scientific culling/liquidation and the owners running off not out of pocket.

 

[scotty03874]

If there were a new class action filed for fraud like with their CBS News BS, I would gladly join it or be a class representative.

 

[Lucifer]

And the other one was me. I didn't predict the company would commit fraud in my opinion.

On April 8th, 2022, the company filed an 8-K with the SEC stating that they laid of 30% of their workforce. In the filing they state:

"These changes will preserve capital, ensuring that the Company is appropriately resourced to advance its pipeline of potential first-in-class treatments through key development milestones. These milestones are the completion of the Phase 2b study of FX-322, a Phase 1b study of FX-345, and a Phase 1 study in the Multiple Sclerosis program."​

They said it would ENSURE a Phase 1b study of FX-345, yet here we sit with the FX-345 trial abandoned halfway through and no data to go along with it. As recently as December on their investor presentation, Lucchino stated "and we will have data from that program in the 2nd half of 2023" when speaking about FX-345. If that isn't fraud, I don't know what is.

What's even funnier is the company saying the same bull@#$^ again in their most recent filing. It states that with the most recent round of job cuts that "These changes will preserve capital, ensuring that the Company is appropriately resourced to complete a first clinical trial of its MS Program." Management seems more interested in extending their cash pile in order to keep collecting their half million dollar salaries for a couple more years rather than do what is best for patients and investors.

I was extremely bullish on the company before but after this stunt they pulled, they seem like fraudsters to me now.

I hope this doesn't happen with Spiral Therapeutics. They bought the rights of OTO-413 as they believe it could work better with their delivery method. OTO-413 also had better efficacy results in their successful Phase 1 & 2a trials at the 0.3 mg dose compared to FX-322.

I really do hope the results in the previous OTO-413 trials weren't a fluke like Frequency Therapeutics'. It goes to show that even with successful results in previous FX-322 trials, it could basically fail in the later trials.

 

[Artemis2K]

And the other one was me. I didn't predict the company would commit fraud in my opinion.

On April 8th, 2022, the company filed an 8-K with the SEC stating that they laid of 30% of their workforce. In the filing they state:

"These changes will preserve capital, ensuring that the Company is appropriately resourced to advance its pipeline of potential first-in-class treatments through key development milestones. These milestones are the completion of the Phase 2b study of FX-322, a Phase 1b study of FX-345, and a Phase 1 study in the Multiple Sclerosis program."​

They said it would ENSURE a Phase 1b study of FX-345, yet here we sit with the FX-345 trial abandoned halfway through and no data to go along with it. As recently as December on their investor presentation, Lucchino stated "and we will have data from that program in the 2nd half of 2023" when speaking about FX-345. If that isn't fraud, I don't know what is.

What's even funnier is the company saying the same bull@#$^ again in their most recent filing. It states that with the most recent round of job cuts that "These changes will preserve capital, ensuring that the Company is appropriately resourced to complete a first clinical trial of its MS Program." Management seems more interested in extending their cash pile in order to keep collecting their half million dollar salaries for a couple more years rather than do what is best for patients and investors.

I was extremely bullish on the company before but after this stunt they pulled, they seem like fraudsters to me now.

Yikes. I can see why you'd think that. That certainly is very suspicious. They ought to explain this.

I hope this doesn't happen with Spiral Therapeutics. They bought the rights of OTO-413 as they believe it could work better with their delivery method. OTO-413 also had better efficacy results in their successful Phase 1 & 2a trials at the 0.3 mg dose compared to FX-322.

I really do hope the results in the previous OTO-413 trials weren't a fluke like Frequency Therapeutics'. It goes to show that even with successful results in previous FX-322 trials, it could basically fail in the later trials.

I'm optimistic that Spiral Therapeutics is competent. They've been watching the results and practices of those two companies. I would hope they would want to avoid the same mistakes.

 

[Lucifer]

I'm optimistic that Spiral Therapeutics is competent. They've been watching the results and practices of those two companies. I would hope they would want to avoid the same mistakes.

Same, I'm optimistic about Spiral Therapeutics as well. They wouldn't have bought OTO-413 if they didn't believe the drug works but Astellas Pharma did the same with FX-322 and look how that turned out. The only difference is efficacy in OTO-413 was much better compared to FX-322.

All that is left for Spiral Therapeutics to do is to see if OTO-413 shows the same efficacy in the previous trials with at least 100 participants or more at the 0.3 mg dose.

 

[GlennS]

And the other one was me. I didn't predict the company would commit fraud in my opinion.

On April 8th, 2022, the company filed an 8-K with the SEC stating that they laid of 30% of their workforce. In the filing they state:

"These changes will preserve capital, ensuring that the Company is appropriately resourced to advance its pipeline of potential first-in-class treatments through key development milestones. These milestones are the completion of the Phase 2b study of FX-322, a Phase 1b study of FX-345, and a Phase 1 study in the Multiple Sclerosis program."​

They said it would ENSURE a Phase 1b study of FX-345, yet here we sit with the FX-345 trial abandoned halfway through and no data to go along with it. As recently as December on their investor presentation, Lucchino stated "and we will have data from that program in the 2nd half of 2023" when speaking about FX-345. If that isn't fraud, I don't know what is.

What's even funnier is the company saying the same bull@#$^ again in their most recent filing. It states that with the most recent round of job cuts that "These changes will preserve capital, ensuring that the Company is appropriately resourced to complete a first clinical trial of its MS Program." Management seems more interested in extending their cash pile in order to keep collecting their half million dollar salaries for a couple more years rather than do what is best for patients and investors.

I was extremely bullish on the company before but after this stunt they pulled, they seem like fraudsters to me now.

 

[Nick47]

I was going to consider a cochlear implant in my late 30s or early 40s if nothing develops. I am 31 currently.

@Koz, were you born with hearing loss, or gradually/suddenly acquired it? If you are/were holding off on a cochlear implant for regeneration of chronic hearing loss, then don't. There is nothing even in a Phase 1 trial. Get it done and live your life.