Frequency Therapeutics — Hearing Loss Regeneration

The only thing about that is that the drugs being delivered would have to be mixed with a ferrous nanoparticle substance, which may or not be ototoxic, it will also dilute the medicine.

Just FYI, ferrous means a metal that will interact with a magnetic field.

But yeah, if this can avoid the need for an injection, then, awesome. After 72 of them, I can conclusively say that it is NOT fun.

 

http://otomagnetics.net/The-Importance-of-Finding-an-Answer-to-Tinnitus

It's almost like they are hinting at Frequency Therapeutics to collaborate with them

 

Anyone got a link? Or a recording of the session?

 

Local company working on treatment to reverse...

Phase one of the FDA process included injecting 24 patients with a gel during a five minute outpatient procedure last year.

"Phase 1 proved no safety issues and that's all that study was designed to do," Lucchino said.

Phase 2 will explore if the drug can be used in multiple doses.

If all goes well, Frequency Therapeutics plans on asking the FDA to fast track the drug, citing recent studies that link hearing loss to other diseases like depression and dementia.

 

Here you go:

https://www.wcvb.com/article/local-company-working-on-treatment-to-reverse-hearing-loss/26596728

Written article as well as video.

 

I could watch it with a VPN. It was a shit segment to be honest. Local news click-bait pretty much. The summary of it was - phase 1 is done and was successful, phase 2 is starting soon. That’s it, so nothing we didn’t already know.

I guess it’s positive that they got some coverage though.

 

If the collaboration is there the Otomagnetics delivery can hopefully be included in the upcoming trials instead of having another go at the FDA-impediment. The info suggests that Otomagnetics uses materials already approved by the FDA. So it would be an opportunity rather than a change in the approach.

 

https://www.wcvb.com/article/local-company-working-on-treatment-to-reverse-hearing-loss/26596728

Frequency Therapeutics is a Massachusetts company hoping to reverse hearing loss using a cutting edge treatment. We first introduced you to the company almost two years ago as it was developing the drug "FX-322."

Humans are born with about 15,000 tiny hairs in each ear, which act like antennas to pick up sound.

Loud noises will kill them off and the human body just throws them away, never to be replaced. Frequency Therapeutics developed a drug they say can convince nearby stem cells to regenerate the destroyed hair follicles. If you can regrow the hair, the belief is you can restore your hearing.

"Really, the goal is to show we can do two things for humans: we can help people hear sound more loudly, and the second half of that is they can hear the sound more clearly," David Lucchino, the co-founder and CEO of Frequency Therapeutics said.

Phase one of the FDA process included injecting 24 patients with a gel during a five minute outpatient procedure last year.

"Phase 1 proved no safety issues and that's all that study was designed to do," Lucchino said. Phase 2 will explore if the drug can be used in multiple doses.

If all goes well, Frequency Therapeutics plans on asking the FDA to fast track the drug, citing recent studies that link hearing loss to other diseases like depression and dementia."

• They are claiming phase 1/2 was just a "phase 1" study... nothing about efficacy .
• Good news is that it was safe! No hyperacusis or other damage to hearing as some have feared.
• "Phase 2 will explore if the drug can be used in multiple doses." -- I guess one dose had some minor effect, but hopefully the effect will be better from multiple injections?

 

Just reading the concept of what they want to do is masturbation material. I swear it gets me hyped and horny everytime I read about how they want to regenerate my hair cells.

 

This could be seen as a negative. Does it mean that the dose they gave didn’t do what they had hoped? And why ”multiple” doses and not simply one larger dose?

Or could it simply be an indicator that phase 2 is planned to include several injections and that it would have been the case no matter what the results in phase 1 were?

So many questions, so many hairs to split...

 

True.

Still. If they had absolutely zero improvement in phase 1, I doubt they would be so cocky to talk about fast tracking the drug (?). They treated enough patients to have a reasonable understanding if the drug works or not with the current injection method.

And remember the $50M cash injection they received in January.

Staying positive

 

It's absolutely normal to try to find what doses are most effective now that they know it's safe, that's the whole point of the phase they're in so don't worry.

I'd be more worried about their top guy leaving for Decibel Therapeutics to be honest but whatever, I don't know enough about the backstabbing that goes on in this corporate pharma world to judge.

 

True, the move is a bit weird. But couldn't it also just be one of these "now I'm needed there and my job here is done" -kind of thing? Where the people at the different companies know each other and collaborate to some extent and swap people around when needed/useful.

Was he a founder/owner or a hired executive?

 

I agree with your logic to some degree, but I think it’s important to note that Frequency Therapeutics for the longest time pushed this whole notion of a single dose administration. They have completely backtracked on this approach. This causes me some concern that the drug isn’t as effective as they were hoping for. This kind of signals to me that they’re going to plan B in hopes that increasing concentration and exposure to the drug will provide the therapeutic benefits they were hoping the initial signal dose administration would have provided.

What are your thoughts on why they’re abandoning the signal dose administration? To me this signals we are in more of a grey area now on whether or not this is going to work. If the single dose method proved to be effective in the 8 individuals who received the high dose then I don’t think we would be seeing them resort to a multiple dose approach as it stands now.

 

It's completely normal that different doses are tried during clinical trials... Yes they wouldn't do that if a single dose restored 100% of the hearing but I don't think anyone expected that?

 

I get that, but I think what I’m trying to say more clearly is this:

David Lucchino mentioned in an interview that a 10 dB improvement is a clinically significant event. I’m guessing they didn’t see this clinically significant improvement happen in the individuals who received the high dose, therefore, they’re resorting to a multiple dose administration to try to achieve this outcome. If a 10 dB improvement was realized in the high dose group then they would currently be sticking to the single dose administration. In my opinion this latest story means they didn’t see at least a 10 dB improvement in any of the individuals, hence the change in direction.

 

Do you guys believe that restoring the hair cells and hearing loss will also solve hyperacusis and other sensitivities such as phonophobia?

 

This could indeed be the case. Another thing that made a warning bell go off for me was the "Phase 1 proved no safety issues and that's all that study was designed to do," -quote, which kind of sounds like they he's trying to cover up the fact that it actually was a phase 1/2 study, where efficiency was taken into account to some degree, because the results just weren't good enough to talk about.

Then again, even if this was the case and the results in the trial was not amazing and over the top, it doesn't necessarily have to mean much. We have to remember this was the first human trial ever for this compound. I'm sure there are a ton of variables they can tinker with and tweak that can potentially change the outcome of the results - things like delivery method, dose size, concentration, etc and even potentially slightly altered version of the compound itself. I assume/hope they have a checklist of potential optimizations they are planning to test.

I keep coming back to this image - If you can have results like this ex-vivo, it simply must be possible to get the same results in-vivo - one way or another.

 

Hope so.

 

Any improvement I believe will help with everything. If I'm severely deaf now and If have to live with this 24/7 then any natural sound increasing has to be easier on the mental side. Of course we’re all hoping for a reversal of hearing loss and maybe that will come as well. If CI implants sometimes lower tinnitus or knock it out then hearing improvement has to do something. That's my theory anyways.

For those who haven't had injections tell the doctor to have a steady hand, after the first one I was face down on the couch in the fetal position all night, he hit my skinny inner ear canal.

For those who had 72 injections, let it be known you're made of metal.

 

When is the next trial? What do we do know? Yes, it's safe, but does it work?

 

Oh my bad. I assumed multiple doses wasn't about several injections but more product injected aka more doses.

The article is blocked in the EU, is "Phase 2 will explore if the drug can be used in multiple doses." a direct quote from Lucchino or the journalist reporting on it?

 

Remember they already said before starting the phase 1/2 that it was only for testing safety, and that, even if they would measure efficacy, it was not designed for this and they were not planning to share the results of the efficacy.

 

I don't understand why people are so worried by by the fact that Frequency Therapeutics will be studying dosage levels in Phase 2. That's what the studies are for and NOW is the time to do it. By the time they get to Phase 3, dosage levels will already need to have been established and it will be too late to go back and experiment!

 

You could be right...

Still, I believe that trying out multiple dosages does not necessarily mean they didn't get 10 dB.

10 dB may be significant... but with regards to people who suffer most (moderate / severe hearing loss), 10 dB may be peanuts.

Imagine what an impact this drug would have if it could restore up to 20-40 dB!

So if I were them... I would use this phase (and my 40 million bucks) to investigate how much damage FX-322 could repair if pushed to the limit. I would try out multiple injections, regardless of reaching the 10 dB or not.

 

When I was in that clinic laying there with goop in my ears I realized that it's not necessarily how much you can inject at one time, but how long it can be in contact with the round window membrane. So if you could use a little and keep it in there longer, that would be better than using a lot that's only in there for a little bit. After my injections he had me lay there with my head perfectly positioned for about an hour every time and I was told not to swallow. Substances injected into the middle ear wash down the eustachian tubes. So if they were injecting a high dose and a low dose and they were only in there for the same amount of time then the essentially I think they would only have had a similar amount of the drug actually diffuse through the round window membrane because that's the bottleneck. Does that make sense?

I'm thinking that for this drug to be really effective that they will have to use multiple doses across days, maybe weeks, and that's what the flaw is with this drug, because I think they want to avoid systemic exposure as much as possible.

 

When do you think this drug will be on the market - and can it help us?

 

Probably at the very very soonest 2 to 3 years.

Yes, for the most part.

 

Do you really think 2 to 3 years? God I truly hope so! I’m scared it’ll fail or disappear somehow though. I have faith something will cure us all, but I’m also afraid!

 

Nothing is for sure, but it is looking like this will in fact recover some hearing loss, and that will likely have a positive impact on tinnitus. The mere fact that they are still moving along with it and getting investments is a good indicator.

That time frame I have proposed would be if everything goes well and they get granted fast track status.