Frequency Therapeutics — Hearing Loss Regeneration

This shit makes me fucking sick. I hope people like that lose their jobs for saying shit like that. Imagine sufferers who have hearing loss, tinnitus and hyperacusis hear that in person.

I would never wish anyone to have this but they need to look at it from our perspective to realise the suffering that we endure.

 

If you have anything besides ski slope or cookie bite hearing loss, they scratch their heads. All the AuDs I've met arent worth the paper their degree is written on.

 

Hardly surprising though. These are the same people who victim-blame and say these conditions are all in our head. This is what happens of course when something becomes dogma - we can thank Dr Jastreboff for that.

I can’t remember who or when, but someone once posted here an anecdotal story of a conference where they invited a bunch of audiologists and ENTs where they had a round table with a set of headphones connected to a device. They invited attendees to sit down at the table and put on a set of headphones. They played a sound equivalent to a tinnitus sound to see how long people could cope. The most anyone lasted was 7 minutes.

 

I'ts fantastic, let's be honest, FX-322 coming out this year was extremely wishful thinking. 2 years is nothing when you consider that we're very close from seeing how efficient it is and if that's all with flying colours, that motivation alone can carry us through to 2023.

When you look at how long we've been suffering and how long many had to live with hearing loss until the day they died - 2 years is nothing. Let's do this guys!!!!

Let them actually live with this and you'll see how quick their tone would change.

 

Finally listened to it all. Some things that stuck out:

--Dr. Lustig seemed like he wasn't at least fully aware of the new research linking presbycusis to hair cell loss. He had referenced strial loss in his talk before being asked specifically about the new studies linking presbycusis to hair cell loss in the Q and A. His answer was essentially "well, we really don't know..." It came off like a "save" to me for some reason but maybe I am just seeing it through that lens because his tinnitus answer was such an avoidant non answer to me ("who knows, but it would be great!" I mean come on). Not sure if this is relevant, but he was one of the investigators for the Novartis trial so that might damper his general enthusiasm.

--They did mention the problem with Audion is it depletes support cells which is something we figured out on this forum ourselves so there is that (go us?).

--I was surprised they mentioned Pipeline Therapeutics but they did say it has the potential to deplete support cells. I did, at one point, ask Pipeline Therapeutics if this was a concern and they said it doesn't seem to appreciably deplete them. Would love their data on this, but it's possible that's the case as their drug is primarily a synapse drug with a small outer hair cell only effect (supposedly).

--Impressed that people are waking up to the fact that normal audiograms does not at all mean normal hearing. Now if only clinical ENTs and audiologists would tell people that...

 

I honestly don't see the long-term threat from hearing aid companies for regenerative medicine.

Let's take a look at the current supply side of the market:

There appear to be two types of established players in the space: large electronics manufacturers that have a hearing aid division (Siemens, etc) among other electronics divisions and manufacturers of generally only hearing aids (Widex, Oticon, etc). Their client is the audiologist, not the patient.

There are also new entrants challenging the established players with a low-cost product: the over-the-counter "hearables "makers like Nuheara and Bose. Their target is the patient, they cut out the audiologist "middle-man."

Regenerative therapies will obviously create a second challenge front for the established players. If hearing is improved, either patients won't need expensive hearing aides at all, or may be able to move to an over-the-counter alternative.

Here's why I don't see any predatory actions from the established players:

1. The major manufacturers with a hearing aid division won't divert the resources to slow down / dissuade the adoption of regenerative medicine. It's not worth the investment to save a small division of their bottom line. They'll more likely sell the division or scrap it.

2. The hearing aid only manufacturers simply don't have the resources to individually affect the adoption of regenerative medicine by patients, or to affect regulatory decision-making. They may be able to pool collective resources, but that would eventually drive up their product costs making regenerative medicine look more appealing in the long-term.

3. Hearable makers have considerable resources to come in cheaper than regenerative therapies, and continue to take business away from the established players. So, the established players probably don't have the resources to devote to dealing with the over-the-counter problem AND regenerative front effectively. It already seems like hearables are catching up quickly.

4. Insurance, Regulatory, or Governmental interest will put regenerative therapies into a lead-product position. If insurance or Medicare covers FX-322 injections because they're cheaper than hearing aids long-term, game over. If regulators make access to regenerative therapy cheaper in some way, game over. If governments, by way of perhaps the military, start making mass purchases in FX-322 to treat soldiers/veterans, that would be a huge loss to the hearing aid makers. These moves shut the door on hearing aid makers basically permanently. And, if I recall correctly, hearing aid makers are really winning on any of these fronts right now: Insurance doesn't cover hearing aids, new laws have made hearables easy to get, and the DoD has invested in Frequency Therapeutics to push the development of FX-322.

What will likely happen:

1. Hearing aid makers will begin to bankrupt and consolidate to drive costs down and appeal to specialized markets that don't quite benefit enough from regenerative therapy, or not at all.

 

Exciting but at the same time sort of a reality check for time frames.

Pivotal trial in 2022 - Could they start late 2021 though and have it finish in mid 2022? Just like Phase 2 did.

If they finish mid - late 2022 and have it ready at the beginning of 2023 then that's 23 months. Seems like ages but waiting 2 years for possibly the biggest relief you've ever experienced... will be worth it lol.

If they do allow compassionate use I'll jump straight on that though. Does anyone reckon they will do Phase 3 in multiple locations across the world? Frequency Therapeutics did Phase 1 in Melbourne, Australia and I am from Australia. I'd happily sign up for the trial.

Keen for March and May to hear the results of the Phase 2 and then... more waiting XD

 

I can't tell you how much I truly hope these drugs on the horizon like FX-322 work for us, even if it's only partially effective because I think each of us here are going through or have been through our own version of hell, day in and day out.

I know the reality is that there is still so much unknown though, efficacy, release date, cost, availability and so on.

Even if all else fails and we're still here a decade from now, at least we have the support of each other. So to all my fellow sufferers out there, have a great day/night!

 

The Phase 3 will take at minimum a year, and it will be at international sites.

The thing to be optimistic about is IF the Phase 2A, and BOTH Phase 1Bs turn out looking good, the Phase 3 will have access to an ENORMOUS worldwide population, making recruiting relatively quick and easy.

Also, considering how active Frequency Therapeutics is right now with communicating, I expect that they will continue to ramp that up well through the Phase 3. They'll certainly do an interim analysis of the Phase 3; probably more long-term studies of the Phase 2A and 1B patients to keep everyone interested in following along. After all, they need a huge market of patients primed and ready to buy the drug when it gains approval.

 

Why are some of you guys disappointed about pivotal trial being in literally one year?

To me this is very good news. I think some people need to temper their expectations a bit.

 

Tell a bunch of audiologists at a conference that there'll be a cure for hearing loss and 'oh no, we'll be out of a job!' is exactly what they're going to say. It's called banter. There's nothing they can do to stop it and they don't really believe it anyway, so what they say means nothing.

Unless FX-322 really cures hearing loss and doesn't just improve 'clarity', no-one's out of a job anyway. What hearing aids might do is provide the competition to keep FX-322 somewhat affordable, so I suggest we send those hearing aid manufacturers our 'thoughts and prayers' (morally bankrupt money grubbers that they are).

 

I'm not sure either. I think maybe they thought they would start recruiting the day after Phase 2a?

 

Yet these are the same fucks that tell us to just live with it. Audiologists can go down like Blockbuster and Family Video. I've met more useless people in the past year than ever before. I know engineers that could learn to be a Doctor of Audiology in six months I would bet. I skimmed some of the material and compared it to engineering, it's a joke.

 

I was expecting them to start recruitment for the pivotal trial around September or October as results for up to Day 210 come out in May. That's a huge gap between May and Q1/2022.

 

Ah. You were excluding them adding the cohorts from the age-related and severe hearing loss trials. Even then, that would be tight because Phase 3 trials are much more logistically involved but technically doable.

My money is still on the drug coming out in 2023 but there seems to be two main camps: 2023 and 2024 with the extreme pessimists saying even later and the extreme optimists saying 2022 (though that might change after that announcement).

 

In the event today, did they ever mention what would would happen if they would get Breakthrough Therapy designation for FX-322? Once they do get it, they could potentially release the drug out in the market after Phase 2a without waiting for the pivotal trial.

 

Maybe the pivotal trial won’t be as long as Phase 2a. I hope they test up to Day 90 instead of up to Day 210 as this will speed up the process even more.

 

Well they did say that data from this trial would determine the planning for the next (with the FDA). Frequency Therapeutics has every interest in going as quick as reasonable while also making sure they pass their pre-approval meeting AdCom with flying colors.

 

It's a hearing loss drug. The "clarity" thing is to emphasize an unmet need to move things quicker with the FDA.

 

@patorjk @FGG @WickedCarnival @Diesel

Thanks for your input! I actually had my hearing tested at a specialized audiology center, I'll check back with them to ask if they offer audiograms that go up to 16 kHz as well.

Their tests also showed I have a hypermobile eardrum (right ear), for which they referred me to a different specialist.

 

@Lucifer I think we should remain optimistic for I have read directly off the FDA website if the Phase 2 clinical trials show outstanding results (fingers crossed so tight they’re breaking), then it could hit the market much faster than what a normal Phase 3 trial would.

Potentially right after Phase 2. Again, I read that directly from the source.

 

Frequency Therapeutics are certain on doing the pivotal trial though.

Would they even distribute it and sell it if it was approved early?

 

This. It’s pretty obvious that Frequency Therapeutics are choosing their wording carefully. They seem to know exactly what they are doing and how to cover all their bases. I was impressed by the presentation and how organized they are, and that’s only what they are willing to show us publicly too!

 

It’s not certain. They may get Breakthrough Therapy designation which may allow them to release FX-322 straight after Phase 2a instead of after the pivotal trial.

 

They have to set conservative expectations that there is a planned pivotal trial. If the FDA approved the drug early, they will certainly forgo any more trials and get the drug on the market. Frequency Therapeutics is a publicly traded company, trials are extremely expensive and take years to recoup the costs, a product on the market brings positive cashflow to be invested in future products/innovations in the pipeline.

 

Because this phase started in October 2019. That was a year and a half ago. We were supposed to know the results last September/October. I understand the coronavirus messed up their timeline, but we have been waiting a long time. Period.

 

I for one am leaning from cautiously optimistic to moderately optimistic. They are still moving quickly despite the setbacks.

Considering they are planning the Pivotal Trial for 2022, it puts them well ahead of the typical Fast Track timeline for drug development by 2-3 years. So, instead of expecting a product in 2025, it may be closer to 2023 now.

And, there's still that Breakthrough Therapy designation potential still available that could marginally shorten the timeline.

Compare FX-322 to other hearing drugs programs, some have been idle for 5+ years with no end in sight...

 

Yeah, I hear you. But the fullness and ear pain is indescribable to people who haven't experienced sudden hearing loss. It would be one thing just to have tinnitus. That's why I can't stand people who come on here saying oh, it's only one more year.

 

If this cures noise-induced tinnitus, I expect they will recoup their costs in short order based on the VA disability payouts alone?

 

You're right. I'm going to ask about a cochlear implant at the Cleveland Clinic. I can't leave my house and I'm not betting my future on a drug that they have no idea if it works or not.

Unless FX-32 repairs the hair cells and fixes the hearing loss in normal frequencies too, it's a flop.

Do you have constant ear pain with the sudden hearing loss? Mine is deep in the ear and burning constantly.