Frequency Therapeutics — Hearing Loss Regeneration

What do you think of Otomagnetics?

Their technique could be used to make the small molecules of FX-322 reach the cochlea better than intratympanic injections?

 

Not sure if they do, I guess I’ll never know. I was in the hearing booth for close to 1 and a half hour.

I think their delivery system will not change for a long time, especially if they see something working. I just know Otonomy and FX-322 have people coming in and out so at least there is active movement. They noted Frequency’s trial stuff was very organized. With the FDA fast track, just maybe something will come out of this one.

 

LOL the cochlea is a spiral so you'd have to spin around to get the particles into the apex.

 

Not in this case. I asked.

 

If this is what I am thinking of - they disperse the medicine into a slightly magnetic gel, and then an MRI is used to essentially apply pressure to the gel to get it to disperse in particular directions.

 

Some of their preclinical work showed them safely getting a lot more steroids in the inner ear, and deeper to boot.

 

That's 3 electrons per mitochondria.

 

So is it not possible to fill up the whole Apex using the current method of intratympanic injections?

If they do find out a better method of doing this would they have to do the clinical trials again?

 

I don’t think it works like a bucket of water you can fill entirely. Don’t forget there’s already perilymph in the inner ear you also have to contend with.

No, I don’t think they would have to do separate trials for whatever new drug delivery method becomes available plus any given drug. Drug delivery methods go through their own process for ‘medical devices’ in which of course you have to demonstrate that your method does what it intends to do. But it’s not like you’d have to go through trials for dexamethasone, FX-322, OTO-403 etc. separately. Once a drug delivery method is approved, an ENT can use it.

 

I feel terrible because I really want to volunteer as I have plenty of time and a good schedule (I live in FL and can travel) but there's no way they're going to accept a 22-year-old with 15 dB loss across the 0-8 kHz range.

 

It's been a long time. I was pretty much tinnitus free or highly habituated at least. I got exposed to some very loud music two days ago, so back I've come. I've also been comforted that FX-322 is doing so well. I'm confused as to how they've got a fast track but haven't done 3 phase yet?

Also do you know if they are still taking volunteers?

 

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.

 

@Jurger

Are drug delivery methods quicker to get released?

 

I think it might be possible that the FDA will allow it to skip some phases and get to market sooner if this trial goes well due to military members who get hearing loss from war.

 

That SHOULD be the case as hearing loss is one of the major worldwide health epidemics and hundreds of millions of people have it.

 

Most medical devices are not drug delivery methods so I don’t know. I can imagine they fall within the most strict category. Otomagnetics talked about going from Phase 1 to Phase 3 if they get Orphan status.

 

If you have no diagnosed hearing loss—whether it be through poor quality audiograms, or due to the “hidden hearing loss” phenomenon, would this preclude the patient from access to treatments such as REGAIN or FX-322?

 

Yes, unless they state that it improves tinnitus, it will be hard for specialists to allow you to take the drug.

 

I don't think that question can be answered right now.

 

It would depend on where you live I think. Most countries allow doctors some discretion to prescribe treatments "off-label". They would still have to justify their actions to a higher authority if things went pear-shaped.

 

Probably not. Quite a few people on here were disqualified for not having enough hearing a loss, or "not what they're looking for".

 

It could advance faster than anticipated since it didn't have a phase 1b and went straight to phase 2. There might be some good surprises in 2020 I hope.

 

I disagree. At least once the drug is on the market, I'm sure if it works for tinnitus without hearing loss it will be prescribed off-label for tinnitus but insurance wouldn't cover it in that case.

 

Exactly, like people getting intratympanic dexamethasone now for tinnitus without it being approved.

 

*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.

 

How do you know this?

I could be wrong but I believe this is being tested for SSHL or NIHL.

 

Do you qualify for the trials? Are you going to do it?

 

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

 

If there was no Phase 1b, and it went to Phase 2a, then it could be possible to skip Phase 2b and go to Phase 3.

 

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..)