Frequency Therapeutics — Hearing Loss Regeneration

You might be right, but how is it that the researchers don't see that?

 

We haven’t had any results from REGAIN so we don’t know. Frequency Therapeutics has said their drug mostly reaches the freqencies >3.500 Hz. There’s also plenty of research that intratympanic delivered steroids don’t reach the apex.

 

What we do not know is what the effect of four injections will be and why Frequency opted for that. They might have chosen variation in the method of delivery. E.g. dose or exposure time.

 

How do you think they can increase exposure time? They use a gel that ‘rests’ on the round window membrane in order for the drug to permeate in the cochlea. They also haven’t announced anything that makes me think the drug will be longer in the cochlea than in previous trials. The same goes for dosage.

I don’t think they’ll change the delivery method anytime soon. I don’t blame ‘em, right now it’s either oral or intratympanic to get any drug in the cochlea.

 

Do you guys know if they’re still recruiting for their Torrance location?

 

How long did it take for it to go away. I still react to fridges, dryer, water dispenser. Some things cause a ring, others cause a hum.

Best to call.You never know if someone bailed and a spot opened up.

 

3 months or so approximately if I remember correctly. I should really be keeping a journal on this stuff.

My hearing (apart from more mild tinnitus that wasn't reactive) was perfectly normal until early this year, though. Hard to say if it was time or NAD+ but that's all i was consistently taking at the time. It hasn't helped my hearing otherwise, though but my tinnitus no longer seems to react to sounds at all.

 

Good luck and keep us up to date. So far no one from Tinnitus Talk has been accepted for the trials because their hearing loss ain’t that bad.

@ChrisBoyMonkey should be getting his shot soon for OTO-313.

 

They should be, yes.

 

As someone who suffers from hearing loss < 1 kHz, my hope is that targeted drug delivery won't be too far behind a functional drug. If not... I'd be willing to undergo surgical methods (if available) to cram some FX-322 (or something else that works) deep into my apex.

 

Target drug delivery and drug development can run concurrently. Once something better than intratympanic injections comes a long, FX-322 - if approved by then - should be able to utilize that.

 

I mean if this thing worked in vitro and in other mammals, why the hell wouldn't it work in vivo as well?! Makes no sense if it doesn't.

 

Are you allowed to tell us about your trial experience after it happens?

 

Because a lot of science things work fine in a test tube and in rodents, but then end up not working in humans. Never assume something works in humans.

 

I did. I don’t think I’m moving forward with it, to concerned about any possible risks. Maybe wait for phase 3.
Makes me feel like I have the worst tinnitus in the world since none of you guys qualified.

 

Do you think the rats' metabolism increases the circulation of the cochlea faster/better? Maybe we need to hit some blow before the injection to get our heart rates up.

 

Because all kinds of things can go wrong when using it in a live human being. Drug delivery for example.

 

My hearing loss qualifies me, my tinnitus is awful... you are not alone.

I live too far away and I am the breadwinner for my family. I couldn’t risk receiving 4 placebo shots, as well as leaving work and traveling back to the States on top of the fact that none of the trial locations are near my home town or where I have family.

I am surprised that the trials haven’t filled up, they only need 96 patients, volunteers.

in Boston, lab rats were consistently compensated for their time and risk. I wonder why they don’t do that as well as the fact they are still recruiting. You would think the slots would have been filled fast as the USA is so big and has many folks with poor audiograms.

 

Participants are paid for this trial but not for travel, expenses or anything like that.

 

Can you share your audiogram with me if you don’t mind? I still need to get an updated one because mine's like a year old but I feel like my hearing is not bad enough for me to qualify.

 

I don't know. I'm doing OTO-313, and I don't think I've actually signed an NDA yet, but I'll ask next time I'm there.

 

Hi Kain,

Just call the center near you, all the numbers are listed either through Frequency Therapeutics' website or ClinicalTrials.Gov - as I recall it was an 800 number. You can talk directly to the right person who is involved in screening applicants I assume. At ClinicalTrials.gov I believe they post the requirements.

Good luck.

 

They want specific hearing loss in specific bands, and level of tinnitus and hearing loss are not co-dependent.

I have up to 35 dB loss within their 8 kHz range but that wasn't the right loss apparently.

Keep in mind also, the drug isn't listed for tinnitus but hearing loss. Hopefully it improves or eliminates tinnitus.

 

I meet all the listed requirements and don't have any exclusion factors, yet I was still denied. There's more required than they say.

 

I was also denied because my speech understanding scores were not bad enough...

I've had several hearing tests done over the last 2 years...

The interesting thing is when a female with a high pitched tone gives me the test I pass because I do not have high frequency hearing loss, but when someone gives me the test with a lower voice, or if it's done with a male, I score a lot worse on the speech understand part of the test. Because of that, I do not think the standard test is fair. I've also had the tests done at different doctor's offices and there is always a slight variation because they use different testing programs. I really think this is something that should standardize.

 

Maybe they’re aiming for diverse participants within the listed requirements. For example, they could want an even spread between people with mild hearing loss, moderate hearing loss and moderate-severe hearing loss, with you possibly in a category they have ‘enough of’.

 

Did you tell them that? It's possible the female voice was their standard (both male and female "speech in noise" tests exist--I have had both before). Knowing that less of the drug makes it below 3500 Hz, I imagine they would prefer testing FX-322 on those who had trouble with higher pitched speech.

 

This makes a lot of sense and would explain the mysteriousness of their selection process.

 

I almost made it in but my word recognition was too poor, I have severe hearing loss. Plus traveling far to possibly get four fake shots wasn’t appealing anyways. I hate the way they do the placebo group, if you sign up for an experimental drug let me know I’m getting it. This way I can prepare myself and just go for it.

The site also had Otonomy done there but I couldn’t get any clues on it.

 

I think when you get placebo that they give you the real thing afterwards if you want it.