Frequency Therapeutics — Hearing Loss Regeneration

[Ben S]

It's a bit frustrating to me that Frequency Therapeutics who is based in New England, with two locations, is not hosting clinical trials in freaking New England!! I don't want to drive 6 hours to New York to MAYBE receive the real thing and use up all of my vacation time. And I don't think they let you re-enroll if you receive placebo; well that's the case with Otonomy at least...

 

[Lucifer]

It's a bit frustrating to me that Frequency Therapeutics who is based in New England, with two locations, is not hosting clinical trials in freaking New England!! I don't want to drive 6 hours to New York to MAYBE receive the real thing and use up all of my vacation time. And I don't think they let you re-enroll if you receive placebo; well that's the case with Otonomy at least...

Why don't you sign up and see if you can get accepted for the trials. If you do I would definitely be happy to drive 6 hours to get the shot. I read somewhere it was 75% real drug and 25% placebo.

 

[mrbrightside614]

It's a bit frustrating to me that Frequency Therapeutics who is based in New England, with two locations, is not hosting clinical trials in freaking New England!! I don't want to drive 6 hours to New York to MAYBE receive the real thing and use up all of my vacation time. And I don't think they let you re-enroll if you receive placebo; well that's the case with Otonomy at least...

Honestly, their inclusion criteria is super specific. I'd be surprised if anyone from Tinnitus Talk got admitted into the trials... although by a sheer numbers game it seems like someone would have to.

 

[Ben S]

Why don't you sign up and see if you can get accepted for the trials. If you do I would definitely be happy to drive 6 hours to get the shot. I read somewhere it was 75% real drug and 25% placebo.

I have heavily considered it, but first I would need an extended audiogram. And unfortunately, I am about to start a new job on Tuesday and it's a really big deal for me. (It's a full-time job that I got right after graduating college which pays big). But honestly, I would sacrifice this job if it meant having greatly improved hearing. I would drive to the moon and back if I could have my hearing restored! The problem is, that there's still that 25% chance of not getting the real thing, and that thought is what is making me hesitant. I want to have my old life back, but 6 hours each way for potentially getting nothing is a frightening thought. But I know that this hearing problem is going to affect my job performance, especially since I have to work in teams, and it takes place in the noisy city of Hartford.

I am truly torn on what to do!

 

[Ben S]

Honestly, their inclusion criteria is super-specific. I'd be surprised if anyone from Tinnitus Talk got admitted into the trials... although by a sheer numbers game it seems like someone would have to.

It absolutely is specific. I haven't had an audiogram done in years, I guess that if I want to be included in this study I would need an audiogram that is done 6 months before enrolling... so I suppose I am ineligible until August at the earliest. And also, I want the injection in both ears, but that is not part of the clinical trial... God, I hope this drug hits the market this year... I also wish that OTO-413 would be fast-tracked too so I could have basically all areas of my hearing loss addressed.

 

[Christopher805]

I wish everything was Fast Tracked.

Based on the FX-322 inclusion criteria folks that acquired tinnitus from ototoxins will not be eligible to participate.

 

[Lucifer]

I wish everything was Fast Tracked.

Based on the FX-322 inclusion criteria folks that acquired tinnitus from ototoxins will not be eligible to participate.

FX-322 is currently fast tracked at the moment. If Phase 2a results are positive they might apply for Breakthrough Therapy which would allow them to release the drug into the market. Hopefully this does happen.

 

[Jaysterk]

Based on the FX-322 inclusion criteria folks that acquired tinnitus from ototoxins will not be eligible to participate.

You mean eligible to participate in the trial?

 

[Jaysterk]

It absolutely is specific. I haven't had an audiogram done in years, I guess that if I want to be included in this study I would need an audiogram that is done 6 months before enrolling... so I suppose I am ineligible until August at the earliest. And also, I want the injection in both ears, but that is not part of the clinical trial... God, I hope this drug hits the market this year... I also wish that OTO-413 would be fast-tracked too so I could have basically all areas of my hearing loss addressed.

What does OTO-413 do?

 

[FGG]

It absolutely is specific. I haven't had an audiogram done in years, I guess that if I want to be included in this study I would need an audiogram that is done 6 months before enrolling... so I suppose I am ineligible until August at the earliest. And also, I want the injection in both ears, but that is not part of the clinical trial... God, I hope this drug hits the market this year... I also wish that OTO-413 would be fast-tracked too so I could have basically all areas of my hearing loss addressed.

You don't need an audiogram within 6 months of enrolling. They will repeat the audiogram. You just need two audiograms 6 months apart minimum showing stability. Those audiograms need to be consistent with what they find when they test you at the site.

Ie: you could have audiograms from 3 years ago as long as those don't show instability and then your on site audiogram is consistent (and what they are looking for), I believe you would still qualify.

 

[FGG]

Based on the FX-322 inclusion criteria folks that acquired tinnitus from ototoxins will not be eligible to participate.

Not for the study. In the latest podcast, Kopke said the reason ototoxic folks are usually excluded from trials is there is too much individual variability -- not because drugs can't help them.

 

[FGG]

Where'd you find this?

I just mean since Regain depletes cells we will have some clinical data from the Regain trials on the effects.

 

[FGG]

Honestly, their inclusion criteria is super specific. I'd be surprised if anyone from Tinnitus Talk got admitted into the trials... although by a sheer numbers game it seems like someone would have to.

I would guess someone has. If so, I wish there was a code they could use to hint how the trial is going.

 

[FGG]

It's a bit frustrating to me that Frequency Therapeutics who is based in New England, with two locations, is not hosting clinical trials in freaking New England!! I don't want to drive 6 hours to New York to MAYBE receive the real thing and use up all of my vacation time. And I don't think they let you re-enroll if you receive placebo; well that's the case with Otonomy at least...

It does seem super random. There are actually 4 sites within a few hours from me while all of New England has to travel to upstate NY or Richmond, VA.

Here are all the testing sites:

United States, California
Clinical Trial Site Recruiting
Fresno, California, United States, 93720
Contact: Clinical Trial Information Desk 800-839-9241

Clinical Trial Site Recruiting
Torrance, California, United States, 90503
Contact: Clinical Trial Information Desk 800-839-9241

United States, Colorado
Clinical Trial Site Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Clinical Trial Information Desk 800-839-9241

United States, Florida
Clinical Trial Site Recruiting
Boca Raton, Florida, United States, 33487
Contact: Clinical Trial Information Desk 800-839-9241

Clinical Trial Site Recruiting
Sarasota, Florida, United States, 34239
Contact: Clinical Trials Information Desk 800-839-9241

Clinical Trial Site Recruiting
Tampa, Florida, United States, 33612
Contact: Clinical Trial Information Desk 800-839-9241

United States, Kentucky
Clinical Trial Site Recruiting
Louisville, Kentucky, United States, 40207
Contact: Clinical Trial Information Desk 800-839-9241

United States, Nebraska
Clinical Trial Site Recruiting
Omaha, Nebraska, United States, 68118
Contact: Clinical Trial Information Desk 800-839-9241

United States, New York
Clinical Trial Site Not yet recruiting
Amherst, New York, United States, 14226
Contact: Clinical Trial Information Desk 800-839-9241

United States, North Carolina
Clinical Trial Site Recruiting
Matthews, North Carolina, United States, 28105
Contact: Clinical Trial Information Desk 800-839-9241

Clinical Trial Site Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Clinical Trial Information Desk 800-839-9241

United States, South Carolina
Clinical Trial Site Recruiting
Orangeburg, South Carolina, United States, 29118
Contact: Clinical Trials Information Desk 800-839-9241

United States, Texas
Clinical Trial Site Recruiting
San Antonio, Texas, United States, 78240
Contact: Clinical Trial Information Desk 800-839-9241

Clinical Trial Site Not yet recruiting
San Antonio, Texas, United States, 78258
Contact: Clinical Trial Information Desk 800-839-9241

United States, Utah
Clinical Trial Site Not yet recruiting
Salt Lake City, Utah, United States, 84102
Contact: Clinical Trial Information Desk 800-839-9241

United States, Virginia
Clinical Trial Site Not yet recruiting
Richmond, Virginia, United States, 23235
Contact: Clinical Trial Information Desk 800-839-9241

 

[papu]

I would guess someone has. If so, I wish there was a code they could use to hint how the trial is going.

I don't think anyone active on Tinnitus Talk forum has been in the trial. Even with a non-disclosure agreement, basically nobody here is using their real name.

During the AM-101 trials we had a lot of posts from people participating in the trial (it was a large trial).

So I really don't think anyone active here has gotten into the FX-322 trials.

 

[Joly]

Do you think FX-322 can have an effect on hyperacusis?

How long would it take before becoming available in Europe?

 

[serendipity1996]

It's a shame that supporting cells get depleted with Regain but at least they are trying to get something out in the market to help people.

If Regain comes out first some people will have no choice but to take it.

Do you think FX-322 can have an effect on hyperacusis?

How long would it take before becoming available in Europe?

The upshot is we really don't know at this point. Hyperacusis Research said they had been getting a lot of questions about whether FX-322 would help if successful but the answer is we just don't know.

I think it could also depend on what type of hyperacusis you have - loudness hyperacusis or pain hyperacusis (noxacusis). Re noxacusis, one of the leading theories is that it's essentially a form of neuropathic pain caused by sensitisation of the type 2 nerve fibers in the inner ear. So it's uncertain whether hair cell regeneration would help here.

 

[mrbrightside614]

I just mean since Regain depletes cells we will have some clinical data from the Regain trials on the effects.

Oh, I thought you were talking about phase 2 which IIRC is to be completed in April.

Everyone asking about individual cases, PLEASE read back through this thread. We have covered a lot in the last 10 pages.

OTO-413 has an entirely separate thread dedicated to it; this is not that thread.

 

[FGG]

I don't think anyone active on Tinnitus Talk forum has been in the trial. Even with a non-disclosure agreement, basically nobody here is using their real name.

During the AM-101 trials we had a lot of posts from people participating in the trial (it was a large trial).

So I really don't think anyone active here has gotten into the FX-322 trials.

If anyone reading this qualifies but is discouraged because they live too far away from a site, I will offer them a place to stay for *free. You have to go in weekly or biweekly for a month, I believe but then I think they space it out more (monthly?).

*payment is the annoyance of having to deal with someone asking you if you notice anything is different during the trial.

 

[Serouj]

It absolutely is specific. I haven't had an audiogram done in years, I guess that if I want to be included in this study I would need an audiogram that is done 6 months before enrolling... so I suppose I am ineligible until August at the earliest. And also, I want the injection in both ears, but that is not part of the clinical trial... God, I hope this drug hits the market this year... I also wish that OTO-413 would be fast-tracked too so I could have basically all areas of my hearing loss addressed.

I suggest you wait until August to see the results of the trial. Then make your decision. Well at least you can participate in the trials unlike me since I live in Beirut, Lebanon.

 

[MRItechssuck]

If anyone reading this qualifies but is discouraged because they live too far away from a site, I will offer them a place to stay for *free. You have to go in weekly or biweekly for a month, I believe but then I think they space it out more (monthly?).

*payment is the annoyance of having to deal with someone asking you if you notice anything is different during the trial.

Wait... but NDA... lol. (Just kidding).

No really... a very nice, generous offer to those that need it, and I hope someone will take you up on it.

Why wouldn't air travel be an exclusion... wouldn't the perforated (injection site) eardrum be an issue if I hopped on an airplane an hour after the shot?

I haven't even been able to get a call back, just have gotten answering services for a few clinics... very frustrating

 

[Christopher805]

Not for the study. In the latest podcast, Kopke said the reason ototoxic folks are usually excluded from trials is there is too much individual variability -- not because drugs can't help them.

Thank you FGG.

 

[FGG]

Wait... but NDA... lol. (Just kidding).

No really... a very nice, generous offer to those that need it, and I hope someone will take you up on it.

Why wouldn't air travel be an exclusion... wouldn't the perforated (injection site) eardrum be an issue if I hopped on an airplane an hour after the shot?

I haven't even been able to get a call back, just have gotten answering services for a few clinics... very frustrating

Yeah, you wouldn't want to hop on a flight after an intratympanic injection, that's why I was offering a place to stay for the month-6 weeks (or what not).

 

[Pre55ure]

Wait... but NDA... lol. (Just kidding).

No really... a very nice, generous offer to those that need it, and I hope someone will take you up on it.

Why wouldn't air travel be an exclusion... wouldn't the perforated (injection site) eardrum be an issue if I hopped on an airplane an hour after the shot?

I haven't even been able to get a call back, just have gotten answering services for a few clinics... very frustrating

As long as you can successfully clear your eustachian tube, I don't think it's a problem. I had a number of intratympanic steroid shots, followed up by hyperbaric oxygen therapy only a few days apart which is a much larger pressure differential, and had no problems. I asked the doctors and the techs running the hyperbaric lab and everyone said this shouldn't be a concern and that it's done all the time. So I wouldn't imagine that air travel would be any worse.

(Though an hour later might be pushing it.)

 

[Lucifer]

Has anyone found out what event Frequency Therapeutics is doing in June?

 

[mrbrightside614]

Has anyone found out what event Frequency Therapeutics is doing in June?

Handing out free samples of FX-322 in party favor bags?

 

[GregCA]

Yeah, you wouldn't want to hop on a flight after an intratympanic injection, that's why I was offering a place to stay for the month-6 weeks (or what not).

Why not? If anything, the perforation should help equalize pressure on both sides of the tympanic membrane (even when your ETs aren't working at it via yawing or swallowing).

One typical concern is that the middle ear isn't protected from "the outside" (which is why you shouldn't put water in your ear when you have a perforated ear drum: risk of infection), but I don't know how big of a deal that is in an airplane.

 

[mrbrightside614]

I'm going to repost my speculation from the Woodcock thread because it's more relevant here. These are my legitimate thoughts that I hope will assuage the worries of many tinnitus sufferers. @Candy

I truly think this drug holds more promise for treating tinnitus than it does hearing loss for a few reasons:

1. The participants who were administered the drug in phase 1 had more significant hearing loss (25-60dB @ 250Hz-8kHz) than do most tinnitus-sufferers. This would suggest:

• They probably had more support-cell depletion than people with little-to-no hearing loss.
• They likely experienced improvement in the untested frequencies above 8kHz where I believe the comparatively more intrusive/troubling tinnitus resides.

2. The drug better penetrates the base of the cochlea where HF- and UHF-associated HC's are located.

3. A gel would not discriminate against treating the untested notches of which I believe all tinnitus is composed. I believe the reason why tinnitus sufferers have difficulty matching the exact notch wherein the bulk of their tinnitus resides is because tinnitus is a composite of many untested regions of hearing loss. The bulk of my "loss" is at 16kHz, where there is a 25dB difference in pure tone audiometry between my R & L ear, so 16kHz is my dominant tone; however, when I try to sleep I can better hear the little nuances in the sound of my tinnitus—untested damage of HC's corresponding to 11kHz, 13,455kHz., etc. Indiscriminately sweeping all of these areas with the gel solution should correct the HC's that its surface area contacts.

 

[Momme]

Will FX-322 help me?

"A normal audiogram with the hint of a slight treble reduction. Image closest to presbyacusis of mild kind. Average 16 dB air conduction bilaterally."

 

[ThomasC]

I'm going to repost my speculation from the Woodcock thread because it's more relevant here. These are my legitimate thoughts that I hope will assuage the worries of many tinnitus sufferers. @Candy

I truly think this drug holds more promise for treating tinnitus than it does hearing loss for a few reasons:

1. The participants who were administered the drug in phase 1 had more significant hearing loss (25-60dB @ 250Hz-8kHz) than do most tinnitus-sufferers. This would suggest:

• They probably had more support-cell depletion than people with little-to-no hearing loss.
• They likely experienced improvement in the untested frequencies above 8kHz where I believe the comparatively more intrusive/troubling tinnitus resides.

2. The drug better penetrates the base of the cochlea where HF- and UHF-associated HC's are located.

3. A gel would not discriminate against treating the untested notches of which I believe all tinnitus is composed. I believe the reason why tinnitus sufferers have difficulty matching the exact notch wherein the bulk of their tinnitus resides is because tinnitus is a composite of many untested regions of hearing loss. The bulk of my "loss" is at 16kHz, where there is a 25dB difference in pure tone audiometry between my R & L ear, so 16kHz is my dominant tone; however, when I try to sleep I can better hear the little nuances in the sound of my tinnitus—untested damage of HC's corresponding to 11kHz, 13,455kHz., etc. Indiscriminately sweeping all of these areas with the gel solution should correct the HC's that its surface area contacts.

Do we know if participants in phase 1 had tinnitus? Is it mentioned somewhere?