Frequency Therapeutics — Hearing Loss Regeneration

[FGG]

Forgive me if I am mistaken, but did you not list your cause of tinnitus as Ménière's?

Yes. My original otologist diagnosed me with Meniere's based on having both vestibular signs and hearing loss. It has since been ruled out by much more thorough Otologists because:

A) My electrocochleagram was normal after all but incredibly the first Otologists didn't read the results and assumed it was abnormal (yes, really).

B) I had a history of Lyme disease from 2005 and that can produce a Meniere's-like hydropic disease and again an assumption was made by the first otologist.

In any case, my hearing loss was timed with high dose antibiotic use (was being trial-treated for Lyme when I had the vestibular episodes with no known cause) not the vestibular episodes.

Truthfully, I didn't get a thorough workup until I went to OK in June. My new Otologist highly doubts--if not completely ruled out Meniere's--because of many factors including normal imaging, normal Electrocochleagram x 2, and most importantly, my hearing loss was not at all timed with vestibular issues. For instance, I had a 48 hour continuous rotational vertigo attack last fall and had no tinnitus, ear fullness or loss. Those happened after high dose antibiotics.

It appears i was misdiagnosed and it's likely the "Meniere's" was from something else (vestibular migraines?). I haven't had a vertigo attack since April as well.

I think I have two separate issues which less thorough drs never like: ototoxicity and vestibular migraines (which have gotten much better).

 

[FGG]

That sounds more like neuropathy, but it's strange your audiogram is fine. What did your otologist say? Might it be a somatic issue?

He's still doing more research. It's definitely at least partially in my cochlea because I had ear fullness and sunburn type ear pain when it first happened and then a "live high wire" electrical type sound for a week with an accompanying strange intermittent ear sensation.

 

[JohnAdams]

can't he offer sustained-exposure BDNF treatments as well

What?

 

[JohnAdams]

Ey guys, it's great that FX-322 got fast track status. Shouldn't we be optimistic now about it because it restored hearing in mice? That makes it a 99% chance that it will work in humans, right?

Yes, we have everything to be optimistic about here. We know it works on human tissue and it improved hearing fidelity with just one dose. Also there was a guy in the Regain trials, which is also based on hair cell regeneration, that claimed his tinnitus and hyperacusis improved. Anyone telling you to not be optimistic is just an idiot. Don't listen to them. The evidence that we have thus far points to at least partial improvement.

 

[InfiniteLoop]

Just got rejected for the FX-322 phase 2 clinical trial in California. Not enough hearing loss in the human communication range (standard audiogram).

 

[Jurger]

Ey guys, it's great that FX-322 got fast track status. Shouldn't we be optimistic now about it because it restored hearing in mice? That makes it a 99% chance that it will work in humans, right?

Fast track status is not a signal the drug is super effective. It's meant for drugs with promising results that address serious illnesses.

And no, I don't buy the 99% chance. Plenty of drugs showed promising results in in vivo work or even human trials, only to still fail in Phase 3. Hell, there've been drugs that passed Phase 3a only to fail in Phase 3b. The fact is this drug improved 10 dB at 8000 Hz for 4 out of 15 patients that got it. It also improved their word scores. That's it. Roughly 75% didn't improve as far as we know. Maybe multiple injections will do better because the duration of the drug in the cochlea will be extended. That's something we don't know yet.

I'm cautiously optimistic but will resist the urge to use this drug as a coping mechanism. We are still at the beginning of finally reaching one of the most elusive goals in all of medicine.

 

[Gorbeh3]

PSA:

If you are participating in this trial, you will need to make at least 12 trips to the testing center, possibly more.

Additionally, you won't receive more than $700-$900 as reimbursement for participating.

As someone who lives in the northeast, I was interested, but these facts withstanding put it out of reach.

As badly as I want this, I can't justify 12 airplane trips ($3K- $4K at least) and 12 days of my life, especially with a 25% chance of placebo & on my own dime.

If you don't live within a two hour drive of the testing center, it probably isn't worth it, we are going to have to wait another year until phase 2B? 3A?

Hang in there guys.

 

[Jurger]

PSA:

If you are participating in this trial, you will need to make at least 12 trips to the testing center, possibly more.

Additionally, you won't receive more than $700-$900 as reimbursement for participating.

As someone who lives in the northeast, I was interested, but these facts withstanding put it out of reach.

As badly as I want this, I can't justify 12 airplane trips ($3K- $4K at least) and 12 days of my life, especially with a 25% chance of placebo & on my own dime.

If you don't live within a two hour drive of the testing center, it probably isn't worth it, we are going to have to wait another year until phase 2B? 3A?

Hang in there guys.

Thanks for the info. Usually they offer to give you the drug after the trial if you've gotten the placebo.

 

[FGG]

Usually they offer to give you the drug after the trial if you've gotten the placebo.

This is not the case with FX-322 I was told.

 

[JohnAdams]

PSA:

If you are participating in this trial, you will need to make at least 12 trips to the testing center, possibly more.

Additionally, you won't receive more than $700-$900 as reimbursement for participating.

As someone who lives in the northeast, I was interested, but these facts withstanding put it out of reach.

As badly as I want this, I can't justify 12 airplane trips ($3K- $4K at least) and 12 days of my life, especially with a 25% chance of placebo & on my own dime.

If you don't live within a two hour drive of the testing center, it probably isn't worth it, we are going to have to wait another year until phase 2B? 3A?

Hang in there guys.

Dude, you got this. Go for it.

 

[hopeful4future]

Just got rejected for the FX-322 phase 2 clinical trial in California. Not enough hearing loss in the human communication range (standard audiogram).

What do you mean as far as the human communication range? I have the 1st screening scheduled for the phase 2. I have to travel a decent ways. I don't fee like I have trouble communicating with people. This makes me wonder if the trip is worth it.

 

[Mitch]

Do you guys think low-level laser therapy (for example, Dr. Wilden's) could help in this kind of situation?

LLLT is unfortunately useless for treating tinnitus. I learned this the hard way.

Just got rejected for the FX-322 phase 2 clinical trial in California. Not enough hearing loss in the human communication range (standard audiogram).

I want to apply but I fear I would be rejected too because I have negligible hearing loss, and the hearing loss that I have seems to be above 13 kHz (very high pitch).

 

[ChrisBoyMonkey]

Ey guys, it's great that FX-322 got fast track status. Shouldn't we be optimistic now about it because it restored hearing in mice? That makes it a 99% chance that it will work in humans, right?

It has already started showing signs that it does work in humans.

 

[Rb86]

Just got rejected for the FX-322 phase 2 clinical trial in California. Not enough hearing loss in the human communication range (standard audiogram).

How much hearing loss is needed? I thought too much hearing loss was the deal breaker, not not enough. You'd think they'd want you more as you're an "easier" fix.

 

[Rb86]

I have to say, for a company that is WELL funded, Frequency Therapeutics is shit for communication with the hearing loss/tinnitus community. I mean really.

Hough Ear Institute is night and day better. One could argue that's because Hough Ear Institute needs the money and public donations, but hey, Frequency Therapeutics is publicly traded and would do more if they had practically any PR.

They're trialing in my town and I can't get a call back.

 

[Lucifer]

How much hearing loss is needed? I thought too much hearing loss was the deal breaker, not not enough. You'd think they'd want you more as you're an "easier" fix.

I agree. They should test it on people that do not have enough hearing loss to see how many doses this person needs to fix the problem.

 

[Daniel Lion]

This is not the case with FX-322 I was told.

Hi FGG,

Told by whom?

If that's ok to ask. This has been an important question for me. Thank you.

 

[Daniel Lion]

I agree. They should test it on people that do not have enough hearing loss to see how many doses this person needs to fix the problem.

That is completely illogical to me, by the way.

That just makes no sense to me for so many reasons... I am glad it's being tested in moderate to severe cases, as this will really provide clearer evidence of efficacy of multiple dosing, illuminate the problem of reaching the desired parts of the cochlea, and of course for selfish and unselfish reasons of helping people avoid cochlear implants and people who can't use hearing aids because of hyperacusis but suffer from profound hearing loss.

In terms of science it seems the better way forward to me... I don't feel I articulated this well but my instinct tells me it's better to start with more severe cases as a way of determining doses for FX-322.

Member @Jurger made a very good point about this being one of the "most illusive goals in modern medicine" .
I remain hopeful that we could benefit from this technology in this lifetime.

FGG's audiogram is so much better than mine but our day to day hearing challenges are so different. This is truly a sad and complicated condition amongst many others that modern medicine is unable to solve.

@Rb86... what's up.... as far as FX-322 being compared to Hough... I am not sure I agree with you. I like Hough and that the director is volunteering in Vietnam... but I am biased... FX-322 is drawing from MIT and Harvard... That's 1st division. If you track 75% of the tech the military, NASA uses today, it will lead you back to MIT, even much of the computer digital revolution. 75% is a number I made up, but all the defense crap, lasers, tracking units, is coming from Raytheon which is a spin off of MIT.

I digress, I may very well may be wrong and often am... I see it like MLB as opposed to amateur baseball. Just me riding a hunch, gut instinct. I wish Stanford and Dr. Heller's team would jump in the game and bring something to market... it just shows you how complicated this stuff is.

Peace out.

 

[Caveman]

LLLT is unfortunately useless for treating tinnitus. I learned this the hard way.

I want to apply but I fear I would be rejected too because I have negligible hearing loss, and the hearing loss that I have seems to be above 13 kHz (very high pitch).

Can I ask you what laser did you use? Some people claim that after LLLT their audiograms have improved... so it's possible that the treatment doesn't give relief from tinnitus but improves hearing nonetheless.

 

[Jurger]

How much hearing loss is needed? I thought too much hearing loss was the deal breaker, not not enough. You'd think they'd want you more as you're an "easier" fix.

25-70 dB in the 250-8000 Hz range. The restoration of hearing in the ultra high frequencies (>8000 Hz) is only a secondary outcome measure. That means they aren't recruiting patients now that only have hearing loss >8000 Hz, but will check if the drug restores hearing in the >8000 Hz frequencies in patients that have <8000 Hz hearing loss.

And we don't know what's their reasoning for having >8000 Hz restoration as a secondary outcome measure. Maybe they're screening for a new patient population. Maybe they're using it to confirm patients who didn't have their hearing <8000 Hz restored is due to the drug not reaching those areas of the cochlea. If patient X gets no results <8000 Hz but does get results >8000 Hz the problem is probably not the drug, but the drug not reaching certain areas of the cochlea.

 

[JohnAdams]

LLLT is unfortunately useless for treating tinnitus. I learned this the hard way.

@Artemis2K

 

[JohnAdams]

Why is it so hard for people to see that most tinnitus cases from damage are phantom limb syndrome of the inner ear?

 

[FGG]

Hi FGG,

Told by whom?

If that's ok to ask. This has been an important question for me. Thank you.

One of the coordinators when I asked this question at my screening appointment.

 

[Daniel Lion]

One of the coordinators when I asked this question at my screening appointment.

thanks FGG........take care.....

 

[incelitus]

This thread gives me so much hope.

I always come back to it when I'm feeling down and in need of motivation to keep going.

 

[GlennS]

One could argue that's because Hough Ear Institute needs the money and public donations

This. And you have to be cautious about this sort of thing.

 

[Time4fix]

@JohnAdams am I wrong to remember that at a certain point in time you believed FX-322 might not help people with a rather normal audiogram (including yourself), but who suffer mostly from synaptopathy? Has that view changed or returned to your initial thought? Because I do still see synaptopathy as the culprit for many people and I'm not sure if FX-322 will be as effective for this. I do see how it could return some input and maybe that way make up for the synaptopathy.

Also, what is considered "damage"? Will FX-322 replace every cell with the tiniest bit of damage or does the damage to the cell have to be moderate or severe? Might not be known but I guess I'll just ask anyways because this forum seems to be very helpful and knowledgeable.

 

[Caveman]

@JohnAdams am I wrong to remember that at a certain point in time you believed FX-322 might not help people with a rather normal audiogram (including yourself), but who suffer mostly from synaptopathy? Has that view changed or returned to your initial thought? Because I do still see synaptopathy as the culprit for many people and I'm not sure if FX-322 will be as effective for this. I do see how it could return some input and maybe that way make up for the synaptopathy.

Also, what is considered "damage"? Will FX-322 replace every cell with the tiniest bit of damage or does the damage to the cell have to be moderate or severe? Might not be known but I guess I'll just ask anyways because this forum seems to be very helpful and knowledgeable.

We all know that the main symptom of synaptopathy is losing the ability to hear clearly when there is a noisy background... According to the results of the Phase 1/2 study, it seems that FX-322 improves speech-in-noise understanding so I guess it regrows both hair cells and their synapses, to some extent!

 

[JohnAdams]

@JohnAdams am I wrong to remember that at a certain point in time you believed FX-322 might not help people with a rather normal audiogram (including yourself), but who suffer mostly from synaptopathy? Has that view changed or returned to your initial thought? Because I do still see synaptopathy as the culprit for many people and I'm not sure if FX-322 will be as effective for this. I do see how it could return some input and maybe that way make up for the synaptopathy.

Also, what is considered "damage"? Will FX-322 replace every cell with the tiniest bit of damage or does the damage to the cell have to be moderate or severe? Might not be known but I guess I'll just ask anyways because this forum seems to be very helpful and knowledgeable.

Excellent question. I think those of us with synaptopathy also have hair cell damage. If a regenerated hair cell causes synapses to regrow and reconnect, wouldn't that type of damage heal without loss of the hair cell on its own?

In my case, I am not so sure. I am having a fantastic day with probably the lowest tinnitus and the clearest hearing I have had in a very long time. So for me, I don't know if my tinnitus is from loss of hair cells per se, because it's like a see saw, low tinnitus, clearer hearing, no hyperacusis. When it flares up, I have poorer hearing and sometimes hyperacusis. So perhaps for me it is in fact more of a synapse issue.

 

[Caveman]

Excellent question. I think those of us with synaptopathy also have hair cell damage. If a regenerated hair cell causes synapses to regrow and reconnect, wouldn't that type of damage heal without loss of the hair cell on its own?

In my case, I am not so sure. I am having a fantastic day with probably the lowest tinnitus and the clearest hearing I have had in a very long time. So for me, I don't know if my tinnitus is from loss of hair cells per se, because it's like a see saw, low tinnitus, clearer hearing, no hyperacusis. When it flares up, I have poorer hearing and sometimes hyperacusis. So perhaps for me it is in fact more of a synapse issue.

Then you might be interested in some supplements which can increase the concentration of BDNF and NT-3 in your bloodstream...