Frequency Therapeutics — Hearing Loss Regeneration

[HootOwl]

My speech-in-noise was thankfully very good as well, so my money is on the bulk of my tinnitus being derived from sudden 16khz hearing loss—OHC/IHC-based, cured by hair cell regeneration.

I go back and forth on this. I believe @FGG mentioned in the past that she's passed speech in noise tests perfectly but needs captions for the TV which is hallmark synaptic damage.

I think those who have tinnitus stemming from syanptopathy could have an extremely mild variety that our brains have unfortunately maladapted to, so I'm hesitant to rule out synaptic damage based on speech in noise tests alone - the same way a 5dB loss in OHC at your tinnitus frequency could still be the source of your tinnitus but under any other circumstance it's considered completely normal and not cause for concern.

But I do hope in your case it's all OHC/IHC! It would be awesome to see you (and others) helped my dude from the very first go around.

 

[mrbrightside614]

I go back and forth on this. I believe @FGG mentioned in the past that she's passed speech in noise tests perfectly but needs captions for the TV which is hallmark synaptic damage.

I think those who have tinnitus stemming from syanptopathy could have an extremely mild variety that our brains have unfortunately maladapted to, so I'm hesitant to rule out synaptic damage based on speech in noise tests alone - the same way a 5dB loss in OHC at your tinnitus frequency could still be the source of your tinnitus but under any other circumstance it's considered completely normal and not cause for concern.

But I do hope in your case it's all OHC/IHC! It would be awesome to see you (and others) helped my dude from the very first go around.

I'd be super surprised if my damage was at the nerve... I have no trouble with clarity of speech and I'd even wager better than people not on a tinnitus board. As @FGG has stated with one of the studies involving mostly deaf people with unusually good speech clarity, there is meaningful information above 8kHz, probably to about 14kHz but that's just a gross estimate. Her losses at the UHF OHCs could account for her inability to understand programs and music. Since the bulk of my asymmetry/"loss" is at 16kHz, the only thing this manifests as is tinnitus. A 10dB improvement sweep above 8khz (which I find to be a conservative estimate considering they didn't measure improvements in the frequencies that would correlate to the region nearest the drug's access) I think would mostly eliminate my T. This is obviously wishful thinking but grounded in theoretical plausibility.

Empirical source: I've been playing the Brain Games TV show, and in one segment, they mismatch visual input with audio input (e.g. the lips animate as if to say the word "fuzz" but the audio input is "buzz") and even when audio/visual inputs try to trick me I'm right about 80% of the time, which is above undamaged contestants' percentage by 30% or more.

 

[FGG]

I go back and forth on this. I believe @FGG mentioned in the past that she's passed speech in noise tests perfectly but needs captions for the TV which is hallmark synaptic damage.

I think those who have tinnitus stemming from syanptopathy could have an extremely mild variety that our brains have unfortunately maladapted to, so I'm hesitant to rule out synaptic damage based on speech in noise tests alone - the same way a 5dB loss in OHC at your tinnitus frequency could still be the source of your tinnitus but under any other circumstance it's considered completely normal and not cause for concern.

But I do hope in your case it's all OHC/IHC! It would be awesome to see you (and others) helped my dude from the very first go around.

Yes, you had that right. I get 100% on speech in Noise test but have a bit of trouble with phone calls and absolutely need captions for media. In real life, I actually have some trouble with speech in noise so I am not sure how good the test is either.

I suspect my cochlear issues might be more IHC related than a true synaptopathy, but who knows?? The only thing I can say is that my normal (up to 8000Hz anyway, since it's very abnormal higher) audiogram does not convey the hearing difficulties i have and neither does the Speech in Noise test.

 

[HootOwl]

Her losses at the UHF OHCs could account for her inability to understand programs and music.

Interesting, so you think UHF OHC loss could in effect manifest itself with the same symptoms as synaptopathy?

I need to think on this a bit... good food for thought.

 

[HootOwl]

So I live in Connecticut where Frequency Therapeutics has their research lab. But unfortunately, the closest clinical trial center to me is in Amherst, NY (6 hours away). I really want to go and visit their research center in person, or give them a call to see if I can somehow receive this revolutionary treatment without having to make that long trip. How likely do you think it is that they may accommodate me? I have been dealing with hearing issues for 5 years now (from 2 Queen concerts presumably), and at the age of 23 it is a bit debilitating. Also, do you think they may add more clinical trial sites for phase 2b and 3?

Thanks everyone in advance for the help!

They actually just added several more testing sites, but I don't think Connecticut is one of them... Either way it doesn't hurt to call them at the NY location. They'll walk you through a phone interview and then ask for you to drop off or fax your audiogram to them. The audiogram is primarily where people are either accepted or rejected it looks like so you'll know before making the 6 hour drive over there.

The research center however can have no part in administering the compound outside of the trial locations. That would be a fairly large violation of FDA protocol - except for expanded use and FX has stated on their website they cannot accommodate EU at this time.

 

[rei]

So I live in Connecticut where Frequency Therapeutics has their research lab. But unfortunately, the closest clinical trial center to me is in Amherst, NY (6 hours away). I really want to go and visit their research center in person, or give them a call to see if I can somehow receive this revolutionary treatment without having to make that long trip. How likely do you think it is that they may accommodate me? I have been dealing with hearing issues for 5 years now (from 2 Queen concerts presumably), and at the age of 23 it is a bit debilitating. Also, do you think they may add more clinical trial sites for phase 2b and 3?

Thanks everyone in advance for the help!

It's not very likely they'll treat you at the lab. I live close to it also, so I've had the same thoughts myself but the reality is that they're a publicly traded company that's going to stick to the rules so they can their drug through the FDA. Also, even if you traveled to New York there's a 50% chance you'd end up getting the placebo. It's frustrating having a possible cure so close but knowing it's out of reach. The only alternative besides waiting would be to rob the lab and kidnap an ENT. I though about it but then I decided to just buy a few shares of their company and wait. Hopefully it won't be long.

 

[FGG]

It's not very likely they'll treat you at the lab. I live close to it also, so I've had the same thoughts myself but the reality is that they're a publicly traded company that's going to stick to the rules so they can their drug through the FDA. Also, even if you traveled to New York there's a 50% chance you'd end up getting the placebo. It's frustrating having a possible cure so close but knowing it's out of reach. The only alternative besides waiting would be to rob the lab and kidnap an ENT. I though about it but then I decided to just buy a few shares of their company and wait. Hopefully it won't be long.

Placebo is only 25% in this study. The remaining 75% have different doses of drug.

 

[rei]

Placebo is only 25% in this study. The remaining 75% have different doses of drug.

Good to know. Are they injecting both ears?

 

[FGG]

Good to know. Are they injecting both ears?

No.

 

[mrbrightside614]

Interesting, so you think UHF OHC loss could in effect manifest itself with the same symptoms as synaptopathy?

I need to think on this a bit... good food for thought.

It's my only guess as to why that one unique population demonstrated such unusually good speech clarity.

 

[Tweedleman]

Will the dosage be tailored to measured OHC loss on a patients audiogram? Will patients likely need repeated doses? I wonder how this will work when purchasing treatment.

I guess what I'm ultimately wondering is: will the goal for the drug be to completely restore the frequencies (that the given formulation can penetrate to) up to perfect hearing thresholds? I really want to believe this drug has the power to improve more than just 10dB, especially where it penetrates most.

 

[Ben S]

I appreciate the feedback, guys. I'm going to contact the Amherst location for some more information.

I think that this drug shows great promise. And perhaps in combination with OTO-413, we can potentially restore our hearing back to the way it once was. Hang in there people, better and brighter times are certainly ahead!

 

[Tweedleman]

I think that this drug shows great promise. And perhaps in combination with OTO-413, we can potentially restore our hearing back to the way it once was. Hang in there people, better and brighter times are certainly ahead!

That hope is the only thing keeping me going. I'm also a concert casualty, having a tremendously hard time accepting what I unknowingly did to my hearing.

 

[Ben S]

That hope is the only thing keeping me going. I'm also a concert casualty, having a tremendously hard time accepting what I unknowingly did to my hearing.

I feel you man, I just wanted to indulge in some awesome music! But keep your head up, and follow the news of FX-332, each day we inch closer to being freed from the shackles of hearing loss, tinnitus, and hyperacusis.

Think ahead to the day where you wake up with no buzzing, ringing, etc., and you hear the perfectly crisp sounds of nature outside your window. I am going to cry tears of joy and give a big ol' kiss to whatever doctor administered the life-changing cure to me (Just kidding).

 

[Ben S]

So from what I understand FX-332 has been effective in restoring IHCs and OHCs. But also, in the video from Frequency Therapeutics it looked like once these hair cells grew back, the nerve endings or synapses (not sure of the proper term) began to grow and reconnect to the cells. Does this mean FX-332 will do what OTO-413 is setting its sights on (fixing synaptopathy)? Could FX-332 indeed fix all noise-induced damage to the cochlea?

 

[FGG]

So from what I understand FX-332 has been effective in restoring IHCs and OHCs. But also, in the video from Frequency Therapeutics it looked like once these hair cells grew back, the nerve endings or synapses (not sure of the proper term) began to grow and reconnect to the cells. Does this mean FX-332 will do what OTO-413 is setting its sights on (fixing synaptopathy)? Could FX-332 indeed fix all noise-induced damage to the cochlea?

No. They have said in their Q and A that if you have intact hair cells, this will not fix a synaptopathy. It only fixes it where hair cells are regrown.

 

[Mitch]

I'm thinking we should gather up the entire Tinnitus Talk community and form an angry mob with torches and pitchforks outside Frequency Therapeutics headquarters.

 

[Ben S]

No. They have said in their Q and A that if you have intact hair cells, this will not fix a synaptopathy. It only fixes it where hair cells are regrown.

Darn. So it looks like I may need more than one kind of treatment. Do you think that the combination of FX-332 and OTO-143 will fix all the types of noise trauma? Or will there still be some kind of noise-induced damage which is not addressed by these two drugs?

I really hope these drugs will work for you too, even though your cochlear damage occurred from a different pathology.

 

[FGG]

I'm thinking we should gather up the entire Tinnitus Talk community and form an angry mob with torches and pitchforks outside Frequency Therapeutics headquarters.

What for exactly?

 

[FGG]

Darn. So it looks like I may need more than one kind of treatment. Do you think that the combination of FX-332 and OTO-143 will fix all the types of noise trauma? Or will there still be some kind of noise-induced damage which is not addressed by these two drugs?

I really hope these drugs will work for you too, even though your cochlear damage occurred from a different pathology.

I have more than just cochlear damage and azithromycin can destroy support cells too. I'm sure I will get some benefit but the noise induced folks should get a lot of benefit addressing those 3 structures imo.

 

[Ben S]

I'm thinking we should gather up the entire Tinnitus Talk community and form an angry mob with torches and pitchforks outside Frequency Therapeutics headquarters.

LOL!

I mean seriously, it's painful that they have the potential cure sitting in there! I wish we could all just line up outside and have a quick, no questions asked injection. Although I'd imagine the line would be like an iPhone release except 100x worse... Still, I would wait and be happy the entire time while in the queue!

 

[Ben S]

I have more than just cochlear damage and azithromycin can destroy support cells too. I'm sure I will get some benefit but the noise induced folks should get a lot of benefit addressing those 3 structures imo.

I hope you find great relief from these upcoming treatments, you have been a great source of information and hope for me (long time lurker), and countless others.

 

[Christopher805]

@mrbrightside614
Yes, I worked quite a number of years there. I am truly honored by your invite. Please let me think about it and get back to you. Also, thank you for the advice to check with my local university for an expanded hearing test. Much appreciated.

If I may, if your group can build an alliance with the veterans, such an alliance will facilitate the group's desire to speed up the grants process to quicker commercialization as well. The reason I say this, is that DoD also issues their own Omnibus SBIR Solicitation. I might add, a very large one.

It will take such an alliance to foster a change in the grants procedures as such a change has to go through a prodigious chain of command. And trust me, there will be detractors on both sides of the fence. Unfortunately, what serves as the best catalyst to change is showing the senseless and unnecessary casualties of any condition. The group would literally have to write the names of each person who is/has suffering/suffered from tinnitus, hyperacusis, Misophonia, etc., and family members affected on a picture and dump them on the halls of congress to pull them from behind the smoking mirrors. Such an action would afford the general populous the chance to see and hear what we have had to endure, which we hope would elicit even more support. It may even make those not affected now see themselves or someone they love possibly succumbing to the condition, which is likely with the steady proliferation of earbud, head phones, etc. in our society.

Before any agency regulation can be changed it has to go through the halls of congress unless there is a federal regulation already in place for said agency to make a change unilaterally.

The group would literally have to carry signs saying I am not INSANE, I am in PAIN.

I pray that TOMORROW is TODAY for a viable cure for us all. It's time well overdue. My ears are calling for attention. Peace.

 

[andreimatei]

Just saw this come out an hour ago: https://www.streetinsider.com/dr/news.php?id=16452241&gfv=1

In googling "form 3" I came up with this:

Form 3 is an SEC filing filed with the US Securities and Exchange Commission to indicate a preliminary insider transaction by an officer, director, or beneficial (10%) owner of the company's securities. These are typically seen after a company IPOs when insiders make their first transactions.​

What do you guys make of this?

 

[mrbrightside614]

@mrbrightside614
Yes, I worked quite a number of years there. I am truly honored by your invite. Please let me think about it and get back to you. Also, thank you for the advice to check with my local university for an expanded hearing test. Much appreciated.

If I may, if your group can build an alliance with the veterans, such an alliance will facilitate the group's desire to speed up the grants process to quicker commercialization as well. The reason I say this, is that DoD also issues their own Omnibus SBIR Solicitation. I might add, a very large one.

It will take such an alliance to foster a change in the grants procedures as such a change has to go through a prodigious chain of command. And trust me, there will be detractors on both sides of the fence. Unfortunately, what serves as the best catalyst to change is showing the senseless and unnecessary casualties of any condition. The group would literally have to write the names of each person who is/has suffering/suffered from tinnitus, hyperacusis, Misophonia, etc., and family members affected on a picture and dump them on the halls of congress to pull them from behind the smoking mirrors. Such an action would afford the general populous the chance to see and hear what we have had to endure, which we hope would elicit even more support. It may even make those not affected now see themselves or someone they love possibly succumbing to the condition, which is likely with the steady proliferation of earbud, head phones, etc. in our society.

Before any agency regulation can be changed it has to go through the halls of congress unless there is a federal regulation already in place for said agency to make a change unilaterally.

The group would literally have to carry signs saying I am not INSANE, I am in PAIN.

I pray that TOMORROW is TODAY for a viable cure for us all. It's time well overdue. My ears are calling for attention. Peace.

Yep, the "chain of command" is an extremely daunting ladder to climb. Take as much time as you need, feel free to PM me. Thanks man.

 

[FGG]

Just saw this come out an hour ago: https://www.streetinsider.com/dr/news.php?id=16452241&gfv=1

In googling "form 3" I came up with this:

Form 3 is an SEC filing filed with the US Securities and Exchange Commission to indicate a preliminary insider transaction by an officer, director, or beneficial (10%) owner of the company's securities. These are typically seen after a company IPOs when insiders make their first transactions.​

What do you guys make of this?

Literally nothing. She's one of their two new hires (she's the new head of HR). It's a required filing.

 

[Jaysterk]

I'm fairly new to all this. Any idea what FX-322 might do for hyperacusis?

 

[mrbrightside614]

I'm fairly new to all this. Any idea what FX-322 might do for hyperacusis?

No clue, not their target. Might help marginally but I have a feeling hyperacusis is more rooted in damage of the nerve rather than in the hair cells.

 

[FGG]

I'm fairly new to all this. Any idea what FX-322 might do for hyperacusis?

I suspect it could help loudness hyperacusis a lot. I'm not sure about noxacusis.

 

[andreimatei]

Literally nothing. She's one of their two new hires (she's the new head of HR). It's a required filing.

Ok. Whew. Awesome. Thank you for this.