Frequency Therapeutics — Hearing Loss Regeneration

[Jurger]

I asked because getting the disease under control is a nightmare. For people with autoimmune inner ear disease, they basically need high dose steroids all of the time. There's going to be periods where they have to get off steroids for their health. I was mostly trying to better understand how the drug worked. But yeah, I certainly agree that one's strategy shouldn't be to take FX-322 every day.

Do intratympanic steroid injections work?

 

[sensualmosquito]

Do intratympanic steroid injections work?

It's really all we have at this point, I know for acute acoustic trauma like mine they use it basically because there's nothing else to really do. Sometimes it works and sometimes it doesn't, and there are not really any trials that have been done as far as I know regarding its efficacy.

 

[Zugzug]

Do intratympanic steroid injections work?

My understanding is that they are adjunctive therapy, but with mixed results.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6383306/

 

[GlennS]

I would take a punt and say that this treatment would fall in this category since it is very safe and it is also a treatment which will enhance people's lives. Therefore I can see it getting Fast Tracked and being out there in a year or so.

One thing I liked about the Tinnitus Talk Podcast interview is that Carl LeBel said they are trying to fast-track it rather than having this sit in the lab for decades being tested to death. This is in contrast to, let's say Susan Shore. Not that this couldn't backfire (ahem, Neuromod)...

 

[FGG]

My understanding is that they are adjunctive therapy, but with mixed results.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6383306/

View attachment 39991

Your link mentions oral steroids being generally effective for AIED so IT steroids don't often add much additional benefit. The effects of steroids on AIED are transitory, however, but this is the exact problem Otonomy is trying to address with Otovidex.

What makes you think you have AIED btw? Did you finally get a diagnosis? You mentioned recently your audiogram was good. Normally you'd be losing hearing if you weren't on immuno suppressive therapy.

 

[Zugzug]

What makes you think you have AIED btw? Did you finally get a diagnosis? You mentioned recently your audiogram was good. Normally you'd be losing hearing if you weren't on immuno suppressive therapy.

I am more confident (in fact, very confident) that I have autoimmune-induced hyperacusis/tinnitus than I am that I have AIED in the classical sense. I do not have a diagnosis, and the reason is that I'm borderline for Sjogren's based on objective evidence, but am unable to make it to my appointments to have my lip biopsied. My hyperacusis is very, very severe. Like, with earplugs and earmuffs in, extremely soft noises bother me such as writing, typing, etc. I do not feel ready to get in a car right now.

Anyways, I realize this is a tinnitus forum so I don't really talk about it, but I had very obvious chronic illness in the five years leading up to my hearing problems. I had to take a semester off of grad school where I was extremely sick. Pain everywhere, fatigue, neuropathy, stomach problems, dryness, tons of eye floaters (suddenly). Even when I came back, I felt horrible all of the time. Those five years play a big role in my opinions of this problem. If I was otherwise completely normal and the hyperacusis popped up, I would be more skeptical.

You are right though; it's very strange that I don't have profound hearing loss yet -- especially at the 14 month mark. That's basically unheard of with AIED. I have a couple of theories for this:

1) I don't have AIED. Something else is damaged, but it's not related to hair cells.
2) I do have AIED, but my brain is reactive to the hearing loss, giving me hyperacusis.

I would be amazed if the biopsy was negative, as it would point towards something else. If this isn't autoimmune, I don't know what else it could be.

 

[FGG]

I am more confident (in fact, very confident) that I have autoimmune-induced hyperacusis/tinnitus than I am that I have AIED in the classical sense. I do not have a diagnosis, and the reason is that I'm borderline for Sjogren's based on objective evidence, but am unable to make it to my appointments to have my lip biopsied. My hyperacusis is very, very severe. Like, with earplugs and earmuffs in, extremely soft noises bother me such as writing, typing, etc. I do not feel ready to get in a car right now.

Anyways, I realize this is a tinnitus forum so I don't really talk about it, but I had very obvious chronic illness in the five years leading up to my hearing problems. I had to take a semester off of grad school where I was extremely sick. Pain everywhere, fatigue, neuropathy, stomach problems, dryness, tons of eye floaters (suddenly). Even when I came back, I felt horrible all of the time. Those five years play a big role in my opinions of this problem. If I was otherwise completely normal and the hyperacusis popped up, I would be more skeptical.

You are right though; it's very strange that I don't have profound hearing loss yet -- especially at the 14 month mark. That's basically unheard of with AIED. I have a couple of theories for this:

1) I don't have AIED. Something else is damaged, but it's not related to hair cells.
2) I do have AIED, but my brain is reactive to the hearing loss, giving me hyperacusis.

I would be amazed if the biopsy was negative, as it would point towards something else. If this isn't autoimmune, I don't know what else it could be.

Ahhh. Okay this makes way more sense. AIED is defined as "when the body's immune system attacks cells in the inner ear that are mistaken for a virus or bacteria" (found that definition online and it is nice and simple and clear but a bit general). It leads to rapid hearing loss because the inner ear structures are the primary target.

What you suspect is you have a more systemic autoimmune disease and the inflammation contributes to your ear pathology.

Have you seen a rheumatologist? In some cases, biologics might really help (in fact I think there is a clinical trial using Embrel to treat tinnitus) because if you lower your TNF alpha and other systemic mediators of inflammation in the body as a whole, there would much less aberrant immune stimulation, including in your ear. You need a specific diagnosis to get the best treatment for this.

 

[Xojo]

100% with you on the music aspect. Personally, the hardest part of this entire experience was having to stop playing in bands/listening to music. I went from playing guitar around 6 hours a day on average to not picking it up in months. Music was quite literally my life.

Same here. I used to work on music every week, but now I rarely write or even listen to music anymore. It doesn't sound that good and I am too afraid of damaging my ears further. Also, remembering how much better everything used to sound makes me more depressed.

 

[Zugzug]

What you suspect is you have a more systemic autoimmune disease and the inflammation contributes to your ear pathology.

I definitely suspect I have a systemic autoimmune disease driving the problem. What's strange is that right when my ear problems began, which actually started out as balance problems, many of my other symptoms disappeared. For example, since getting hyperacusis, I've been pain free for the first time in years. It seems like my inner ear is almost the entire focus. In that regard, it seems like I have AIED, as opposed to just residual inflammation. But I don't have hearing loss. It makes no sense to me. My rheumatologist says I may have AIED, but I think we're all kind of confused. I will ask him about biologics and TNF-alpha.

 

[FGG]

I definitely suspect I have a systemic autoimmune disease driving the problem. What's strange is that right when my ear problems began, which actually started out as balance problems, many of my other symptoms disappeared. For example, since getting hyperacusis, I've been pain free for the first time in years. It seems like my inner ear is almost the entire focus. In that regard, it seems like I have AIED, as opposed to just residual inflammation. But I don't have hearing loss. It makes no sense to me. My rheumatologist says I may have AIED, but I think we're all kind of confused. I will ask him about biologics and TNF-alpha.

Your diagnosis rodeo sounds like how mine started. I had severe nerve pain too. Easily 8-9/10 in my case. Bad enough where I ended up on Buprenorphine for a few months. Mine also disappeared around when I started having balance problems.

I had full rotational vertigo attacks starting fall of 2018. They were fully incapacitating, I couldn't open my eyes or move my head an inch without vomiting. My longest one lastest 48 hours and, in fact, my right vestibular nerve is pretty much non functional. The fact that I have decent enough balance again and can walk completely unaided shows how powerful neuroplasticity is but anyway...

At first I was told it was vestibular migraines then Lyme or Meniere's depending which doctor I asked. I had a history of Lyme 15 years prior. At this time my hearing was 100% normal. After they put me on high dose antibiotics for Lyme and a possible Babesia co-infection, I lost my hearing bilaterally at the same time. Doctors then said Meniere's because the antibiotics didn't help my balance despite me questions why Meniere's would have exactly symmetrical hearing loss and i had no loss before antibiotics.

I eventually got a diagnosis of ototoxicity after an extended audiogram because the losses were so symmetrical and my history of course and the fact that my hearing and tinnitus didn't fluctuate.

Turned out my balance and nerve pain was viral (Epstein Barr in my case). My nerve pain resolved before antivirals but I was having vertigo attacks every month and I haven't had one since starting Acyclovir. My last attack was April of 2019, in fact.

Is it possible yours has a viral component? Some of the weirdest vestibular/hearing stuff is sometimes viral. Might be good to at least rule that out since infections are definitely linked to autoimmunity as well.

 

[Zugzug]

At first I was told it was vestibular migraines then Lyme or Meniere's depending which doctor I asked. I had a history of Lyme 15 years prior. At this time my hearing was 100% normal. After they put me on high dose antibiotics for Lyme and a possible Babesia co-infection, I lost my hearing bilaterally at the same time. Doctors then said Meniere's because the antibiotics didn't help my balance despite me questions why Meniere's would have exactly symmetrical hearing loss and i had no loss before antibiotics.

I eventually got a diagnosis of ototoxicity after an extended audiogram because the losses were so symmetrical and my history of course and the fact that my hearing and tinnitus didn't fluctuate.

Turned out my balance and nerve pain was viral (Epstein Barr in my case). My nerve pain resolved before antivirals but I was having vertigo attacks every month and I haven't had one since starting Acyclovir. My last attack was April of 2019, in fact.

Is it possible yours has a viral component? Some of the weirdest vestibular/hearing stuff is sometimes viral. Might be good to at least rule that out since infections are definitely linked to autoimmunity as well.

That's quite interesting. There are several things that are unusual that our stories share.

1) Bilateral to the point of symmetric. From what I've read, symmetry is generally a sign of autoimmunity, and that viruses tend to affect one ear. How did you conclude that Epstein Barr was the root of the bilateral issues? Seems pretty surprising.
2) Pain that completely transitioned to ear issues. I have never heard of anyone else experiencing this. There are a lot of people with autoimmune problems who develop ear issues on top of their problems, but rarely this obvious transition.

I've been tested for Epstein Barr, lyme, syphilis. I've also tried L-Lysine, which did not help. My balance issues were very different. There were no episodes; it was 100% constant at all times. When I would walk, I would feel drunk. Fortunately, it was never so bad that I couldn't move without throwing up, but at the same rate, it was super obvious that something was wrong. I also had tinnitus and the beginning of hyperacusis. I do believe that the reason they have resolved is because of neuroplasticity. Also, I've tried Doxycycline and it didn't make things worse. The lack of ototoxicity makes me question hair cells as well.

If I pretty conclusively test negative for Sjogren's, I may try acyclovir. I would be surprised if it helped when L-Lysine did not.

EDIT: I think I misunderstood you. The Epstein Barr was not responsible for the symmetry; the ototoxicity was.

 

[patorjk]

Any thoughts on what the next 2 months will hold? Frequency Therapeutics initially said they were releasing top-line results at the end of September, but that seems like it now may be delayed.

Also, in the Tinnitus Talk Podcast, Carl LeBel mentioned that they were monitoring the patients (but were blinded to who was who) for safety reasons. Do you all think they could be doing that for the Phase 2a study too? I would think there would be a conflict of interest since they hold stock in the company, but maybe those who see the data can't sell or buy shares. And if some of them can see the data, I wonder if Carl LeBel is one of those individuals.

 

[Diesel]

Any thoughts on what the next 2 months will hold? Frequency Therapeutics initially said they were releasing top-line results at the end of September, but that seems like it now may be delayed.

Also, in the Tinnitus Talk Podcast, Carl LeBel mentioned that they were monitoring the patients (but were blinded to who was who) for safety reasons. Do you all think they could be doing that for the Phase 2a study too? I would think there would be a conflict of interest since they hold stock in the company, but maybe those who see the data can't sell or buy shares. And if some of them can see the data, I wonder if Carl LeBel is one of those individuals.

I would temper any expectations for an update on-or-shortly after the Sept. 30 deadline. I would be delighted to see either a top-line report or interim analysis by year-end, though. It's possible Frequency has already received an interim analysis, but not publicly disclosed it. Could be a reason for the $42MM private placement out-of-nowhere, mid-trial.

Realistically, Q1-2021 seems most likely if they are indeed only just over half-participation (assuming 50 participants) as of June, 2020.

If I understand how a Clinical Trial is setup, the care provider monitors the safety of participants, not Frequency. The trial can be halted by the sponsor if the care providers report enough adverse events. At this point, based on what we know about the participant rate, 20 - 30 should have exited or nearly-exiting the trial. So, they've had all 4 doses of FX-322 / placebo + continued testing visits for at least the past 5 months.

The good news here is that one might imply that the safety profile continues to be favorable for the participants in the Phase 2A, and that they have handled multiple doses of FX-322 (and/or placebo) without any major issue. So, get those ear drums ready!

 

[Lucifer]

Any thoughts on what the next 2 months will hold? Frequency Therapeutics initially said they were releasing top-line results at the end of September, but that seems like it now may be delayed.

Also, in the Tinnitus Talk Podcast, Carl LeBel mentioned that they were monitoring the patients (but were blinded to who was who) for safety reasons. Do you all think they could be doing that for the Phase 2a study too? I would think there would be a conflict of interest since they hold stock in the company, but maybe those who see the data can't sell or buy shares. And if some of them can see the data, I wonder if Carl LeBel is one of those individuals.

I hope they release Phase 2a clinical trial results by October at the earliest. I can't wait for the positive results to come out.

 

[Tweedleman]

I used to work on music every week, but now I rarely write or even listen to music anymore. It doesn't sound that good and I am too afraid of damaging my ears further. Also, remembering how much better everything used to sound makes me more depressed.

Same here, soooo much. I listened to music on the way to work in the truck, at work (just playing it off of my phone with surprisingly good quality), and finally after work I'd smoke up and delve into more music, constantly searching for new bangers and building playlists.

Music fueled me more than any substance, my life revolved around it. And then came the collecting; vinyl, CD, and band shirts. I even have a limited edition black metal album that came with corpsepaint. Fucking kills me to look at it all now. I spent thousands and it's all in duffle bags now.

Immediately after my trauma music sounded tinny and soulless, like someone just sucked all of the bass and soul out of it. My cell phone audio all of a sudden sounded like crap, and only the ear that was on the side of the pocket my phone was in could hear the sound clearly. My low freq hearing was down 25 dB at the time, but has somehow recouped up to 10 dB. Still, nothing sounds as good as it used to before the trauma. And while cannabis used to enhance the listening experience, it now just spikes my tinnitus and draws attention to the uneven hearing.

I left my noisy job 'officially' due to the sound sensitivity and tinnitus, but the truth was I just couldn't imagine carrying on working the grueling, fast paced shitshow of a job without my music and the whole pre-work and after work listening routines that it involved. Once I let music go, the gargantuan void that it left in my life just felt irreplaceable. I'm lucky that I can still hear music at all, but just having the awareness that I'm not hearing it as rich and complete as I used to depresses me 10/10. My heart goes out to @FGG big time. I lost sound quality, but she pretty much lost music entirely. Absolute larceny. Those of you that have tinnitus but otherwise normal hearing, be grateful that you still have music as a tool to mask and escape.

Regenerative medicine can't come fast enough! When I get my hearing tuned back up, I'm going to go back to some filthy black and death metal shows but I'm going to do it right with plugs and muffs this time. Don't care wtf I look like. If any metalheads are reading this, FUCK THE TOXIC MASCULINITY, PROTECT YOUR EARS. You DON'T want to end up like Pete Townshend, Brian Johnson, Ted Nudgent... and the list goes on.

 

[DebInAustralia]

I think it would be more worthwhile to try to get the auto-immune disease under control (low-dose prednisone?) as much as possible and once that's accomplished, try to regenerate hearing. Otherwise you'll be fighting a lifelong, uphill battle.

I'd try taking low-dose Naltrexone over Prednisone.

www.ldnresearchtrust.org

Check out the LDN Book by Linda Elsegood.

 

[DebInAustralia]

I am more confident (in fact, very confident) that I have autoimmune-induced hyperacusis/tinnitus than I am that I have AIED in the classical sense. I do not have a diagnosis, and the reason is that I'm borderline for Sjogren's based on objective evidence, but am unable to make it to my appointments to have my lip biopsied. My hyperacusis is very, very severe. Like, with earplugs and earmuffs in, extremely soft noises bother me such as writing, typing, etc. I do not feel ready to get in a car right now.

Anyways, I realize this is a tinnitus forum so I don't really talk about it, but I had very obvious chronic illness in the five years leading up to my hearing problems. I had to take a semester off of grad school where I was extremely sick. Pain everywhere, fatigue, neuropathy, stomach problems, dryness, tons of eye floaters (suddenly). Even when I came back, I felt horrible all of the time. Those five years play a big role in my opinions of this problem. If I was otherwise completely normal and the hyperacusis popped up, I would be more skeptical.

You are right though; it's very strange that I don't have profound hearing loss yet -- especially at the 14 month mark. That's basically unheard of with AIED. I have a couple of theories for this:

1) I don't have AIED. Something else is damaged, but it's not related to hair cells.
2) I do have AIED, but my brain is reactive to the hearing loss, giving me hyperacusis.

I would be amazed if the biopsy was negative, as it would point towards something else. If this isn't autoimmune, I don't know what else it could be.

Even if it is autoimmune, what is driving it? Lyme?

 

[Paulmanlike]

Any thoughts on what the next 2 months will hold? Frequency Therapeutics initially said they were releasing top-line results at the end of September, but that seems like it now may be delayed.

Also, in the Tinnitus Talk Podcast, Carl LeBel mentioned that they were monitoring the patients (but were blinded to who was who) for safety reasons. Do you all think they could be doing that for the Phase 2a study too? I would think there would be a conflict of interest since they hold stock in the company, but maybe those who see the data can't sell or buy shares. And if some of them can see the data, I wonder if Carl LeBel is one of those individuals.

They can't sell or buy stock but take a look at the recent news of Kodak, there were big volume trading increases before the news broke out that they were basically given a huge contract by the US government to make drug components in the fight against COVID-19. The stock shot up 1500% over 2 days.

I always pay attention to insider trading and the financials of a company as it can tell you a lot.

 

[Greg Sacramento]

take a look at the recent news of Kodak

I saw the Kodak news when first released, but didn't buy shares.

What is interesting about major shareholders of Frequency Therapeutics is that one their other top holdings is that of a pet food company which has been doing well. No medical company is listed as another top investment for shareholders of Frequency Therapeutics. I have never seen another medical company where top holders did not have medical, medical research or drug companies listed as top investment. Environmental and social companies are also held by holders of Frequency Therapeutics.

 

[Paulmanlike]

I saw the Kodak news when first released, but didn't buy shares.

What is interesting about major shareholders of Frequency Therapeutics is that one their other top holdings is that of a pet food company which has been doing well. No medical company is listed as another top investment for shareholders of Frequency Therapeutics. I have never seen another medical company where top holders did not have medical, medical research or drug companies listed as top investment. Environmental and social companies are also held by holders of Frequency Therapeutics.

Have you invested yourself Greg?

There are 2 biotechs who I think will have potential to explode although I know there are many out there with potential clinical trials.

FREQ and any of the CRISPR stocks.

But both ridiculously high risk.

 

[Zugzug]

Even if it is autoimmune, what is driving it? Lyme?

I definitely don't have Lyme, as I've tested negative a bunch of times and have treated it with Doxycycline without any changes. I don't subscribe to the belief that autoimmunity is always just hidden viruses. I think the immune system really does get fooled (somehow) into thinking healthy tissue is bad. In some cases, people find a cause for autoimmunity. This is rare. Most stories are people trying everything on earth and not being able to change it. Of course, it's always good to try stuff -- not dissimilar from trying supplements for hyperacusis -- but usually it bares few meaningful results. At best, one finds that something helps the symptoms, but rarely the actual disease process.

 

[sensualmosquito]

Same here, soooo much. I listened to music on the way to work in the truck, at work (just playing it off of my phone with surprisingly good quality), and finally after work I'd smoke up and delve into more music, constantly searching for new bangers and building playlists.

Music fueled me more than any substance, my life revolved around it. And then came the collecting; vinyl, CD, and band shirts. I even have a limited edition black metal album that came with corpsepaint. Fucking kills me to look at it all now. I spent thousands and it's all in duffle bags now.

Immediately after my trauma music sounded tinny and soulless, like someone just sucked all of the bass and soul out of it. My cell phone audio all of a sudden sounded like crap, and only the ear that was on the side of the pocket my phone was in could hear the sound clearly. My low freq hearing was down 25 dB at the time, but has somehow recouped up to 10 dB. Still, nothing sounds as good as it used to before the trauma. And while cannabis used to enhance the listening experience, it now just spikes my tinnitus and draws attention to the uneven hearing.

I left my noisy job 'officially' due to the sound sensitivity and tinnitus, but the truth was I just couldn't imagine carrying on working the grueling, fast paced shitshow of a job without my music and the whole pre-work and after work listening routines that it involved. Once I let music go, the gargantuan void that it left in my life just felt irreplaceable. I'm lucky that I can still hear music at all, but just having the awareness that I'm not hearing it as rich and complete as I used to depresses me 10/10. My heart goes out to @FGG big time. I lost sound quality, but she pretty much lost music entirely. Absolute larceny. Those of you that have tinnitus but otherwise normal hearing, be grateful that you still have music as a tool to mask and escape.

Regenerative medicine can't come fast enough! When I get my hearing tuned back up, I'm going to go back to some filthy black and death metal shows but I'm going to do it right with plugs and muffs this time. Don't care wtf I look like. If any metalheads are reading this, FUCK THE TOXIC MASCULINITY, PROTECT YOUR EARS. You DON'T want to end up like Pete Townshend, Brian Johnson, Ted Nudgent... and the list goes on.

Keep holding on my friend. Hopefully in the next few years there will be something to help you. Its not a question of if, but when. I feel you on the music component of things; it's been the hardest thing for me to let go of out of all the symptoms I have. I took putting on headphones and feeling the music for granted, and I see my brothers jamming and I want to kick myself in the head for letting this happen to me. There will be something for you in time.
If you want to talk, I'm always here.

 

[patorjk]

I saw the Kodak news when first released, but didn't buy shares.

What is interesting about major shareholders of Frequency Therapeutics is that one their other top holdings is that of a pet food company which has been doing well. No medical company is listed as another top investment for shareholders of Frequency Therapeutics. I have never seen another medical company where top holders did not have medical, medical research or drug companies listed as top investment. Environmental and social companies are also held by holders of Frequency Therapeutics.

Astellas made a licensing deal with Frequency Therapeutics that cost them 80 million, so there is interest from the medical community. Where are you getting your information about the top shareholders? From looking online, it looks like they're all investment companies:

https://finance.yahoo.com/quote/FREQ/holders?p=FREQ

 

[FGG]

I definitely don't have Lyme, as I've tested negative a bunch of times and have treated it with Doxycycline without any changes. I don't subscribe to the belief that autoimmunity is always just hidden viruses. I think the immune system really does get fooled (somehow) into thinking healthy tissue is bad. In some cases, people find a cause for autoimmunity. This is rare. Most stories are people trying everything on earth and not being able to change it. Of course, it's always good to try stuff -- not dissimilar from trying supplements for hyperacusis -- but usually it bares few meaningful results. At best, one finds that something helps the symptoms, but rarely the actual disease process.

I think I'm a bit biased on this because one of my former vet school professors is world renown for studying intracellular pathogens. I remember one lecture where he relayed that he had once looked at the hearts of dozens of dogs that died with positive ANAs and with the antemortem diagnosis of autoimmune endocarditis. He was able to culture pathogens that were undetected in the blood in most if not all of them (it's been a long time but if I remember correctly, chiefly E. canis and Bartonella in this case).

I came away believing that true auto immunity is at least somewhat less common than assumed but people don't do an exhaustive search and there is probably a trigger in people that don't have a strong genetic link.

And btw the trigger can be environmental (e.g. Toxins, allergies, etc) it doesn't have to be infectious.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4676776/

 

[tommyd87]

Astellas made a licensing deal with Frequency Therapeutics that cost them 80 million, so there is interest from the medical community. Where are you getting your information about the top shareholders? From looking online, it looks like they're all investment companies:

https://finance.yahoo.com/quote/FREQ/holders?p=FREQ

That's the thing I thought about too. They are all financing entities or similar. See JP Morgan, they are the last ones to buy and I think also Wells Fargo bought.

I think that there wouldn't be much of an interest in it if they thought that there was no benefit.

 

[Greg Sacramento]

From looking online, it looks like they're all investment companies:

I'm talking about shareholders of FREQ that own shares in other companies. Not talking about top institutional holders or mutual funds that own shares in FREQ.

The pet food company is CHEWY (CHWY) mentioned in link below. On some other financial sites, it's also listed close to the top of the top.

Yahoo is not a good site to evaluate financials of any company. You would need to use fee paid hedge sites to get the best financial analysis that provides some input from their medical teams.

For free daily financial information, there's a few good sites. Here is one of them. Notice that FREQ is down today and that because of hedging.

https://www.marketbeat.com/stocks/NASDAQ/FREQ/

I do hope that FREQ will provide success to some, but it will take time before market as the methods that are discussed on medical sites are complicated. Most of what they discuss (non corporate or CEO releases) has not been mentioned or discussed here.

 

[Zugzug]

I came away believing that true auto immunity is at least somewhat less common than assumed

This completely depends on the doctor. For example, I've had holistic doctors tell me that autoimmune diseases are myths -- that the body doesn't ever attack its own tissue, period. At the same rate, standard rheumatologists are usually not open-minded about this stuff, at least not outwardly.

Sadly, I think the "it can be cured" mentality invites a lot of victim blaming -- certainly not from people like you. I just don't think that sick people are close-minded about trying stuff when their lives are horrible. Most people with autoimmune diseases have tried strict diets, lifestyle changes, etc.

Maybe what I should say is that I don't think most autoimmune diseases are caused by known curable viruses. It's possible that there could be microscopic pathogens, but this can't be healed with diet, antivirals, antifungals.

Now if we're talking about the trigger for autoimmune diseases? That is a wide open mystery that I am fully open-minded to. I definitely think pathogens could facilitate the alteration in the immune system.

 

[tommyd87]

Maybe this is wishful thinking, but I wonder if curing/reducing tinnitus is FX-322's ace in the hole. Carl LeBel mentioned that several Phase I/II patients told their ENTs that FX-322 improved their tinnitus. This leaves me with several questions:

* How many of the 15 patients treated with FX-322 had tinnitus?
* How many of these tinnitus suffers experienced a reduction? (all we know is that it was more than 1)
* How big of a reduction did they experience?
* Why did a reduction in tinnitus occur? (if tinnitus is being reduced, it probably means that theory about the brain memorizing the sound is wrong)

Hearing restoration may be the bigger market, but if this drug improves tinnitus then they'll want to go full steam ahead in making sure ENTs know.

I don't know the number, just like you don't obviously. However, I have a feeling, from FREQ being an extremely savvy and well managed firm (in my opinion), that they will inform all stakeholders about its efficacy on tinnitus.

Their ultimate focus and main goal is to assist with hearing restoration, but I think that from a money making situation, stating all possible benefits and reaching out to all customers will enhance their bottom line immensely.

This is critical for FREQ as like any startup company they need to obtain revenue and also turn a profit. The wider their potential customer base is, the better it is for them. And if FX-322 works for other indications other than hearing loss, it can also be accessed off-label.

 

[Toby1972]

Astellas' European clinic trial:

- Any hint when the clinical trial would start?
- Which countries do they take place in?
- How can you enroll in the clinical trial?

I live near Munich, where Astellas has its German headquarters.

I would be the perfect candidate.

I am 44, I have hearing loss in left ear beginning at about 6 kHz, in right ear at about 15 kHz.
I have constant severe, intrusive tinnitus (only the shower masks it), louder in the right ear than in the left.
The tinnitus was mild since 2010, intrusive since 04/2020.
With mental strength and help from various sides I have not gone completely mad (and kept my work for example)

FX-322 is my greatest hope to get back to a normal life.

I would rate the chance all in all (that there will be a clinical trial near me within the next year which I can take part in and that FX-322 helps me) at about 0,01%.

That's infinite times more than 0,00%. Some sarcasm, trying to lol, seems I am not completely mad).

 

[FGG]

Astellas' European clinic trial:

- Any hint when the clinical trial would start?
- Which countries do they take place in?
- How can you enroll in the clinical trial?

I live near Munich, where Astellas has its German headquarters.

I would be the perfect candidate.

I am 44, I have hearing loss in left ear beginning at about 6 kHz, in right ear at about 15 kHz.
I have constant severe, intrusive tinnitus (only the shower masks it), louder in the right ear than in the left.
The tinnitus was mild since 2010, intrusive since 04/2020.
With mental strength and help from various sides I have not gone completely mad (and kept my work for example)

FX-322 is my greatest hope to get back to a normal life.

I would rate the chance all in all (that there will be a clinical trial near me within the next year which I can take part in and that FX-322 helps me) at about 0,01%.

That's infinite times more than 0,00%. Some sarcasm, trying to lol, seems I am not completely mad).

All we know is it will be announced sometime after Phase2A and Astellas is in charge of the specifics.

Clinical trials are not held at company headquarters though but I suppose there could be a testing center nearby (it's possible but not any more or less likely than anywhere else I think).

Have you tried contacting Astellas to ask if they would be willing to release more info?

Btw, since FX-322 is being tested as a hearing drug first, they would likely test your worst (in terms of pure tone average over the most frequencies, not biggest loss at one point) hearing ear, not your worst tinnitus one. But, I personally would still do the trial if I had the chance (even if the hearing loss doesn't bother you as much as the tinnitus) as it would be psychologically soothing to see improvement in one ear while you wait for the drug to come out.

Just my opinion, though.