Frequency Therapeutics — Hearing Loss Regeneration

[tommyd87]

I think psychedelics are looking really promising for potentially treating certain mental health conditions but I'm not sure if they would help with tinnitus. From my own experience with them there was no effect on my tinnitus whatsoever. I think the regenerative drugs would help our systems revert back to normal and undo the maladaptive plasticity that has occurred. But it's still something interesting to ponder.

I tend to totally agree. At this stage I certainly am of the view that the treatments that deal with the underlying conditions will work with restoring what has broken. I have to say I think that it is incredibly unlikely that psychedelic medicines will do anything for tinnitus. This is a bit of a wild guess.

 

[WickedCarnival]

If Phase 1/2 patients already reported improvements in their tinnitus from a single dose of FX-322 alone, why would adding psychedelics provide any additional benefit?

Seems to me that the regenerated hair cells were enough to begin reversing the brain's perception of tinnitus without all the "add-ons."

Speaking anecdotally: If I woke up one morning shortly after receiving FX-322, and noticed my tinnitus continued to be quieter than usual, I would certainly feel pretty good about it and would naturally expect to begin reversing the depression/anxieties associated with the conditions.

I'm not sure others here agree?

I can see your point, in my hypothesis, the psychedelic therapy would speed up the re-conditioning and recovery of depression and anxiety, which are highly correlated to tinnitus. As commonly known, some people without hearing loss (even when tested in the high frequencies) still have tinnitus, so that may be affected by somewhere in the brain (DMN, brainstem, auditory cortex, whatever affects hearing, attention, and mood). I can attest that I suffer from anxiety and depression since late childhood, and I did not have noticable tinnitus back then. It wasn't until my early twenties when I graduated college and got into the world of work and careers (which I hate) that amplified anxiety and depression, and that was when I started learning and reading about tinnitus because it started to become intrusive. I was able to hear up to 18kHz up until mid twenties, and at age 30 now I can still hear up to 16-17kHz (and still have bothersome tinnitus).

Paul Stamets has something to say about lion's mane mushrooms and psilocybin mushrooms affecting "neurogenesis" and repairing auditory neurons. Although no additional larger scale research studies have been conducted, I think it's worth looking into: https://medium.com/psychedelic-fict...-mane-protocol-good-news-it-works-3cfd6d9f08b

He's been doing a lot of great work in his field and I do not associate him with pseudoscience or snake oil at all. He's just ahead of a few scientific communities lagging in research at the moment. Here's some preliminary research (see section 4.6): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5987239/

 

[Joly]

When will the clinical trials in Europe start?

 

[tommyd87]

When will the clinical trials in Europe start?

Probably after the US trials. The phase 2b/3 is a direct outcome of whether the current trial is successful or not because they are the next step in the trial process.

 

[frpp]

It looks like we will have to wait several years before FX-322 is available. I guess Billy and Diesel are right. Barring huge news in 2021, it probably won't be released early. Let the depression continue.

I know it's rough suffering week after week but, stay positive, in just a few years our ears and lives will be back to normal. We're going to be the 1st generation of sufferers to beat this affliction. With all the positive actions being taken by Frequency Therapeutics these past few months, I think the results coming in May are going to be a blowout and exceed all of our expectations.

 

[tbuzz89]

I think the results coming in May are going to be a blowout and exceed all of our expectations.

I like your positivity and really, really hope you're right.

 

[Street Novelist]

I know it's rough suffering week after week but, stay positive, in just a few years our ears and lives will be back to normal. We're going to be the 1st generation of sufferers to beat this affliction. With all the positive actions being taken by Frequency Therapeutics these past few months, I think the results coming in May are going to be a blowout and exceed all of our expectations.

You make it sound like a few years is no big thing. We've already been waiting several years. To think it might take 2-3 more years. I wonder, truly, how many people can just stomach that. Also, life is short. Any one of us could be dead in 2-3 years. New governments could change regulations, making it harder to get FDA approval. You just don't know.

 

[TrevorSanders]

You make it sound like a few years is no big thing. We've already been waiting several years. To think it might take 2-3 more years. I wonder, truly, how many people can just stomach that. Also, life is short. Any one of us could be dead in 2-3 years. New governments could change regulations, making it harder to get FDA approval. You just don't know.

2-3 years is nothing.

Be grateful that we live in a time that the possibility of a cure is even being discussed.

 

[weab00]

You make it sound like a few years is no big thing. We've already been waiting several years. To think it might take 2-3 more years. I wonder, truly, how many people can just stomach that. Also, life is short. Any one of us could be dead in 2-3 years. New governments could change regulations, making it harder to get FDA approval. You just don't know.

What other choice do we have? The world is unfair.

 

[Michael01]

I have some semi-good news. I contacted MyTomorrows regarding Compassionate Use of FX-322 and from the sound of the message I got, it sounds like it might be possible to get an EAP release to FX-322, or at least talk to them about such a thing.

I'll keep you posted about any developments on that front. I've posted a screenshot of the message.

 

[L34]

Do any of you think it is possible that regular GPs could be allowed to do the injection, or is it only ENTs? I know we only mention ENTs in this thread, but if GPs wanted to, would they be able to?

 

[Philip83]

You make it sound like a few years is no big thing. We've already been waiting several years. To think it might take 2-3 more years. I wonder, truly, how many people can just stomach that. Also, life is short. Any one of us could be dead in 2-3 years. New governments could change regulations, making it harder to get FDA approval. You just don't know.

I'd consider it pretty pessimistic to worry about regulatory changes at the FDA at this point. Is anything pointing towards this? Frequency Therapeutics is already in conversation with them and have been approved a Fast Track status as well.

Of course any amount of time is too long to wait for this to be available and work. But if you put 2-3 years (if it comes to that) into perspective of a human lifetime (80 years) it's 3% of your life you have to wait. It's not too bad.

 

[Fields]

I know it's rough suffering week after week but, stay positive, in just a few years our ears and lives will be back to normal. We're going to be the 1st generation of sufferers to beat this affliction. With all the positive actions being taken by Frequency Therapeutics these past few months, I think the results coming in May are going to be a blowout and exceed all of our expectations.

This is what helps me to stay positive. My grandmother has been suffering from tinnitus since the 60s without any outlook on a cure—and probably won't live to see FX-322 released to market.

Tinnitus is truly a terrible affliction, and frequently has me struggling, but at least I can look forward towards some form of alleviation in the (near) future.

 

[Lucifer]

Do any of you think it is possible that regular GPs could be allowed to do the injection, or is it only ENTs? I know we only mention ENTs in this thread, but if GPs wanted to, would they be able to?

No, definitely not. It has to be an ENT as they have all the equipment and experience to do the injections. If it was a pill then a normal GP could prescribe it.

 

[GBB]

Many of the psychedelic drugs being decriminalized such as psilocybin, ayahuasca, and MDMA have been showing potential to relieve tinnitus by rapidly re-wiring parts of the brain that respond to anxiety and threat detection that causes the tinnitus feedback loop. Not only that, but effective for helping treatment-resistant depression and anxiety. I bet many people here qualify for the diagnosis of treatment-resistant depression/anxiety regardless of whether they have tinnitus. But that's just my hunch.

I predict a "tinnitus destroying" treatment combo would be be FX-322/Hough Ear Institute Pill + psychedelic psychotherapy / CBT that will address both the biological damage, and psychological pathways. That would be a highly effective strategy as psychedelic therapy is usually no more than 4-6 sessions, and doesn't require regular dosages of the drug (unless a patient is experimenting with microdosing).

This would be as close to a "cure" as you can get. The upfront cost and investment would be high to a patient, but in the long run would save so much money by eliminating hearing aids, noise/TRT devices, snake oil scams, chronic use of medications such as SSRIs (which many side effects include tinnitus, diminished creativity, sexual dysfunction), and useless ENT appointments. And to boot, proper psychedelic treatment can enhance patients' capacities for creativity and improve sexual relationships. All good things!

Injecting psychedelics into the process is like trying to pick a lock with a shotgun - there's no reason to think it's needed at this time.

Do any of you think it is possible that regular GPs could be allowed to do the injection, or is it only ENTs? I know we only mention ENTs in this thread, but if GPs wanted to, would they be able to?

I doubt a GP, likely unfamiliar with an intratympanic injection, would want to do this.

More importantly, why would you want someone less familiar with the process sticking needles in your ear?

 

[L34]

No, definitely not. It has to be an ENT as they have all the equipment and experience to do the injections. If it was a pill then a normal GP could prescribe it.

Okay, thought so too, but had to ask

I doubt a GP, likely unfamiliar with an intratympanic injection, would want to do this.

More importantly, why would you want someone less familiar with the

Okay, it was a long shot, but worth asking. I just thought, that when/if this comes to market, there will be months, perhaps years of waiting to even get an appointment with an ENT. Depending on the demand off course...

 

[GBB]

How about we get some actual data before everyone starts assuming this will be a cure?

 

[tbuzz89]

How about we get some actual data before everyone starts assuming this will be a cure?

Agreed. I'm guilty of perpetuating some of the hopeful and speculative conversation on this thread, but I do think we need to be cautiously optimistic as we don't have any true trial data as it relates to FX-322's efficacy on tinnitus yet. Indeed, FX-322 does have data that, on the surface, is more promising than other potential treatments in the past, but preparing for bad news is always a good idea mentally.

 

[GBB]

Agreed. I'm guilty of perpetuating some of the hopeful and speculative conversation on this thread, but I do think we need to be cautiously optimistic as we don't have any true trial data as it relates to FX-322's efficacy on tinnitus yet. Indeed, FX-322 does have data that, on the surface, is more promising than other potential treatments in the past, but preparing for bad news is always a good idea mentally.

I'm buoyed by the fact that they reported anecdotal success early on for tinnitus, but without data, just want to temper my expectations.

 

[swc5150]

Just to add a positive thought... Perhaps FX-322 will help/cure tinnitus even if it's not a savior for hearing loss, being that audiograms don't need to be bad when someone has tinnitus. The hidden / unknown hearing loss aspect. Maybe FX-322 will knock that out regardless? Positive vibes to all

 

[Philip83]

A newly posted summary of where they're at:

Frequency Therapeutics Provides Business Updates and Reports Third Quarter 2020 Financial Results

I like:

"The results of the Phase 2a end of study analysis, as well as anticipated results from the age-related hearing loss and severe SNHL studies, are expected to provide the basis for an end of Phase 2 meeting with the US Food and Drug Administration regarding potential pivotal studies of FX-322."​

They're not sitting around rolling their thumbs at least!

 

[Pitseleh]

How about we get some actual data before everyone starts assuming this will be a cure?

This.

It brings a pretty strange sensation to read all these posts full of assumptions. It's like everyone on this thread has become a specialist ^^

I like the positivity though!

But I guess that's just a human thing to hold on to whatever hope there may be, even when nothing actually proves FX-322 will be the long-awaited savior.

 

[Lucifer]

This.

It brings a pretty strange sensation to read all these posts full of assumptions. It's like everyone on this thread has become a specialist ^^

I like the positivity though!

But I guess that's just a human thing to hold on to whatever hope there may be, even when nothing actually proves FX-322 will be the long-awaited savior.

I guess so but those patients that received a dose of FX-322 in the Phase 1B clinical trial, 4/15 experienced significant improvements. No drug has ever done that before and the likelihood of them faking their results is low. This is why we have so much faith in FX-322.

 

[tommyd87]

I guess so but those patients that received a dose of FX-322 in the Phase 1B clinical trial, 4/15 experienced significant improvements. No drug has ever done that before and the likelihood of them faking their results is low. This is why we have so much faith in FX-322.

Not to mention the data that showed they achieved full regrowth in lab work which was done as well. Both the trial results and these lab results, as well as the other work done around the medicine development are reasons to be optimistic about FX-322's future progression.

 

[tommyd87]

Just to add a positive thought... Perhaps FX-322 will help/cure tinnitus even if it's not a savior for hearing loss, being that audiograms don't need to be bad when someone has tinnitus. The hidden / unknown hearing loss aspect. Maybe FX-322 will knock that out regardless? Positive vibes to all

I think FX-322 has shown to regrow synapses and hair cells which are both missing and this then tends to be the likely source of what is benefitting tinnitus.

 

[tommyd87]

You make it sound like a few years is no big thing. We've already been waiting several years. To think it might take 2-3 more years. I wonder, truly, how many people can just stomach that. Also, life is short. Any one of us could be dead in 2-3 years. New governments could change regulations, making it harder to get FDA approval. You just don't know.

I'd consider it pretty pessimistic to worry about regulatory changes at the FDA at this point. Is anything pointing towards this? Frequency Therapeutics is already in conversation with them and have been approved a Fast Track status as well.

Of course any amount of time is too long to wait for this to be available and work. But if you put 2-3 years (if it comes to that) into perspective of a human lifetime (80 years) it's 3% of your life you have to wait. It's not too bad.

I think the comment made by @Philip83 is accurate. A lot of the stuff we have seen from government and also a number of others involved in this field like the representatives in the US government have actually been making major moves to ensure that the FDA is able to and will approve medicines much more rapidly and more favourably than they have before.

This has been seen multiple times recently with things like the FDA actually being encouraged to fast track treatments and medicines ASAP where able to and also actually encourage things like expanded access to happen. Then there tends to be the new laws in the works like provisional access allowing new medicines to be given approval for use while they complete their phase 3 trial when they tend to show promise that they are actually very likely to pass the FDA trials. This tends to benefit pharmaceutical companies and consumers because it is likely that the medicine will be available sooner and that then the firms have a lot more certainty around it being of value to invest in things like distribution and also manufacturing amongst other things to get the medicines out quicker. Although we don't have this law in place yet, the Frequency Therapeutics situation is exactly what would benefit from such law. Looking at it, I don't think that there would be any debate or conjecture about whether FX-322 would or would not be released through compassionate access if the provisional approval law was in place because there would be no burdens or additional costs incurred by Frequency Therapeutics if they needed to undertake a short run of medicine manufacturing.

This tends to indicate more so that the FDA will have less red tape tied to its decision making meaning more access to treatments totally sooner. Systems like these are also actually supported by both sides of politics in America and as a result it is incredibly unlikely we will see the new government even be willing to change things. In fact I think that we will see both parties agree and do all they can to make the FDA less regulated as well in the future.

2-3 years is nothing.

Be grateful that we live in a time that the possibility of a cure is even being discussed.

i think this tends to be true. These treatments turn out to be successful in their current trials, then we are merely a few years away actually from getting a solution. Something says it could even be sooner than that too.

 

[weab00]

Now I'm wondering if FX-322 will do anything to help noxacusis after reading that study with the mice cochlea. Hyperacusis sufferers will probably need it regardless since most of us have tinnitus and distortions.

 

[vttbx]

I can see your point, in my hypothesis, the psychedelic therapy would speed up the re-conditioning and recovery of depression and anxiety, which are highly correlated to tinnitus. As commonly known, some people without hearing loss (even when tested in the high frequencies) still have tinnitus, so that may be affected by somewhere in the brain (DMN, brainstem, auditory cortex, whatever affects hearing, attention, and mood). I can attest that I suffer from anxiety and depression since late childhood, and I did not have noticable tinnitus back then. It wasn't until my early twenties when I graduated college and got into the world of work and careers (which I hate) that amplified anxiety and depression, and that was when I started learning and reading about tinnitus because it started to become intrusive. I was able to hear up to 18kHz up until mid twenties, and at age 30 now I can still hear up to 16-17kHz (and still have bothersome tinnitus).

Paul Stamets has something to say about lion's mane mushrooms and psilocybin mushrooms affecting "neurogenesis" and repairing auditory neurons. Although no additional larger scale research studies have been conducted, I think it's worth looking into: https://medium.com/psychedelic-fict...-mane-protocol-good-news-it-works-3cfd6d9f08b

He's been doing a lot of great work in his field and I do not associate him with pseudoscience or snake oil at all. He's just ahead of a few scientific communities lagging in research at the moment. Here's some preliminary research (see section 4.6): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5987239/

I plan on starting the Stamets NPLS stack in the next few weeks if my source is legit. I may have missed it, but I have yet to see anyone on this forum mention that they tried it. There are prior users of Psilocybin, Lion's Mane, and Niacin, but no one has tried the stack. I'm already a big fan of Lion's Mane. Niacin has given me bad spikes before, but it usually happens after prolonged use. It will be the first time for me taking Psilocybin, so it will be a micro-dose for sure. I have zero interest in using it for recreational purposes.

 

[Philip83]

This.

It brings a pretty strange sensation to read all these posts full of assumptions. It's like everyone on this thread has become a specialist ^^

I like the positivity though!

But I guess that's just a human thing to hold on to whatever hope there may be, even when nothing actually proves FX-322 will be the long-awaited savior.

Well, basically completely restoring an inner ear function, be it in a lab, is more than "hope to hold on to", it's a fact.

And I personally would be satisfied with a 25% alleviation, not necessarily a cure.

 

[Pitseleh]

Well, basically completely restoring an inner ear function, be it in a lab, is more than "hope to hold on to", it's a fact.

And I personally would be satisfied with a 25% alleviation, not necessarily a cure.

I'm not talking about inner ear function. I've followed the evolution of the company, I know what they can do with hearing.

I'm talking about tinnitus itself and it's pretty clear now that tinnitus is not only a matter of hearing. A lot is happening in the brain, if not most of it, no matter the source of the problem.

It is not proven that restoring hearing will suppress tinnitus. We are only making speculations.

The available data isn't pointing to suppression of tinnitus. It shows that it helped some people's tinnitus.

OK, that's good, but other medications do that already, and again, they are psych meds.

There is not yet any formal diagnosis for tinnitus. Until we don't know precisely why tinnitus arises and stays for some people while it remains temporary for others, we won't have a cure for everybody.

But I'll admit it's a great step to treat hearing loss. Hearing better is always good when it comes to tinnitus anyway.

And guys, that's fine, be happy, be faithful, that's cool

I'm just worried you'll face big disappointments when the treatment is out.

Again, I'm an optimistic as well, I'm just waiting for actual proof. We're in the clinical study still.