Frequency Therapeutics — Hearing Loss Regeneration

[tommyd87]

This is why Right To Try isn't enough. We need provisional approval to let drugs actually hit the market earlier as opposed to a process that's riddled with red tape.

I do think this will happen via legislation and the FDA will also improve via reform, but probably not until at least a few years.

By that time FX-322 will already be out. But maybe these changes will help accelerate the release of OTO-413, Hough Pill, and other drugs.

My view is that whatever allowances get made to Right To Try provision, there will still be red tape attached along the way.

For example I expect that they will still need the medicine to go through phase 1 and 2 before they contemplate a release. I am aware certain organisations like Hough said that if their research results are replicated in people then they will then consider a release after they do phase 2.

I cannot see anyway where the change to the law leading to easier access will happen without there being demonstrations that either the drug is safe and has benefit.

 

[Sloth]

By the way, assuming FX-322 doesn't cure tinnitus (which I find unlikely), wouldn't it at least mean that Lenire would be more effective?

I mean on the picture we can see that people without hearing loss benefitted way more than people with hearing loss.

I know Lenire was a disappointment but maybe it would at least be less of a disappointment then.

 

[Cernuto]

How does FX-322 repair cells with only marginal damage? In layman's terms?

 

[Diesel]

I really hope there's an anecdote regarding reactive tinnitus in the Tinnitus Functional Index data when Phase 2a results are announced.

Even if it doesn't help fix reactive tinnitus, I'm still rooting for all of you. I might just be a lost cause.

The TFI is a standardized measurement used to understand how much tinnitus interferes with an individual's ability to function.. Here's a little more about it.. There's a link to the actual test at the bottom of text.

https://www.audiology.org/news/tinnitus-functional-index

What we should expect to see are fairly significant declines in the TFI from the incoming baseline test score. In cases where the tinnitus is high-frequency, we may see scores go to zero or near-zero. This might indicate that people only hear their tinnitus "in a very quiet room." There's still some subjectivity here, but if participants start showing consistent drops in their TFI score, then it's a promising outcome.

Note, in no way should anyone look at FX-322 as a cure for tinnitus. It will not be a "cure."

 

[serendipity1996]

How does FX-322 repair cells with only marginal damage? In layman's terms?

Can't remember where I read it but I think damaged hair cells tend to get cleared away by the body anyway. Please correct me if I am wrong, anyone.

 

[FGG]

My view is that whatever allowances get made to Right To Try provision, there will still be red tape attached along the way.

For example I expect that they will still need the medicine to go through phase 1 and 2 before they contemplate a release. I am aware certain organisations like Hough said that if their research results are replicated in people then they will then consider a release after they do phase 2.

I cannot see anyway where the change to the law leading to easier access will happen without there being demonstrations that either the drug is safe and has benefit.

The law does allow it if the company approves it. You can read Frequency's statement on it on their website.

 

[FGG]

The TFI is a standardized measurement used to understand how much tinnitus interferes with an individual's ability to function.. Here's a little more about it.. There's a link to the actual test at the bottom of text.

https://www.audiology.org/news/tinnitus-functional-index

What we should expect to see are fairly significant declines in the TFI from the incoming baseline test score. In cases where the tinnitus is high-frequency, we may see scores go to zero or near-zero. This might indicate that people only hear their tinnitus "in a very quiet room." There's still some subjectivity here, but if participants start showing consistent drops in their TFI score, then it's a promising outcome.

Note, in no way should anyone look at FX-322 as a cure for tinnitus. It will not be a "cure."

There won't be one cure because it will depend on what is structurally wrong with each individual. This should help a lot of people, though.

 

[AtlasFainted]

My view is that whatever allowances get made to Right To Try provision, there will still be red tape attached along the way.

For example I expect that they will still need the medicine to go through phase 1 and 2 before they contemplate a release. I am aware certain organisations like Hough said that if their research results are replicated in people then they will then consider a release after they do phase 2.

I cannot see anyway where the change to the law leading to easier access will happen without there being demonstrations that either the drug is safe and has benefit.

Are you familiar with what it takes to get a drug after a sponsor allows for expanded access? There's a lengthy paperwork process involved for each individual. For something like FX-322, this means Frequency would have to devote a lot of resources to this "red tape" alone.

If new legislation let drugs hit the market once they are proved relatively safe, this just means it's less work for everyone, and those who are desperate can try promising treatments sooner.

Why should it be the government's job to decide if it's effective anyways? The market can do that just fine, as it does in literally every other industry. That being said, currently the bill we're looking at requires that drugs run through efficacy trials in parallel to provisional market approval.

Really not a much of downside here, at least not one that's worse than the current way of doing things.

 

[Diesel]

Can't remember where I read it but I think damaged hair cells tend to get cleared away by the body anyway. Please correct me if I am wrong, anyone.

Frequency has mentioned that FX-322 will activate regeneration where hair cells are missing or damaged. In this description,I take it to mean there are some damaged hair cells hanging on in some capacity.

 

[AtlasFainted]

Frequency has mentioned that FX-322 will activate regeneration where hair cells are missing or damaged. In this description,I take it to mean there are some damaged hair cells hanging on in some capacity.

This is interesting, I thought damaged cells almost always enter apoptosis.

I'd say maybe they were referring to synapse damage, but that's not what this drug is for...

 

[Lucifer]

If you were injected with FX-322 would it be safe to take NAC and Magnesium? With Hough pill it uses NAC so I was wondering if it's possible to take NAC with FX-322?

Would there be better improvements with the use of NAC alongside with FX-322?

 

[tommyd87]

Are you familiar with what it takes to get a drug after a sponsor allows for expanded access? There's a lengthy paperwork process involved for each individual. For something like FX-322, this means Frequency would have to devote a lot of resources to this "red tape" alone.

If new legislation let drugs hit the market once they are proved relatively safe, this just means it's less work for everyone, and those who are desperate can try promising treatments sooner.

Why should it be the government's job to decide if it's effective anyways? The market can do that just fine, as it does in literally every other industry. That being said, currently the bill we're looking at requires that drugs run through efficacy trials in parallel to provisional market approval.

Really not a much of downside here, at least not one that's worse than the current way of doing things.

I am not American and as a result do not know the intricate workings of that legal/legislative system so I might be wrong. I will have no issues if you tell me I am either.

Essentially though the trouble is the same as in Australia which is my country. Currently the government is responsible from what I have noted for changing the laws relating to the Right To Try ability. As a result the government still wants to protect people from issues in relation to abuse from potentially problematic drugs.

Detail to date strongly shows FX-322 has had no adverse reaction when consumed and also is in no way harmful, however compare that to the types of drugs that can be made and used for issues like drug withdrawal. We (and I assume America is the same) have had issues with these substances being abused and as a result the government will not just release these. There have also been examples where we have seen savvy druggies decide that they can attempt to get access to certain medications for the sole purpose that they contain properties that can be used to manufacture junk.

Therefore there is no other obvious or reasonable method for the regulator or the government to place an exemption for Right To Try to one drug but not to another. As a result the law needs to be uniform for all drugs. Hence while I can see significant merit in making the claim that why should the government get to dictate whether someone tries or not, there needs to be evaluation of the wider implications and effects.

Therefore I feel that this unfortunately will not change in the near future or even throughout time as actually I am pretty positive that the government will not permit people to try medications at their own choice when they are also aware of the possibility they might get exploited.

 

[Tinnitus Talk]

Hey everyone!

After more than a year (no exaggeration) of trying, we finally did it: We interviewed Frequency Therapeutics!

The interview took place last week with Chief Development Officer Carl LeBel. He gave us an hour of his precious time. Not enough to ask all the questions we had in mind, but enough to gain valuable new insights on FX-322.

We were assisted by some wonderful members of the Tinnitus Talk community to pull it off: @FGG helped us prepare the questions and @mrbrightside614 conducted the interview together with @Hazel. The podcast episode is currently being edited by @Autumnly with @Markku assisting. Another volunteer is working on the transcription.

The initial publication will be for Patreon supporters of the Tinnitus Talk Podcast only. Our Patreons can expect us to publish the episode on or (likely) before Friday, July 17th. The general audience will get access about a week later. This is part of our strategy to provide exclusive content to show our gratitude to those who support us financially. Of course, we also hope it will incentivize more people to support us.

We don't get paid for our time (we must have already spent a hundred hours or more on this episode alone), but there are expenses to cover. This episode has cost us over 350 dollars in studio hire and sending a microphone and headphones to Frequency Therapeutics. And that doesn't even cover running costs like subscriptions for recording and editing software. Hence, we kindly ask that if you value our content you too become a Patreon supporter. More interesting interviews will be coming out later this year!

 

[FGG]

If you were injected with FX-322 would it be safe to take NAC and Magnesium? With Hough pill it uses NAC so I was wondering if it's possible to take NAC with FX-322?

Would there be better improvements with the use of NAC alongside with FX-322?

I doubt it would have an effect either way unless you were simultaneously trying to treat inflammation.

 

[AtlasFainted]

I am not American and as a result do not know the intricate workings of that legal/legislative system so I might be wrong. I will have no issues if you tell me I am either.

Essentially though the trouble is the same as in Australia which is my country. Currently the government is responsible from what I have noted for changing the laws relating to the Right To Try ability. As a result the government still wants to protect people from issues in relation to abuse from potentially problematic drugs.

Detail to date strongly shows FX-322 has had no adverse reaction when consumed and also is in no way harmful, however compare that to the types of drugs that can be made and used for issues like drug withdrawal. We (and I assume America is the same) have had issues with these substances being abused and as a result the government will not just release these. There have also been examples where we have seen savvy druggies decide that they can attempt to get access to certain medications for the sole purpose that they contain properties that can be used to manufacture junk.

Therefore there is no other obvious or reasonable method for the regulator or the government to place an exemption for Right To Try to one drug but not to another. As a result the law needs to be uniform for all drugs. Hence while I can see significant merit in making the claim that why should the government get to dictate whether someone tries or not, there needs to be evaluation of the wider implications and effects.

Therefore I feel that this unfortunately will not change in the near future or even throughout time as actually I am pretty positive that the government will not permit people to try medications at their own choice when they are also aware of the possibility they might get exploited.

Yeah, I think you and I have really different values here. As long as a company isn't selling straight up poison and calling it medicine, I don't see what the problem is.

You mention "druggies" exploiting legal drugs for recreational use. So the people these drugs can help shouldn't get to use them because of that?

Personally I believe strongly in individual choice. You can 'exploit' a concrete brick by slamming someone in the head with it. That doesn't mean we should outlaw bricks, does it?

I really think if you took this sort of thinking to the extreme, we would all be locked in padded rooms against our will eating food from plastic trays slid under out doors. That would be "safe" with no risk of harm, but there would be no personal choice, nor personal freedom to take risk.

Who cares what recreational drug users do; it's their bodies. That shouldn't affect the medicine the rest of us have access to.

If something proves relatively safe (like FX-322), release it to the market (tests can continue to be run in parallel), so it can end the suffering of those who are either dying or have their lives on pause due to their condition. They shouldn't have to wait 5 - 10 years for 'permission' to put something in their body.

 

[Born To Slay]

Yeah, I think you and I have really different values here. As long as a company isn't selling straight up poison and calling it medicine, I don't see what the problem is.

You mention "druggies" exploiting legal drugs for recreational use. So the people these drugs can help shouldn't get to use them because of that?

Personally I believe strongly in individual choice. You can 'exploit' a concrete brick by slamming someone in the head with it. That doesn't mean we should outlaw bricks, does it?

I really think if you took this sort of thinking to the extreme, we would all be locked in padded rooms against our will eating food from plastic trays slid under out doors. That would be "safe" with no risk of harm, but there would be no personal choice, nor personal freedom to take risk.

Who cares what recreational drug users do; it's their bodies. That shouldn't affect the medicine the rest of us have access to.

If something proves relatively safe (like FX-322), release it to the market (tests can continue to be run in parallel), so it can end the suffering of those who are either dying or have their lives on pause due to their condition. They shouldn't have to wait 5 - 10 years for 'permission' to put something in their body.

Absolutely agree with everything here. In addition to making society less free, I also want to point out that this ridiculous process is why most companies don't bother with rare disorders, because they're too expensive to put money into. If they just needed to prove a certain level of safety and then just publish the results for medical providers and patients to see, this multimillion dollar obstacle to releasing cures would be eliminated.

 

[tommyd87]

Just to be clear on this. Frequency is not planning to directly manufacture FX-322 with their own facility. They have said so in their 10-K. They retain the rights to distribute/commercialize in the US. They are planning to contract production of the drug with Astellas and/or another 3rd-party "FDA-compliant manufacturer."

The way I read the 10-K, Astellas will probably manufacture the drug, and Frequency will slap their label on it and get the commercial gains within the US. This is an ideal situation; Astellas brings the manufacturing expertise / assets, Frequency gets the cashflow.

The good news for us is the ramp-up time required to stockpile the drug will be short; and Astellas may be able to start manufacturing prior to FDA approval. Astellas also has established distribution to get the drug to providers.

I think it is going to get produced in Japan in the recently developed big factory.

 

[Daniel Lion]

Super excited and nervous for the upcoming Tinnitus Talk Podcast.
I hope Mr. LeBel has good news for us (understatement).

Thanks @Hazel, @Markku, @Autumnly, @mrbrightside614 and @FGG.

We are all grateful to you folks for your hard work and dedication to our cause.

 

[Lucifer]

Super excited and nervous for the upcoming Tinnitus Talk Podcast.
I hope Mr. LeBel has good news for us (understatement).

Thanks @Hazel, @Markku, @Autumnly, @mrbrightside614 and @FGG.

We are all grateful to you folks for your hard work and dedication to our cause.

Now we need Otonomy to be interviewed for the Tinnitus Talk Podcast after they got positive results from their Phase 1 clinical trials for OTO-313. Maybe the interview should wait until after the OTO-413 clinical trial results, though.

 

[Chriscom]

View attachment 39725
Hey everyone!

After more than a year (no exaggeration) of trying, we finally did it: We interviewed Frequency Therapeutics!

The interview took place last week with Chief Development Officer Carl LeBel. He gave us an hour of his precious time. Not enough to ask all the questions we had in mind, but enough to gain valuable new insights on FX-322.

We were assisted by some wonderful members of the Tinnitus Talk community to pull it off: @FGG helped us prepare the questions and @mrbrightside614 conducted the interview together with @Hazel. The podcast episode is currently being edited by @Autumnly with @Markku assisting. Another volunteer is working on the transcription.

The initial publication will be for Patreon supporters of the Tinnitus Talk Podcast only. Our Patreons can expect us to publish the episode on or (likely) before Friday, July 17th. The general audience will get access about a week later. This is part of our strategy to provide exclusive content to show our gratitude to those who support us financially. Of course, we also hope it will incentivize more people to support us.

We don't get paid for our time (we must have already spent a hundred hours or more on this episode alone), but there are expenses to cover. This episode has cost us over 350 dollars in studio hire and sending a microphone and headphones to Frequency Therapeutics. And that doesn't even cover running costs like subscriptions for recording and editing software. Hence, we kindly ask that if you value our content you too become a Patreon supporter. More interesting interviews will be coming out later this year!

View attachment 39726

@Hazel and company, I'm so very grateful that you persisted and saw this through. THANK YOU!

As a Patreon supporter I want to encourage anyone who is able to sign up if you are able--and I'm well aware and respect the fact that many are not in a position to do so. But this resource is incomparable and I literally don't know what I would do without it, or what my mental state would be.

Supporting via Patreon is a great way to keep the wheels turning even when, like me, we're coping with other things (the list is long these days) and can't always be here either.

Or, as my brother once told me, one of the best ways to show love is cold, hard cash

 

[SallyM]

I'm well aware and respect the fact that many are not in a position to do so.

$2/month is the lowest amount to subscribe to? That's really little for the value I get so I just now subscribed for the $5/month.

 

[sssing]

Thanks @Hazel, @Markku, @FGG, @Autumnly, @mrbrightside614 and those who put in their time for this interview. So so thankful for all your persistence and effort

 

[Darren H]

I'm not sure the exact percentages but it was a very potent inducer of regeneration in vitro. It is reasonable to assume delivery is the roadblock if the results are less dramatic clinically. I have a feeling the ultra high frequency results will be extraordinary in the in vivo testing considering how dramatic the word scores changed.

In similar fashion to how these companies have to put their new drugs through years long trials, does anybody know if the same applies for methods of delivery? Does a method of delivery also need to be approved by the legislative bodies?

I have moderate high frequency hearing loss 3000 Hz upwards.

 

[Sloth]

Does a method of delivery also need to be approved by the legislative bodies?

The delivery gel is part of the drug, so yes. They would need to get it approved again. However, since it would be a reformulation this process is way faster (and cheaper).

 

[tommyd87]

In similar fashion to how these companies have to put their new drugs through years long trials, does anybody know if the same applies for methods of delivery? Does a method of delivery also need to be approved by the legislative bodies?

I have moderate high frequency hearing loss 3000 Hz upwards.

It is merely a matter of proving both delivery and treatment are safe. So suffice to say that with no issues it is going to get approved. It will take maybe months.

As there have been no issues in either delivery or medication safety so far, fair chance that there will be no issues with a reformulated drug. So hopefully it will be a mere formality.

 

[serendipity1996]

This is something that kind of intrigues/worries me. We know that hearing loss is associated with cognitive decline and that the sooner hearing loss is treated the better, e.g. people tending to have greater success with hearing aids the earlier they seek treatment as the hearing centers of the brain weaken over time. Would someone with longstanding hearing loss who gets treated with, say, one of the regeneration drugs also require some sort of sound recognition therapy as your brain adjusts to the renewed input?

I could be completely off-base here and and am just going by what I read here: https://www.healthyhearing.com/report/46306-Hearing-loss-auditory-deprivation

 

[FGG]

This is something that kind of intrigues/worries me. We know that hearing loss is associated with cognitive decline and that the sooner hearing loss is treated the better, e.g. people tending to have greater success with hearing aids the earlier they seek treatment as the hearing centers of the brain weaken over time. Would someone with longstanding hearing loss who gets treated with, say, one of the regeneration drugs also require some sort of sound recognition therapy as your brain adjusts to the renewed input?

I could be completely off-base here and and am just going by what I read here: https://www.healthyhearing.com/report/46306-Hearing-loss-auditory-deprivation

Sound therapy, just like in the hearing aid example in the article would be just listening to sound again with more normal input.

 

[sssing]

This is something that kind of intrigues/worries me. We know that hearing loss is associated with cognitive decline and that the sooner hearing loss is treated the better, e.g. people tending to have greater success with hearing aids the earlier they seek treatment as the hearing centers of the brain weaken over time. Would someone with longstanding hearing loss who gets treated with, say, one of the regeneration drugs also require some sort of sound recognition therapy as your brain adjusts to the renewed input?

I could be completely off-base here and and am just going by what I read here: https://www.healthyhearing.com/report/46306-Hearing-loss-auditory-deprivation

Honestly I have never thought about it in this way. It's making me worried. Just hate this hearing problem as one thing compounds on the other and the whole problem gets knottier. My take is could the readjustment part be because the volume is artificially amplified therefore it takes time to adjust to but with regen drugs it's restoring normal function. Just guessing here.

Maybe @FGG or someone else can cue in on this?

 

[sssing]

Sound therapy, just like in the hearing aid example in the article would be just listening to sound again with more normal input.

Sorry but what do you mean? Is it something good?

 

[Diesel]

This is something that kind of intrigues/worries me. We know that hearing loss is associated with cognitive decline and that the sooner hearing loss is treated the better, e.g. people tending to have greater success with hearing aids the earlier they seek treatment as the hearing centers of the brain weaken over time. Would someone with longstanding hearing loss who gets treated with, say, one of the regeneration drugs also require some sort of sound recognition therapy as your brain adjusts to the renewed input?

I could be completely off-base here and and am just going by what I read here: https://www.healthyhearing.com/report/46306-Hearing-loss-auditory-deprivation

I am suspicious of this site and article. It is very commercially motivated.

The problem I have with this and other articles like this on this site is they are using "science" to sell. So, in this case, blurring the lines between being informative and using what they've derived as research data to get you to buy hearing aids. Healthy Hearing partners with Your Hearing Network, a health plan administrator. Which, in turn works with select partner clinics. The end goal for these sites is to bend science with their content to get you to take action: contact a clinic, consider buying hearing aids.

The only people that really knows the answer to your question at this point are Frequency, the patients that have benefitted from FX-322, and their doctors.

Speaking anecdotally, I think the brain and auditory system will start picking up the new sounds from the sensory cells as intended and process as normal. In terms of understanding conversations from improved hearing, I think the results would be pretty immediate.