Frequency Therapeutics — Hearing Loss Regeneration

[FGG]

Apart from the drug or drugs Thanos Tzounopoulos' is investigating are there other drugs designed to address tinnitus and hearing distortion in the pipeline? I'm not aware that any of the drugs for hearing loss would also be pursuing an indication for treating tinnitus. Perhaps you can bring me up to speed on that.

I doubt whether a letter to FDA will do any harm, but when I think back to the AIDS crisis for example, WHO, CDC and FDA, academics, pharma and the medical profession all came together and ultimately the drug approval process was reformed. In general, regulatory processes in the US tend to be reactionary and in the case of AIDS, the world was reacting to a deadly virus.

While tinnitus can be deadly in the sense that it is associated with euthanasia and suicides, it doesn't have the visibility and impact of AIDS.

What I would suggest is that you consider the timing of the letter. Some of us want to push for more NIDCR/NIH funded research thru processes NIDCR will follow as they formulate their 2022 Strategic Plan. We'd love for you to join the group, perhaps your letter could also be directed to other influencers and decision makers apart from NIDCR/NIH. We are scheduled to have a Skype call on the 16th. If you are interested and available, please let @Hazel and @Markku know so that you can be added to the conversation.

Many thanks, TC

Well, per Dr. Liberman cochlear synaptopathy is a strong contender as a cause of tinnitus.

These drugs are in trial for cochlear synaptopathy: PIPE-505 (filed IND, about to start phase 1), Hough pill (between phase 1 and phase 2), OTO-413 (phase 2). Pipeline even has patented PIPE-505 specifically as a tinnitus treatment.

My letter would be specifically addressed to Dr. Woodcock who has written op-eds on FDA reform. She has expressed interest in getting high mortality *and* morbidity drugs to patients faster. She was the sole reason Sarepta got to DMD patients faster. And she didn't need to revamp the whole system to do that. She's the real deal. She gives a shit. She cried with the DMD parents. I just want to make sure she knows how devastating, life altering and even life threatening cochlear damage is.

I don't have Skype but I have used Google Chat's video feature. My hearing is not great for that kind of interaction. I find I have to guess on a lot of words. Do you have an email chain?

 

[Lucifer]

Well, per Dr. Liberman cochlear synaptopathy is a strong contender as a cause of tinnitus.

These drugs are in trial for cochlear synaptopathy: PIPE-505 (filed IND, about to start phase 1), Hough pill (between phase 1 and phase 2), OTO-413 (phase 2). Pipeline even has patented PIPE-505 specifically as a tinnitus treatment.

My letter would be specifically addressed to Dr. Woodcock who has written op-eds on FDA reform. She has expressed interest in getting high mortality *and* morbidity drugs to patients faster. She was the sole reason Sarepta got to DMD patients faster. And she didn't need to revamp the whole system to do that. She's the real deal. She gives a shit. She cried with the DMD parents. I just want to make sure she knows how devastating, life altering and even life threatening cochlear damage is.

I don't have Skype but I have used Google Chat's video feature. My hearing is not great for that kind of interaction. I find I have to guess on a lot of words. Do you have an email chain?

@FGG I appreciate the work you have been doing to try and contact the important people who can help us. It means a lot to me. Thank you.

 

[FGG]

@FGG I appreciate the work you have been doing to try and contact the important people who can help us. It means a lot to me. Thank you.

I'm giving myself a week to finish the letter. I promise to let y'all know what I hear back.

 

[TuxedoCat]

Well, per Dr. Liberman cochlear synaptopathy is a strong contender as a cause of tinnitus.

Hi @FGG,

You sound very heavily invested in synaptopathy as a cause for tinnitus. And, from what you've said, synaptopathy research seems to be fairly advanced . The fact that there are drugs in trial is very, very tangible.

I really hope you can achieve your goal thru Janet Woodcock and don't want to divert you off the path you've laid out.

Thanks and best regards, TC

 

[FGG]

Hi @FGG,

You sound very heavily invested in synaptopathy as a cause for tinnitus. And, from what you've said, synaptopathy research seems to be fairly advanced . The fact that there are drugs in trial is very, very tangible.

I really hope you can achieve your goal thru Janet Woodcock and don't want to divert you off the path you've laid out.

Thanks and best regards, TC

I think there are many different avenues for advocacy. I'm glad you are working on your avenues, too.

Thanks as well. We will beat this one day.

 

[mrbrightside614]

Definitely. The only thing that will different between Phase 2a and Phase 3 is more people.

If results are good for Phase 2a they should release the drug into the market.

I'm praying on this so so so hard.

I'm giving myself a week to finish the letter. I promise to let y'all know what I hear back.

Is there any way to attach co-signers to this letter through some kind of online medium? Would this be amenable @FGG?

@Markku @Hazel

 

[FGG]

Is there any way to attach co-signers to this letter through some kind of online medium? Would this be amenable @FGG?

@Markku @Hazel

I wouldn't mind that at all. Maybe we could share multiple stories and send it all to her?

I planned on telling my story and then talking about the many possible debilitating presentations and incarnations of cochlear damage and what i am advocating for (quicker access) and why I think she would be a great ally for our cause.

I think attaching other stories could only help.

 

[Markku]

Is there any way to attach co-signers to this letter through some kind of online medium? Would this be amenable @FGG?

I wouldn't mind that at all. Maybe we could share multiple stories and send it all to her?

I planned on telling my story and then talking about the many possible debilitating presentations and incarnations of cochlear damage and what i am advocating for (quicker access) and why I think she would be a great ally for our cause.

I think attaching other stories could only help.

Yes, please start a new thread about this in the Awareness & Fundraising category.

Maybe FGG can do that once her letter is ready, to garner feedback from members and brainstorm how to possibly further improve it.

 

[MrCrybaby]

I wouldn't mind that at all. Maybe we could share multiple stories and send it all to her?

I planned on telling my story and then talking about the many possible debilitating presentations and incarnations of cochlear damage and what i am advocating for (quicker access) and why I think she would be a great ally for our cause.

I think attaching other stories could only help.

I don't know if my story is enticing enough, but I'd be willing to contribute!

 

[serendipity1996]

I wouldn't mind that at all. Maybe we could share multiple stories and send it all to her?

I planned on telling my story and then talking about the many possible debilitating presentations and incarnations of cochlear damage and what i am advocating for (quicker access) and why I think she would be a great ally for our cause.

I think attaching other stories could only help.

That sounds great - I am aware that Hyperacusis Research has a section on their site dedicated to patient stories - it's pretty grim reading to be honest but really shows how utterly debilitating and life-ruining these conditions can get - really highlights the need for a quicker road to treatment!

 

[mrbrightside614]

I wouldn't mind that at all. Maybe we could share multiple stories and send it all to her?

I planned on telling my story and then talking about the many possible debilitating presentations and incarnations of cochlear damage and what i am advocating for (quicker access) and why I think she would be a great ally for our cause.

I think attaching other stories could only help.

I think keeping the story succinct but research- and reference dense would make for the most likely scenario that she reads it in its entirety. A plea to humanity and a demonstration of its impact on your quality of life should be enough to pull some heart strings. I think attaching more stories would just weigh it down and deter from its intent to advance research drug availability.

If she gets back to you and opens up a broader dialogue with the tinnitus community, maybe that's the time when others can contribute with their stories.

edit: please tag me when you make the thread in the awareness section! I have some references already cited for a separate function that could bolster your letter.

 

[TuxedoCat]

I think there are many different avenues for advocacy. I'm glad you are working on your avenues, too.

Thanks as well. We will beat this one day.

Well said, FGG.

I'm certainly willing to help you any way I can and will keep an eye out for that opportunity.

I will just go out on a limb here because I don't know if @JohnAdams is still around or in the dog house or what. But, his story is one that demonstrates the extent someone with tinnitus will go to try a treatment. He put himself and his family at some risk trying an unproven treatment. Too bad he never published his story.

 

[Philip83]

https://hearinghealthmatters.org/in...earing-loss-treatment-fx-322-interview-lebel/

Did someone already post this?

 

[FGG]

https://hearinghealthmatters.org/in...earing-loss-treatment-fx-322-interview-lebel/

Did someone already post this?

This seemed like an Audion diss to me:

"This is a unique approach in the field. Some organizations have been attempting to use gene therapy approaches, while others are using single molecules; those programs use an approach called trans-differentiation: essentially making a progenitor cell turn into a hair cell. That's not the way nature intended for it occur."

 

[Lucifer]

This seemed like an Audion diss to me:

"This is a unique approach in the field. Some organizations have been attempting to use gene therapy approaches, while others are using single molecules; those programs use an approach called trans-differentiation: essentially making a progenitor cell turn into a hair cell. That's not the way nature intended for it occur."

Frequency Therapeutics can diss Audion Therapeutics all day if they want to. I bet ya it will be Audion Therapeutics that will release their drug first.

But it will depend on the results for Phase 2 and if Audion Therapeutics will have enough funding for Phase 3 and release of the drug. Frequency Therapeutics already has enough funding to do Phase 2 and 3 trials and probably have enough funding from Astellas to release the drug onto the market

I expect the EU will allow drugs to be released quicker than the US.

 

[FGG]

I must admit that I didn't like that he said "within a decade." I know he was trying to be conservative because it can take up to 12 years to complete a full FDA trial depending on what the FDA wants from a drug company and publicly traded companies always try to be as absolutely conservative in their projections as possible to not get sued later by investors but still.

 

[Lucifer]

I must admit that I didn't like that he said "within a decade." I know he was trying to be conservative because it can take up to 12 years to complete a full FDA trial depending on what the FDA wants from a drug company and publicly traded companies always try to be as absolutely conservative in their projections as possible to not get sued later by investors but still.

I don't think it will be a decade. I reckon 2-3 years but hopefully earlier.

But didn't Frequency Therapeutics had a meeting with the FDA about FX-322 and the FDA stating they consider the drug as a life or death situation?

Surely as soon as Frequency Therapeutics finish their trials, the FDA will approve it, and then the drug is released straight away.

 

[d'Wooluf]

This seemed like an Audion diss to me:

Not for the first time either. Most of the rest of it was read from the Frequency Therapeutics script.

I must admit that I didn't like that he said "within a decade."

As I recall, Dr Chen expressed the hope of a working treatment within 10 years. His lab doesn't even have a candidate treatment as far as I know. So...?

 

[mrbrightside614]

I must admit that I didn't like that he said "within a decade." I know he was trying to be conservative because it can take up to 12 years to complete a full FDA trial depending on what the FDA wants from a drug company and publicly traded companies always try to be as absolutely conservative in their projections as possible to not get sued later by investors but still.

Dagger.jpg

 

[brokensoul]

There we have it.

I knew 2 to 3 years was overly optimistic.

Even 5 years sounded too optimistic to me.

10 years rounded is the more realistic time frame. Hopefully 6 to 7 years if everything goes perfectly.

Definitely a phase 2b after phase 2a.

Let's hope there are some positive results in regards to tinnitus after phase 2a.

They want to get it right, they're not going to rush the release of a new drug that has been tested on a few dozen people, but has a target population of dozens of millions.

 

[FGG]

There we have it.

I knew 2 to 3 years was overly optimistic.

Even 5 years sounded too optimistic to me.

10 years rounded is the more realistic time frame. Hopefully 6 to 7 years if everything goes perfectly.

Definitely a phase 2b after phase 2a.

Let's hope there are some positive results in regards to tinnitus after phase 2a.

They want to get it right, they're not going to rush the release of a new drug that has been tested on a few dozen people, but has a target population of dozens of millions.

I have invested in biotech for a few years and I have a different take on this. My take is the "within ten years" was solely language used to not get sued if there happens to be a delay for any reason. Biotech companies tend to give very conservative timelines.

If you look up biotech lawsuits, this is par for the course. For instance, you can sue a company if they said "within 5 years" and the stock drops based on this "promise" not being delivered because there is some delay for an unforeseen reason.

For that reason, they have to be extremely conservative because class action lawsuits cover any shares that were bought after the announcement. Biotechs have to promise as little as possible between results. Because otherwise it could cost them millions.

Otherwise, I just don't see how they could say "the FDA treats this on par with life of death diseases" in their Q and A and then say "within a decade." I think they are just covering their butts in regards to investor expectations there. In 2 years is still "within a decade" but so is 8 if something unanticipated happens.

 

[FGG]

As I recall, Dr Chen expressed the hope of a working treatment within 10 years. His lab doesn't even have a candidate treatment as far as I know. So...?

Exactly. Chen said "within a decade" and he hasn't even started any IND enabling studies for a specific drug yet. It wouldn't make sense for a drug in phase 2 to have the same time line unless it was stated as a CYA for a publicly traded company and not the actual expected timeline.

 

[d'Wooluf]

Definitely a phase 2b after phase 2a

I don't see any "definitely" in this whole process. They'll adjust their program at the end of each phase depending on results.

 

[Grand05]

They want to get it right, they're not going to rush the release of a new drug that has been tested on a few dozen people, but has a target population of dozens of millions

Like those pharma mobsters really care about it. They are thinking right now how to maximize profits from suffering people.

 

[Lucifer]

I don't see any "definitely" in this whole process. They'll adjust their program at the end of each phase depending on results.

It's a high chance they will move to Phase 3 directly after Phase 2a and a very slim chance of them releasing the drug to the public during Phase 3.

Since the FDA considers this to be a 'life or death' situation, would that mean Frequency Therapeutics might be able to release FX-322 after Phase 2a?

 

[brokensoul]

Like those pharma mobsters really care about it. They are thinking right now how to maximize profits from suffering people.

You can't compare them with multi-billion mega pharma companies where only the bottom line counts. I don't think it applies to them. Not a nice thing to say about people who might save us someday.

 

[brokensoul]

It's a high chance they will move to Phase 3 directly after Phase 2a and a very slim chance of them releasing the drug to the public during Phase 3.

Since the FDA considers this to be a 'life or death' situation, would that mean Frequency Therapeutics might be able to release FX-322 after Phase 2a?

Not life or death, but on the same level as a life altering disease.

 

[FGG]

You can't compare them with multi-billion mega pharma companies where only the bottom line counts. I don't think it applies to them. Not a nice thing to say about people who might save us someday.

View attachment 35510

Agree. Small cap biotechs aren't like "big pharma". They are usually founded by people who dedicated their lives to research.

 

[Joeseph Stope]

Yup, it's a strange one - the general assumption seems to be that hyperacusis sufferers simply can't cope with noises above a certain decibel level but everyone seems to have their own individual triggers which aren't necessarily related to decibel level. For me, I seem to have the biggest issues with laptop/phone speakers when I'm in a spike - I speculate it could be something to do with the frequency or compression but that seems to aggravate my ears the most even at a low volume. It could also be psychological as well.

How strange it is! While I have nothing but sympathy for a fellow-sufferer, I'm relieved that I have a fellow cell-mate out there. I have the same trouble with laptop speakers. I love music but I had to give up on YouTube. But I have two radios -- which were a bit expensive but they both have a much more mellow sound and give me no trouble at all and help distract me from that eternal infernal.

A few months back I got a 2nd hand TV and -- No! there is nothing psychological about it, it drives my tinnitus sky-high. And it wasn't just watching the programmes, I spent two or three days playing DVDs and CDs and each time it drove my tinnitus sky-high.

 

[andreimatei]

This may be a very dumb question, but is there any correlation between their stock price (which is doing very well) and how hopeful we should be?

I'm guessing everyone's answer will be "no" but thought it might be a good discussion point.