Frequency Therapeutics — Hearing Loss Regeneration

[Orions Pain]

It would be awesome if they proceeded to Phase 3 with promising results for tinnitus and expanded trial enrollment for those who have minor/super high frequency/hidden hearing loss to be able to participate.

For those who have severe tinnitus, it could be worth the risk.

 

[Princebeyel]

Thank goodness then for OTO-6XX that is also on the horizon.

They are still in pre-clinical, no?

I, like the others, am betting for FX-322 to fix my hearing loss/tinnitus.

 

[Koz]

I, like the others, am betting for FX-322 to fix my hearing loss/tinnitus.

Yeah so am I once FX-322 shows efficacy for severe hearing loss. And if not, then OTO-6XX is targeted specifically for the severe hearing loss group. It's either one or the other unless something else pops up that is a bit more encouraging and clearer than Hough Ear Institute or a faster than PIPE-505.

I just realised you probably misunderstood what I meant by "on the horizon" - I meant as a potential existent option to come down the line for myself and people like me with severe hearing loss.

 

[tbuzz89]

For those who have severe tinnitus, it could be worth the risk.

I'd take the risk as it stands right now and get multiple injections of FX-322 in both ears today if I could.

As someone with super high frequency tinnitus, the drug is worth its weight in gold considering it repairs the higher frequencies first.

 

[Lucifer]

It would be awesome if they proceeded to Phase 3 with promising results for tinnitus and expanded trial enrollment for those who have minor/super high frequency/hidden hearing loss to be able to participate.

For those who have severe tinnitus, it could be worth the risk.

There could be a possibility of them skipping the pivotal phase for FX-322 if they can get Breakthrough Therapy designation and positive results in the multiple trials they are doing this year.

 

[d'Wooluf]

Slightly off-topic but some people here have been bashing the FDA for years. This might make those people smile. Personally I prefer my regulatory authorities to make science-based decisions.

"FDA was blindsided Monday when HHS Secretary Alex Azar approved rules designed to reduce scrutiny of drugs and medical devices before they reach market, four senior FDA officials and a person familiar with discussions said."

FDA fights for independence in Trump administration's final days

 

[Street Novelist]

There could be a possibility of them skipping the pivotal phase for FX-322 if they can get Breakthrough Therapy designation and positive results in the multiple trials they are doing this year.

One can only hope... but I'm pessimistic.

 

[Lucifer]

One can only hope... but I'm pessimistic.

Same man. I've been trying to be positive but it can be so draining.

 

[Orions Pain]

There could be a possibility of them skipping the pivotal phase for FX-322 if they can get Breakthrough Therapy designation and positive results in the multiple trials they are doing this year.

That would be amazing. I am so looking forward to this 90 day readout.

 

[Drachen]

I, like the others, am betting for FX-322 to fix my hearing loss/tinnitus.

Yeah so am I once FX-322 shows efficacy for severe hearing loss. And if not, then OTO-6XX is targeted specifically for the severe hearing loss group.

Don't forget about OTO-413, since addressing possible synaptopathy is a potential solution as well. There's no clear timeline for that drug, but if everything goes smoothly, it should(*) release within a year or two of FX-322.

 

[tommyd87]

Slightly off-topic but some people here have been bashing the FDA for years. This might make those people smile. Personally I prefer my regulatory authorities to make science-based decisions.

"FDA was blindsided Monday when HHS Secretary Alex Azar approved rules designed to reduce scrutiny of drugs and medical devices before they reach market, four senior FDA officials and a person familiar with discussions said."

FDA fights for independence in Trump administration's final days

This is positive and it is I think good that this is coming from the Republicans and not the Democrats. I definitely think that there are members of both sides who believe that the techniques and methods utilised by the FDA are somewhat excessive and cumbersome, hence the interest in implementing things like the Promising Pathways Act.

The thing is though that it is not necessarily a matter of treatment and medicine being rejected or approved on the basis of scientific decisions but rather the ridiculous rationale that the FDA utilises in their decision making, which does not seem plausible or is illogical. It is legislation like the Promising Pathways Act which will implement a lot of common sense into the decision making processes of the FDA.

There could be a possibility of them skipping the pivotal phase for FX-322 if they can get Breakthrough Therapy designation and positive results in the multiple trials they are doing this year.

This is an interesting theory. There is every possibility that Frequency Therapeutics has been talking about the pivotal trial because it is the normal course and also actually the likely path that FX-322 will need to take before it can gain approval to be released. This is consistent with Frequency Therapeutics' technique of not making unfounded claims about FX-322. I think that there is no way Frequency Therapeutics will say anything about possibly going straight to market post Phase 2 until they can do so, which probably won't be until such approval is granted.

 

[ajc]

@Princebeyel, your mom called Frequency Therapeutics regarding Compassionate Use? Can you tell more of what they said and what happened?

 

[Princebeyel]

@Princebeyel, your mom called Frequency Therapeutics regarding Compassionate Use? Can you tell more of what they said and what happened?

They said to wait until after my appointment on the 21st to give it three weeks and to call back. That it was a possibility they would offer it. I feel if more people would call and ask for it they may offer it.

 

[Gorbeh3]

They said to wait until after my appointment on the 21st to give it three weeks and to call back. That it was a possibility they would offer it. I feel if more people would call and ask for it they may offer it.

Is there a serious opportunity for compassionate use? Would you have to make an appointment at their HQ in Massachusetts? Did you just call the number on their website?

 

[NewLionel]

Is there a serious opportunity for compassionate use? Would you have to make an appointment at their HQ in Massachusetts? Did you just call the number on their website?

Mmm... yeah, isn't this huge news?

 

[Diesel]

Is there a serious opportunity for compassionate use? Would you have to make an appointment at their HQ in Massachusetts? Did you just call the number on their website?

The process varies, but typically it requires that you and your doctor submit a request form for compassionate use. Then it's usually a back and fourth with the doctor and Frequency Therapeutics or it's contract manufacturer to arrange delivery, instructions for care, assessment, etc.

 

[Princebeyel]

Is there a serious opportunity for compassionate use? Would you have to make an appointment at their HQ in Massachusetts? Did you just call the number on their website?

She did call the number on the website, yes, and the way it sounded, yes, there is an opportunity. I'm very hopeful.

 

[Pete88]

She did call the number on the website, yes, and the way it sounded, yes, there is an opportunity. I'm very hopeful.

I hope you are able to get this done! Your story and situation sounds horrible. I'm confident that this drug can at least make a significant increase in people's daily lives.

 

[Princebeyel]

We just called the number on their website and got the run around. They told us that a doctor would have to contact them.

Can you share how you contracted them to get the better response?

My mom actually talked to them by calling the main number. I believe in order to obtain compassionate use your doctor would need to contact them.

 

[Lucifer]

She did call the number on the website, yes, and the way it sounded, yes, there is an opportunity. I'm very hopeful.

Good luck and I hope they let you get FX-322 shots.

 

[Paulmanlike]

Mr. Langer is talking on the 21st January... I think it's just another investor conference. What's interesting is that Frequency Therapeutics has had some big purchasing of shares, driving the price to over double of its IPO. People have confidence in this company.

My tinnitus feels like it's getting worse... but it varies. Some days it's manageable and some days it's intrusive.

NOT LONG TO GO FOLKS FOR WHAT WE HAVE ALL BEEN WAITING FOR.

 

[Diesel]

Mr. Langer is talking on the 21st January... I think it's just another investor conference. What's interesting is that Frequency Therapeutics has had some big purchasing of shares, driving the price to over double of its IPO. People have confidence in this company.

My tinnitus feels like it's getting worse... but it varies. Some days it's manageable and some days it's intrusive.

NOT LONG TO GO FOLKS FOR WHAT WE HAVE ALL BEEN WAITING FOR.

Langer's presentation is on January 19th, 2021.

I would encourage all here to listen in, should be interesting...

The Potential for Restorative Treatments for Acquired Sensorineural Hearing Loss

 

[serendipity1996]

Mr. Langer is talking on the 21st January... I think it's just another investor conference. What's interesting is that Frequency Therapeutics has had some big purchasing of shares, driving the price to over double of its IPO. People have confidence in this company.

My tinnitus feels like it's getting worse... but it varies. Some days it's manageable and some days it's intrusive.

NOT LONG TO GO FOLKS FOR WHAT WE HAVE ALL BEEN WAITING FOR.

Is the event not on the 19th January? Or is that a different one? It's nice that there will be 4 speakers including Mr. Langer so will be interesting to get some different perspectives.

Frequency Therapeutics to Host Investor Event on the Potential for Restorative Treatments for Acquired Sensorineural Hearing Loss

 

[Diesel]

This is positive and it is I think good that this is coming from the Republicans and not the Democrats. I definitely think that there are members of both sides who believe that the techniques and methods utilised by the FDA are somewhat excessive and cumbersome, hence the interest in implementing things like the Promising Pathways Act.

The thing is though that it is not necessarily a matter of treatment and medicine being rejected or approved on the basis of scientific decisions but rather the ridiculous rationale that the FDA utilises in their decision making, which does not seem plausible or is illogical. It is legislation like the Promising Pathways Act which will implement a lot of common sense into the decision making processes of the FDA.

This is an interesting theory. There is every possibility that Frequency Therapeutics has been talking about the pivotal trial because it is the normal course and also actually the likely path that FX-322 will need to take before it can gain approval to be released. This is consistent with Frequency Therapeutics' technique of not making unfounded claims about FX-322. I think that there is no way Frequency Therapeutics will say anything about possibly going straight to market post Phase 2 until they can do so, which probably won't be until such approval is granted.

Not to get political on you, but it was the Obama/Biden administration that brought the last significant "renovation" to the FDA that brought incentives like the Breakthrough Therapy Status. As VP, Biden was a proponent of accelerating programs for treating cancer and other terminal diseases. Promising Pathways Act may see some acceleration under Biden, but probably not soon enough to affect the progress of FX-322.

However, I did notice today that Biden elevated the Science Office to a Cabinet Level position. This may lead to other legislation that promotes the FDA using more common-sense, good-science based decision-making. It may also just be virtue signaling that the Administration will be taking science seriously for a change.

Biden will elevate White House science office to Cabinet-level

 

[tbuzz89]

All of the announcements, events, purchase movement of shares, etc. really shows some signs that Frequency Therapeutics knows they have something. I see all of this as excellent news and really makes me think that FX-322 might be better than what we already hope it to be.

 

[Aaron91]

NOT LONG TO GO FOLKS FOR WHAT WE HAVE ALL BEEN WAITING FOR.

I am frothing at the mouth for this stuff.

 

[DavidTyl]

Does anybody know (or have some idea) how effective FX-322 may be for those with tinnitus like me; who have no real hearing loss or difficulty in hearing.

In fact I have been told by two audiologists my hearing is superb and very sensitive. My hearing test came out with both ears around the 5 dB from 250 Hz - 1 kHz, then with both ears near to 0 dB from 4 kHz to 8 kHz. My hearing test dips around the 2 kHz - 4 kHz mark in mainly the left ear (lowest to 10 dB). My buzz like tinnitus and sensitive ear is really all coming from the left ear. I have near perfect hearing tests up to 8 kHz. I think my tinnitus has come from damage to the higher frequencies.

Do we know if people like me are in the clinical trials and if FX-322 will help with those higher frequencies? Or have they just picked people with really poor hearing?

 

[Diesel]

Does anybody know (or have some idea) how effective FX-322 may be for those with tinnitus like me; who have no real hearing loss or difficulty in hearing.

In fact I have been told by two audiologists my hearing is superb and very sensitive. My hearing test came out with both ears around the 5 dB from 250 Hz - 1 kHz, then with both ears near to 0 dB from 4 kHz to 8 kHz. My hearing test dips around the 2 kHz - 4 kHz mark in mainly the left ear (lowest to 10 dB). My buzz like tinnitus and sensitive ear is really all coming from the left ear. I have near perfect hearing tests up to 8 kHz. I think my tinnitus has come from damage to the higher frequencies.

Do we know if people like me are in the clinical trials and if FX-322 will help with those higher frequencies? Or have they just picked people with really poor hearing?

Chances are you do have hearing loss. Either at frequencies not specifically tested on the normal audiogram (i.e. 5 kHz, 6.5 kHz, 7 kHz) or in the extended range (8 kHz +). If you can't hear a sound in a range that humans should (approx 20 Hz - 20 kHz), it's still hearing loss from a biological standpoint.

Frequency Therapeutics suspects that FX-322 is restoring hearing at the highest frequencies first, and may be treating tinnitus. We'll know more in Q1 and Q2 when they release results of the active Phase 2A.

 

[Aaron91]

Does anybody know (or have some idea) how effective FX-322 may be for those with tinnitus like me; who have no real hearing loss or difficulty in hearing.

In fact I have been told by two audiologists my hearing is superb and very sensitive. My hearing test came out with both ears around the 5 dB from 250 Hz - 1 kHz, then with both ears near to 0 dB from 4 kHz to 8 kHz. My hearing test dips around the 2 kHz - 4 kHz mark in mainly the left ear (lowest to 10 dB). My buzz like tinnitus and sensitive ear is really all coming from the left ear. I have near perfect hearing tests up to 8 kHz. I think my tinnitus has come from damage to the higher frequencies.

Do we know if people like me are in the clinical trials and if FX-322 will help with those higher frequencies? Or have they just picked people with really poor hearing?

The only answer is we can't know for sure, but there is a lot of anecdotal evidence to suggest that treating hearing loss can improve (and perhaps cure) noise-induced tinnitus. For example, there are many out there with hearing loss, including people on this forum, who have screeching tinnitus, but see their tinnitus improve once they put their hearing aids in. This would suggest then that there is some kind of relationship between hearing loss and tinnitus. And FX-322 is fundamentally designed to treat hearing loss above all else.

Coming now to your audiograms... Audiograms, in their existing form, are codswallop, to put it mildly. They barely measure half of the human frequency spectrum for a start and do not demonstrate synapse loss. A word-in-noise test is far more indicative of the state of someone's hearing. I am so tired of every ENT and audiologist out there telling people like us, including yourself, that we have good/perfect hearing. When I pushed one of my ENTs on why they measure only up to 8,000 Hz or so, he said this: "high-frequency measurements are of academic interest only". Way to write off thousands of years of human evolution right there! Seeing as you don't need half of your cochlea, can I have it instead?

Anyway, my rant above aside, there is no reason why FX-322 may not help you given that your audiogram, for what it's worth, isn't showing any issues with your OHCs in those given frequencies. It's possible your tinnitus is the result of ultra high-frequency hearing loss, as you are suggesting, or cochlear synaptopathy. I don't think we can say for sure whether cochlear synaptopathy loss "mirrors" audiogram loss, so it's possible that synaptopathy could be anywhere. In that case, you may still see some benefit from FX-322 if you have synapse loss where you also have hair cell loss. Otherwise, a drug such as OTO-413 would be more suited to you.

 

[FGG]

Not to get political on you, but it was the Obama/Biden administration that brought the last significant "renovation" to the FDA that brought incentives like the Breakthrough Therapy Status. As VP, Biden was a proponent of accelerating programs for treating cancer and other terminal diseases. Promising Pathways Act may see some acceleration under Biden, but probably not soon enough to affect the progress of FX-322.

However, I did notice today that Biden elevated the Science Office to a Cabinet Level position. This may lead to other legislation that promotes the FDA using more common-sense, good-science based decision-making. It may also just be virtue signaling that the Administration will be taking science seriously for a change.

Biden will elevate White House science office to Cabinet-level

Wow, having a new cabinet position: science officer is huge. Will be interesting to see what comes of it...