Frequency Therapeutics — Hearing Loss Regeneration

[FGG]

The fact that they're planning ahead for a pivotal trial in 2022 seems promising. Honestly, I wasn't expecting that any of the drugs currently in development would get there quite so soon.

I'm wondering if FX-322 would be helpful for me, though. According to my audiologist my (extended) audiogram and word recognition scores look fine, which doesn't seem to indicate sensorineural hearing loss.

Considering my audiogram, would cochlear synaptopathy be the likely culprit of my tinnitus?

Looks like they stopped at 12.5 kHz. Any chance you could test up to 16 kHz? It's possible your problem may be more synaptopathy but it doesn't appear you got a full extended audiogram.

 

[iwillbestrong]

@cjbhab I wouldn't assume that at all. Especially since they basically shit on standard audiograms in a recent post. Someone shared it in this thread before, on the previous page.

 

[WickedCarnival]

Today's event link:

The Potential for Restorative Treatments for Acquired Sensorineural Hearing Loss

 

[patorjk]

The fact that they're planning ahead for a pivotal trial in 2022 seems promising. Honestly, I wasn't expecting that any of the drugs currently in development would get there quite so soon.

I'm wondering if FX-322 would be helpful for me, though. According to my audiologist my (extended) audiogram and word recognition scores look fine, which doesn't seem to indicate sensorineural hearing loss.

Considering my audiogram, would cochlear synaptopathy be the likely culprit of my tinnitus?

We're in uncharted waters with this question. No one really knows. Right now FX-322 has promise for reducing tinnitus, and if that turns out to be true, then there's probably a cochlear synaptopathy element to tinnitus too. But it would be surprising if someone's tinnitus was caused by just 1 of these factors, and it may turn out that there are other factors that we're just not aware of yet.

 

[patorjk]

I don't know why I haven't thought of this before, but I develop and execute cold outbound marketing campaigns and could very feasibly identify, scrape and email every ENT in the U.S. a 'request' to pay attention to this. Maybe I'll start in my local market as a test. I could do the same to Audiologists for Lenire, Audiologists who drive Teslas and even Tesla owners who have hearing problems. Love me a good customer archetype.

You may run into trouble with this. Frequency Therapeutics and the other companies involved may not appreciate this approach, as it could alienate some ENTs.

Also, I wouldn't lump all of these treatments together.

Personally I think Lenire is based on junk science, and the fact that they didn't have a placebo group in their study makes their study worthless to me - you just have to look at the 2017 OTIVIDEX phase 3 study to see how powerful the effect can be. It's not in the same class as FX-322. However, time will tell.

 

[Drachen]

You may run into trouble with this. Frequency Therapeutics and the other companies involved may not appreciate this approach, as it could alienate some ENTs.

It's also important to keep in mind that Frequency Therapeutics are already working on the monumental task it will be to educate medical professionals about their drug, how to administer it, in which cases it is best used, etc.

I'm sure as the days get closer to market release, they will start working on disseminating pertinent information and getting the world ready for this revolutionary development.

 

[Diesel]

I had initially wondered if Frequency Therapeutics would announce the Phase 2A 90-day readout at the upcoming Cowen 2021 conference in March... However, now that we've seen them conduct this pretty polished video-based webinar; I wonder if they'll just host the release themselves? They had complete control hosting their own event, and I could see them doing the same for the 90-day results. This would give them the ability to present the data, provide an in-depth analysis, and answer direct Q&As from a live audience. Would be really compelling content in a 90-minute session.

 

[Philip83]

I wish I could but my TTTS disqualifies me. My dad however fits the bill perfectly. I think the more people that this forum can get into the trial, the better.

And the faster the trial fills up, the faster it gets completed and FX-322 becomes available.

Where did you find the information that TTTS disqualifies you? And how do you get that diagnosed?

 

[Danad]

Firstly, let's talk about the stock, one of the few times in life that free $$ was staring you in the face. Having researched FX-322 to death I bought a ton following the IPO and I'm risk averse (still rather have no tinnitus than 8 figures though).

Secondly, Dr Lustig's reply concerning expectations with tinnitus was more like a prayer than an informed response as if hearing loss/restoration and tinnitus is totally unrelated. Not impressed.

Thirdly, Frequency Therapeutics will plan on a pivotal trial in 2022 but it doesn't preclude early commercial access with Breakthrough Therapy status. Remember some drugs DO go to market following Phase 2.

 

[FGG]

Thirdly, Frequency Therapeutics will plan on a pivotal trial in 2022 but it doesn't preclude early commercial access with Breakthrough Therapy status. Remember some drugs DO go to market following Phase 2.

This is pure speculation but wouldn't Frequency Therapeutics likely have some idea if they were going to get Breakthrough Therapy designation or not. Fast Track means they are meeting frequently with the FDA so I would think there was some talk back and forth.

Just an assumption and maybe I'm off base there.

 

[Diesel]

Secondly, Dr Lustig's reply concerning expectations with tinnitus was more like a prayer than an informed response as if hearing loss/restoration and tinnitus is totally unrelated. Not impressed.

I AM SO GLAD YOU BROUGHT THIS UP! Lustig reminded me of the "institution" not ready to accept the paradigm shift happening with FX-322... It was like he had a dissenting opinion that Age-Related hearing loss wasn't really largely hair cell loss, and I totally agree on the tinnitus comment.

 

[Drachen]

Firstly, let's talk about the stock, one of the few times in life that free $$ was staring you in the face. Having researched FX-322 to death I bought a ton following the IPO and I'm risk averse (still rather have no tinnitus than 8 figures though).

Honestly, I am really concerned with this. I am worried that I am staring an early days Apple stock or Bitcoin investment in the face and not jumping on the opportunity. If this drug does pan out, and everything seems to be indicating that it will, there's no way this stock doesn't jump to insane value. Their success would be revolutionary on a species-wide scale.

Secondly, Dr Lustig's reply concerning expectations with tinnitus was more like a prayer than an informed response as if hearing loss/restoration and tinnitus is totally unrelated. Not impressed.

I can't believe that they don't understand there is a clear and honest connection between the two. Research has considerably hinted at this being the case. I'm wondering if it's a combination of two factors: 1) you're really not going to know for sure until the data comes out, because they are in uncharted waters with how far they've gotten, and 2) they still aren't exactly focusing on tinnitus as an outcome since first and foremost this is about hearing loss. These guys are known for being ultra-conservative, and once they have data, I imagine they will confidently provide evidence for the connection.

 

[dd314]

Possibly slightly off-topic, but as far as the relationship between hearing loss and tinnitus goes, I have a question.

How is "perfect hearing" + tinnitus even possible? How would a person be able to detect an external noise that is already being subjectively perceived? Any thoughts on this? I have "perfect hearing" according to an audiologist and I'd like to remain optimistic about hearing restoration.

 

[Lucifer]

Firstly, let's talk about the stock, one of the few times in life that free $$ was staring you in the face. Having researched FX-322 to death I bought a ton following the IPO and I'm risk averse (still rather have no tinnitus than 8 figures though).

Secondly, Dr Lustig's reply concerning expectations with tinnitus was more like a prayer than an informed response as if hearing loss/restoration and tinnitus is totally unrelated. Not impressed.

Thirdly, Frequency Therapeutics will plan on a pivotal trial in 2022 but it doesn't preclude early commercial access with Breakthrough Therapy status. Remember some drugs DO go to market following Phase 2.

Danad, that's why I was wondering whether the pivotal trial was a conservative approach and they could potentially release FX-322 out to the market next year after they have completed Phase 2a clinical trials while still completing their pivotal trial in 2022.

 

[Drachen]

I have "perfect hearing" according to an audiologist and I'd like to remain optimistic about hearing restoration.

"Perfect hearing" is a myth, I think. I don't believe it to be possible that any adult can have perfect hearing across all ranges. Pretty sure the clock starts ticking on that from birth, and given how loud modern society is, I'm sure that's all the more valid. Perhaps if you lived in the wilds or some remote village far disconnected from society, you might have as close to it as possible, but there's still natural wear-and-tear going on.

Audiograms are not robust enough to detect your proficiency across the entire range of human hearing. Getting a "perfect" score on an audiogram is not bad, since it does detect performance at critical ranges, but it is by no means a gold standard.

 

[serendipity1996]

I AM SO GLAD YOU BROUGHT THIS UP! Lustig reminded me of the "institution" not ready to accept the paradigm shift happening with FX-322... It was like he had a dissenting opinion that Age-Related hearing loss wasn't really largely hair cell loss, and I totally agree on the tinnitus comment.

What did he say specifically? That there's no conclusive link between hearing loss and tinnitus?

 

[Diesel]

Possibly slightly off-topic, but as far as the relationship between hearing loss and tinnitus goes, I have a question.

How is "perfect hearing" + tinnitus even possible? How would a person be able to detect an external noise that is already being subjectively perceived? Any thoughts on this? I have "perfect hearing" according to an audiologist and I'd like to remain optimistic about hearing restoration.

I'd love to see your "perfect hearing" audiogram from 125 Hz - 16 kHz.

If it's not been tested above 8 kHz, then you don't have the whole picture of your hearing.

Also, audiogram tones are extremely narrow considering the broad spectrum of hearing our ears have.

 

[Philip83]

Possibly slightly off-topic, but as far as the relationship between hearing loss and tinnitus goes, I have a question.

How is "perfect hearing" + tinnitus even possible? How would a person be able to detect an external noise that is already being subjectively perceived? Any thoughts on this? I have "perfect hearing" according to an audiologist and I'd like to remain optimistic about hearing restoration.

Like has been stated on nearly every page of this thread, "perfect hearing" according to today's medical measurement standards means very little.

 

[Drachen]

I AM SO GLAD YOU BROUGHT THIS UP! Lustig reminded me of the "institution" not ready to accept the paradigm shift happening with FX-322... It was like he had a dissenting opinion that Age-Related hearing loss wasn't really largely hair cell loss, and I totally agree on the tinnitus comment.

How worrisome is this? The last thing we need right now is a rotten egg poisoning the informational game plan going forward. I would have to assume any of his "doubts" would be reversed by positive results... right?

 

[Diesel]

How worrisome is this? The last thing we need right now is a rotten egg poisoning the informational game plan going forward. I would have to assume any of his "doubts" would be reversed by positive results... right?

I think it's classic foot-in-mouth on-camera. I've seen the smartest of people do it, some just can't get out of their own way to debate themselves. He's not wrong that tinnitus can be a tough one to nail down a treatment for, but in the case of recruited patients that clearly have it as a SNHL symptom, they should see some relief.

I'm honestly not worried about it. I think he reacted to FX-322 being viewed as a "cure" for broad tinnitus. But the answer should have specified that it may be a treatment to provide some with relief.

 

[Danad]

What did he say specifically? That there's no conclusive link between hearing loss and tinnitus?

Below is Dr Lustig's audio snippet from presentation around 1:16:30. He made no mention of hearing loss leading to tinnitus nor of hearing restoration's effects on said disorder. Sounds like he has felt powerless for so long to help countless patients with this that he's given up on it. Certainly he has not kept up on the latest studies.

 

[Aaron91]

I have "perfect hearing" according to an audiologist and I'd like to remain optimistic about hearing restoration.

For 99% of audiologists out there, their opinion isn't worth the paper they write their diagnosis on.

That said, I can't speak highly enough of my own audiologist. She told me she has been hoping for a regenerative drug for years because her own father requires hearing aids. She then went on to say that whenever she goes to an audiologist/hearing loss conference, all the audiologists say the same thing to her: "Why on earth would you want a cure for hearing loss? If that happens, we're all out of a job".

And I can't wait for the day they all are.

 

[patorjk]

So there's always a lot of talk when insiders sell, but today it looks like insiders exercised their stock options and obtained more stock. Most interestingly, Christopher Loose, who's sold quite a bit of stock, acquired 70k shares:

https://investors.frequencytx.com/node/7386/html

I'm pretty amateur when it comes to reading these things, but it looks like he acquired the shares for $0. It makes me wonder how many more options he has - or maybe options were given to board members recently?

Whatever the case, it shows the amount of shares the insiders have isn't completely fixed. Someone like Chris can always get more shares through options.

 

[Koz]

She then went on to say that whenever she goes to an audiologist/hearing loss conference, all the audiologists say the same thing to her: "Why on earth would you want a cure for hearing loss? If that happens, we're all out of a job".

That's disgusting. I'd be infuriated but no, more so disgusted. The main duty of any health professional is helping restore health and solve health related problems, not hide it under the carpet and send them home with a lollipop.

 

[Orions Pain]

For 99% of audiologists out there, their opinion isn't worth the paper they write their diagnosis on.

That said, I can't speak highly enough of my own audiologist. She told me she has been hoping for a regenerative drug for years because her own father requires hearing aids. She then went on to say that whenever she goes to an audiologist/hearing loss conference, all the audiologists say the same thing to her: "Why on earth would you want a cure for hearing loss? If that happens, we're all out of a job".

And I can't wait for the day they all are.

I don't like to wish bad things onto people but whoever makes comments like this deserves to be out of a job. I know they probably didn't think before speaking but to hope others suffer just so you continue to make money... man.

 

[FGG]

Anyone else catch around the 12 min mark where Langer says their molecules could repair damaged or destroyed hair cells?

That question gets asked every few pages on this thread so I wanted to highlight it.

 

[Diesel]

For 99% of audiologists out there, their opinion isn't worth the paper they write their diagnosis on.

That said, I can't speak highly enough of my own audiologist. She told me she has been hoping for a regenerative drug for years because her own father requires hearing aids. She then went on to say that whenever she goes to an audiologist/hearing loss conference, all the audiologists say the same thing to her: "Why on earth would you want a cure for hearing loss? If that happens, we're all out of a job".

And I can't wait for the day they all are.

The thing is, they won't be. They'll be busier than ever. Frequency Therapeutics hit the nail on the head discussing the market of millions of people who have hearing loss in just the US. They discuss the current state of the patient population, and why they don't visit audiologists: they don't want/prefer hearing aids, they're not aware of their hearing problem, they don't want to acknowledge it, or they're already aware audiologists can't help them.

When there is a drug to treat these conditions, interest by that 80% of patients that aren't helped by hearing aids is going to overwhelm their offices. Especially those that need an audiologist to get a referral to an ENT for the injection.

In my career and personally, I have learned that doctors aren't always the most entrepreneurial types, they don't think about gaining the edge; they go by book. Perhaps that's why many see this resistance to the shift, they only look back at what is known and not what could be possible.

Frequency Therapeutics has a lot of work to do in this area.

 

[serendipity1996]

The thing is, they won't be. They'll be busier than ever. Frequency Therapeutics hit the nail on the head discussing the market of millions of people who have hearing loss in just the US. They discuss the current state of the patient population, and why they don't visit audiologists: they don't want/prefer hearing aids, they're not aware of their hearing problem, they don't want to acknowledge it, or they're already aware audiologists can't help them.

When there is a drug to treat these conditions, interest by that 80% of patients that aren't helped by hearing aids is going to overwhelm their offices. Especially those that need an audiologist to get a referral to an ENT for the injection.

In my career and personally, I have learned that doctors aren't always the most entrepreneurial types, they don't think about gaining the edge; they go by book. Perhaps that's why many see this resistance to the shift, they only look back at what is known and not what could be possible.

Frequency Therapeutics has a lot of work to do in this area.

Yeah, I think audiologists will still perform an important function (e.g. in administering hearing tests etc) once regenerative meds come out and I totally agree that the current standard of care is off-putting to many people. It's so disheartening that some audiologists have actually expressed that they don't welcome a cure for hearing loss. Like I get that doctors can be resistant to change etc but it's just such a knee-jerk, arrogant reaction to have.

 

[Drachen]

The thing is, they won't be. They'll be busier than ever.

Yeah, I think audiologists will still perform an important function (e.g. in administering hearing tests etc) once regenerative meds come out and I totally agree that the current standard of care is off-putting to many people.

If this is the case, then I think this is better in the long run. If audiologists don't feel threatened by the new science, they are less likely to push back against it. Hell, if they could get brought over to the side of regenerative medicine, that would bode well for the future of access and education of the science.

I think the only ones that have any legitimate worry would be the hearing aid corporations. I'm honestly worried about any attempts they might make to impede the progress of FX-322 or regenerative medicine in general. If these drugs are priced at or better than the cost of hearing aids, then hearing aids are going to be almost entirely obsolete.

 

[Diesel]

Yeah, I think audiologists will still perform an important function (e.g. in administering hearing tests etc) once regenerative meds come out and I totally agree that the current standard of care is off-putting to many people. It's so disheartening that some audiologists have actually expressed that they don't welcome a cure for hearing loss. Like I get that doctors can be resistant to change etc but it's just such a knee-jerk, arrogant reaction to have.

I think what we'll see, and Frequency Therapeutics has outlined this somewhat, is the concept of annual hearing checkups. Someone like us will come in with a problem like tinnitus, get a more comprehensive hearing test (and charged more), then get the FX-322 series of injections based on the assessment. From there, the ENT will recommend annual visits to check on wear of hearing, and determine if another round is needed. This will be no different than glasses where people have eye exams every so often to get their lenses/contacts updated.

It's an awesome opportunity to have a patient for life and keep their hearing at optimal condition. Right now, it's really just managing decay.