Frequency Therapeutics — Hearing Loss Regeneration

[xyz]

I'm in the same spot like you... I keep updating the attached sheet... I'll share with you...

View attachment 38297

Interesting. So there is a test to check the condition of hair cells with the "Otoemission DPOAE".

Has anybody had this test done? How is it performed? Probably it is not available at the ordinary ENT.

 

[FGG]

Interesting. So there is a test to check the condition of hair cells with the "Otoemission DPOAE".

Has anybody had this test done? How is it performed? Probably it is not available at the ordinary ENT.

I had it done. It checks outer hair cell function up to 8000Hz, like the audiogram. It basically checks if they are normal or abnormal.

It's widely available in the US at least.

 

[xyz]

I had it done. It checks outer hair cell function up to 8000Hz, like the audiogram. It's widely available in the US at least.

Ok, so if the normal audiogram comes out 100%, then DPOAE will possibly not detect any finer hair cell damages?

 

[Jack V]

It seems to me that the treatments (if and when they happen) are more impressive than the tests.

Therefore, as long as a treatment is safe, and doesn't preclude future treatments of a different kind, I'm inclined to try this or any treatment that seems like it might help.

 

[FGG]

Ok, so if the normal audiogram comes out 100%, then DPOAE will possibly not detect any finer hair cell damages?

I had it done to see if my 250Hz dip was due to OHC loss or something like hydrops when they suspected Meniere's. Since it was normal, they assumed it was not OHC loss (I probably had a secondary hydrops of some sort). In my case, they used it to get more information about my dip. I'm not sure if it can be used another way.

 

[FGG]

It seems to me that the treatments (if and when they happen) are more impressive than the tests.

Therefore, as long as a treatment is safe, and doesn't preclude future treatments of a different kind, I'm inclined to try this or any treatment that seems like it might help.

Now that there are treatments coming out, there is a reason for improved diagnostics. When mostly all you had was hearing aids (and Meniere's treatments), all you needed was a standard audiogram but that is rapidly becoming way too primitive.

I really hope there is research being done for better diagnostics (including brainstem ion channels in my particular case with Macrolides), but I don't see much in that regard.

 

[MrCrybaby]

Now that there are treatments coming out, there is a reason for improved diagnostics. When mostly all you had was hearing aids (and Meniere's treatments), all you needed was a standard audiogram but that is rapidly becoming way too primitive.

I really hope there is research being done for better diagnostics (including brainstem ion channels in my particular case with Macrolides), but I don't see much in that regard.

Once regeneration hits the market I think we'll start seeing action in that area. It's bad business to develop tests before the treatment is approved, even though it's common sense from a patient perspective.

 

[FGG]

I'm in the same spot like you... I keep updating the attached sheet... I'll share with you...

View attachment 38297

That's a really nice, succinct summary but just to clarify, Otoacoustic emissions checks just outer hair cells, and ABR checks parts of the brainstem, too depending on the waves measured. ABR may also be affected by synaptopathy as well in certain conditions.

 

[Jorge1984]

I'm in the same spot like you... I keep updating the attached sheet... I'll share with you...

View attachment 38297

I would like to make some suggestions that I hope you will positively receive.

Change the following:

- "Remarks" to "What it tests"
- "Scan" to "brain imaging"
- "Audiogram" under remarks to "Hearing test"

I would also like to suggest that you add a column titled "Tinnitus Cause" and then fill in with with the appropriate causes that each is testing.

Lastly, I would like to suggest that you join the lower info box to the upper info box and associate each proposed drug with the appropriate underlying condition.

Again, thank you @ThomasRobert. Good to see this information in one place.

 

[FrontRoomFanatic]

I'm in the same spot like you... I keep updating the attached sheet... I'll share with you...

View attachment 38297

What is the third picture of the hair cell depicting? Is it following treatment from FX-322?

Only reason I'm doubting that is what it's depicting is that it's repaired the synapses so I'm thinking I'm wrong?

 

[Diesel]

Has anyone had a chance to look at the more recent patents submitted by Frequency that are published at the USPTO site? Looks a few new ones have been added since my last post...

A few published in March related to cochlear hair cell progenitors. The most recent one relates to activating progenitors for actual hair follicle cells. Interesting that they're branching out.

http://appft.uspto.gov/netacgi/nph-...peutics&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PG01

 

[serendipity1996]

Has anyone had a chance to look at the more recent patents submitted by Frequency that are published at the USPTO site? Looks a few new ones have been added since my last post...

A few published in March related to cochlear hair cell progenitors. The most recent one relates to activating progenitors for actual hair follicle cells. Interesting that they're branching out.

http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/PTO/search-bool.html&r=0&f=S&l=50&TERM1=frequency+therapeutics&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PG01

Good find - I think Frequency has said they ultimately intend to use their progenitor cell activation technology for a multitude of disorders although of course they're currently mainly focusing on the ear. Also seems like an encouraging sign and signals a degree of confidence in their approach - don't think they would be branching out like this if they were underwhelmed by preliminary results from hearing platform.

 

[FGG]

Has anyone had a chance to look at the more recent patents submitted by Frequency that are published at the USPTO site? Looks a few new ones have been added since my last post...

A few published in March related to cochlear hair cell progenitors. The most recent one relates to activating progenitors for actual hair follicle cells. Interesting that they're branching out.

http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/PTO/search-bool.html&r=0&f=S&l=50&TERM1=frequency+therapeutics&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PG01

They had mentioned in a conference before eventually using their technology to treat baldness and cartilage disorders. They seem really confident about their platform.

 

[Diesel]

They had mentioned in a conference before eventually using their technology to treat baldness and cartilage disorders. They seem really confident about their platform.

If the first product works for me, looks like I may be a return customer...

 

[Lucifer]

If the first product works for me, looks like I may be a return customer...

I hope FX-322 works for me too. It might be something I take yearly.

 

[Danad]

Below is a link to a paper on the stochastic resonance model of tinnitus; claiming reduced auditory input as the main culprit. More promising info for the potential of FX-322 to curb tinnitus.

https://www.biorxiv.org/content/10.1101/2020.03.27.011163v1.full.pdf

 

[Mr.tdog15]

If we do this procedure once, do we have to do it again and again or is it that once it regenerates hair cells it'll keep them that way?

 

[FGG]

If we do this procedure once, do we have to do it again and again or is it that once it regenerates hair cells it'll keep them that way?

Are you asking whether regenerated cells later die? There is no evidence that that's a problem.

 

[serendipity1996]

If we do this procedure once, do we have to do it again and again or is it that once it regenerates hair cells it'll keep them that way?

It seems like it would be a one-off procedure in that the effects would be permanent but I can imagine that if you have, say, a greater degree of hearing loss it may require multiple sessions.

 

[Mistertdog15]

Let's say this doesn't cure tinnitus (fingers crossed it does), are there any other pharmaceutical companies working on something that suppresses tinnitus as a whole? Or is that impossible?

 

[serendipity1996]

Let's say this doesn't cure tinnitus (fingers crossed it does), are there any other pharmaceutical companies working on something that suppresses tinnitus as a whole? Or is that impossible?

Check our Dr. Thanos Tzounopoulos' work, he's developing an ion-channel drug to suppress tinnitus.

 

[FGG]

Let's say this doesn't cure tinnitus (fingers crossed it does), are there any other pharmaceutical companies working on something that suppresses tinnitus as a whole? Or is that impossible?

FX-322 only works for hair cell damage, so it wouldn't work for all tinnitus just a common cause of it. As discussed here before, even within the cochlea you could still have synaptopathy as a cause but other drug companies are working on this.

Regeneration drugs as a class would not address tinnitus from: ETD, PLF, conductive losses, ear drum pathology, severe losses where support cells have been depleted (yet), head/neck injury, TMJ etc etc.

It's always better to treat the underlying cause when possible but as to your question of suppression more generally, that's the aim of bimodal stimulation among other things.

 

[Jorge1984]

Let's say this doesn't cure tinnitus (fingers crossed it does), are there any other pharmaceutical companies working on something that suppresses tinnitus as a whole? Or is that impossible?

Susan Shore, and Hough Ear Institute pill are looking pretty promising. I'm looking forward towards the Hough Ear Institute pill because for a fact I know my tinnitus is caused because of my broken synapses and it will regenerate them.

 

[Jack V]

As I understand it, there might not be a phase 3 trial. The drug has been fast-tracked by the FDA, and I believe they are also applying for 'breakthrough therapy' status. Meaning it could go straight to the market if approved.

Even if there were a phase 3 trial, I think it's unlikely that we won't be over this coronavirus stuff when the time comes. Of course, others might crucify me for being so optimistic!

As I understand it, there are cases where the FDA has permitted a drug to go to market prior to Phase 3 trials given overwhelming evidence of efficacy following Phase 2 trials. The idea is that if the drug has already proven overwhelmingly effective at reducing suffering for its target population during Phase 2, there's an ethical urgency to provide it to them. However, Phase 3 trials continue even as the drug is made available to the public, with the FDA reserving the right to reverse their decision should contradictory data emerge.

 

[GlennS]

Susan Shore, and Hough Ear Institute pill are looking pretty promising. I'm looking forward towards the Hough Ear Institute pill because for a fact I know my tinnitus is caused because of my broken synapses and it will regenerate them.

Or so they say. The proof is always in the pudding. Notice how quiet the Lenire thread is these day after so much early optimism.

 

[Lucifer]

As I understand it, there are cases where the FDA has permitted a drug to go to market prior to Phase 3 trials given overwhelming evidence of efficacy following Phase 2 trials. The idea is that if the drug has already proven overwhelmingly effective at reducing suffering for its target population during Phase 2, there's an ethical urgency to provide it to them. However, Phase 3 trials continue even as the drug is made available to the public, with the FDA reserving the right to reverse their decision should contradictory data emerge.

I really hope that's the case. I want FX-322 to be released asap.

 

[AtlasFainted]

As I understand it, there are cases where the FDA has permitted a drug to go to market prior to Phase 3 trials given overwhelming evidence of efficacy following Phase 2 trials. The idea is that if the drug has already proven overwhelmingly effective at reducing suffering for its target population during Phase 2, there's an ethical urgency to provide it to them. However, Phase 3 trials continue even as the drug is made available to the public, with the FDA reserving the right to reverse their decision should contradictory data emerge.

This can happen for any drug, not just the ones which are designated as a breakthrough therapy?

While I hope this happens, I'm a little concerned with the drug not reaching into the lower frequencies. While I strongly believe it should be approved even if it only affects frequencies that are > 6-8kHz, conventional practice (as well as audiograms) tend to only see those lower frequencies as important.

Ideally the drug will show to be more effective during phase 2, or at least all of the people who are in charge of early approval will realize that restoring the higher frequencies is actually more important for millions of individuals.

Personally I think healing those higher frequencies will actually fix tinnitus for more people than healing the lower ones. The fact that this drug isn't being tested primarily for tinnitus-related efficacy is what has me worried.

 

[AtlasFainted]

Susan Shore, and Hough Ear Institute pill are looking pretty promising. I'm looking forward towards the Hough Ear Institute pill because for a fact I know my tinnitus is caused because of my broken synapses and it will regenerate them.

How do you know your tinnitus is due to broken synapses and not hair cell loss? This has always been a grey area for me as far as knowing which one is more responsible for my hearing issues.

 

[serendipity1996]

How do you know your tinnitus is due to broken synapses and not hair cell loss? This has always been a grey area for me as far as knowing which one is more responsible for my hearing issues.

Yeah, to me it seems like the regeneration side of things is really outpacing the diagnostics which are still pretty crude and inadequate.

 

[Diesel]

This can happen for any drug, not just the ones which are designated as a breakthrough therapy?

While I hope this happens, I'm a little concerned with the drug not reaching into the lower frequencies. While I strongly believe it should be approved even if it only affects frequencies that are > 6-8kHz, conventional practice (as well as audiograms) tend to only see those lower frequencies as important.

Ideally the drug will show to be more effective during phase 2, or at least all of the people who are in charge of early approval will realize that restoring the higher frequencies is actually more important for millions of individuals.

Personally I think healing those higher frequencies will actually fix tinnitus for more people than healing the lower ones. The fact that this drug isn't being tested primarily for tinnitus-related efficacy is what has me worried.

I for one support tinnitus-related efficacy not being a primary outcome of the study. Too much subjectivity; too many unknowns about the cause of tinnitus. Restoring hearing using common and accepted metrics by clinicians is the better metric to get FX-322 to the market effectively; and based on the Phase 1/2, it looks promising.

One thing I think we can know for nearly certain is that FX-322 didn't make tinnitus worse for any patients during the Phase 1/2. If tinnitus worsened for only a handful of participants, the FDA would not have considered it safe, and would not have allowed Frequency to continue to a Phase 2a.

The two outcomes I will be looking for on the Phase 2a are extended audiogram improvements (8kHz - 16kHz), and a reduction in Tinnitus Functional Index by participants that received FX-322. If these two show improvements at significant levels, then it stands to reason that restoring hair cells reduces tinnitus symptoms for folks with Noise-Induced hearing loss. In my opinion, this discovery would be a groundbreaking finding for folks with tinnitus.

Also... Carl LeBel of Frequency agreeing to join a Tinnitus Talk Podcast sure is telling...