Frequency Therapeutics — Hearing Loss Regeneration

[Philip83]

Even if it is developed as a speech understanding drug, this is still helping with hearing loss even if there is no improvement on the audiogram. One such argument is that it is triggering the inner hair cells which deal with this.

Pure speculation, but I think ear "strength" and "health" more broadly could benefit in any case (noxacusis, TTTS, inflammation, irritation, fullness...). In general, if you repair/improve individual parts in any integrated system, the whole system usually benefits.

 

[Pero1234]

I think "fixing" speech in noise is a valuable first step in curing hearing loss.

Not only will it help many people and become commercially viable...

It will show investors that therapeutic hearing loss companies / scientists are on the right track. Growing interest...

 

[Lucifer]

Even if it is developed as a speech understanding drug, this is still helping with hearing loss even if there is no improvement on the audiogram. One such argument is that it is triggering the inner hair cells which deal with this.

Also have to take into account that when they did the audiogram tests, the maximum they tested was 8 kHz. If they had tested up to 20 kHz there would have been bound to have some improvements at the higher frequencies.

I still believe that the patients who have experienced an improvement in speech in the trials should have experienced improvements in their audiograms but weren't tested up to 20 kHz.

 

[Tau]

I still believe that the patients who have experienced an improvement in speech in the trials should have experienced improvements in their audiograms but weren't tested up to 20 kHz.

It could also be that they had had their synapses regrown, which does not impact PTA.

 

[Philip83]

Also have to take into account that when they did the audiogram tests, the maximum they tested was 8 kHz. If they had tested up to 20 kHz there would have been bound to have some improvements at the higher frequencies.

I still believe that the patients who have experienced an improvement in speech in the trials should have experienced improvements in their audiograms but weren't tested up to 20 kHz.

Actually, I think they did test up to 18 or 20 kHz in Phase 2, but I'm too lazy to try and find where they stated that. Also, I don't think they ever released any results of pure tone tests at all from Phase 2, or did they?

 

[Pero1234]

My audiologist contacted me out of the blue, to come in for some additional free tests. And to compare my audiogram to that of three years ago.

Apparently they have new equipment they want to try out on people diagnosed with tinnitus. I suspect they hope to sell some more hearing aids, but anyway… was pleasantly surprised by them reaching out.

Curious what additional gear they have now… tests above 8 kHz? Or speech in noise?

 

[Philip83]

My audiologist contacted me out of the blue, to come in for some additional free tests. And to compare my audiogram to that of three years ago.

Apparently they have new equipment they want to try out on people diagnosed with tinnitus. I suspect they hope to sell some more hearing aids, but anyway… was pleasantly surprised by them reaching out.

Curious what additional gear they have now… tests above 8 kHz? Or speech in noise?

Let us know!

 

[Joeseph Stope]

My audiologist contacted me out of the blue, to come in for some additional free tests. And to compare my audiogram to that of three years ago.

Apparently they have new equipment they want to try out on people diagnosed with tinnitus. I suspect they hope to sell some more hearing aids, but anyway… was pleasantly surprised by them reaching out.

Curious what additional gear they have now… tests above 8 kHz? Or speech in noise?

I believe you are a product of Belgium/Holland/Lux. Isn't that where the well-known tinnitus expert, Dirk de Ridder who gave a podcast for us, spends his time for part of the year?

Who knows, he might have something to do with it. The tinnitus experts are a small community and most likely they know one another and help one another on projects.

As they say,
"The thick plottens".

 

[Lucifer]

Actually, I think they did test up to 18 or 20 kHz in Phase 2, but I'm too lazy to try and find where they stated that. Also, I don't think they ever released any results of pure tone tests at all from Phase 2, or did they?

I'm not sure but I know in Phase 1 they only went up to 8 kHz. It would have been nice to see if there were any improvements in audiogram at the higher frequencies.

 

[Philip83]

I'm not sure but I know in Phase 1 they only went up to 8 kHz. It would have been nice to see if there were any improvements in audiogram at the higher frequencies.

Here it is from (https://clinicaltrials.gov/ct2/show/NCT04120116):

Secondary Outcome Measures :

1. Extended High Frequency Pure Tone Audiometry [ Time Frame: Screening to Day 210 ]
   Pure tone audiometry will be measured to determine a subject's threshold for hearing at extended high range frequencies (Hz)

So they do specify that they were testing "extended high range", which I can only assume would mean past 8 kHz. Does not seem to mention exactly how high though.

I believe the statement about that none of the patients showed any improvement in PTA was a verbal one made by Lucchino during their webinar in September.

 

[Diesel]

Here it is from (https://clinicaltrials.gov/ct2/show/NCT04120116):

So they do specify that they were testing "extended high range", which I can only assume would mean past 8 kHz. Does not seem to mention exactly how high though.

I believe the statement about that none of the patients showed any improvement in PTA was a verbal one made by Lucchino during their webinar in September.

Extended High Frequency Audiogram = 8 kHz - 16 kHz.

 

[Gb3]

A new drug? What does this mean for FX-322?

 

[Diesel]

A new drug? What does this mean for FX-322?

FX-322 stays in the pipeline, at least through the current Phase 2B. If it shows positive outcomes in speech recognition, it moves to Phase 3.

This new compound, that little is known about, gets a new set of trials, starting with a Phase 1 safety validation.

 

[Philip83]

A new drug? What does this mean for FX-322?

Interesting. I wonder if it's a "new" drug, or FX-322 2.0.

 

[Street Novelist]

A new drug? What does this mean for FX-322?

That's probably years away from clinical trials. Has it even been developed yet? They would have to start from scratch, a Phase 1.

 

[Nobody19]

FX-322 stays in the pipeline, at least through the current Phase 2B. If it shows positive outcomes in speech recognition, it moves to Phase 3.

This new compound, that little is known about, gets a new set of trials, starting with a Phase 1 safety validation.

Progress will be incremental, like with many things. I do hope the FX-322 trials will be successful so they can get cash to fund more R&D.

 

[Trevor_phillips]

A new drug? What does this mean for FX-322?

The new drug could be a FX-322 with improved delivery method, so it can reach the cochlea more profoundly or a completely new drug with new compounds, new delivery method (I hope nanoparticles) and which can reach the cochlea from the apex to the base.

 

[Diesel]

Progress will be incremental, like with many things. I do hope the FX-322 trials will be successful so they can get cash to fund more R&D.

That appears to be the strategy. Otherwise, if this new compound was truly better, they would have canned FX-322 and just started a Phase 1 in 2022.

 

[tommyd87]

The new drug could be a FX-322 with improved delivery method, so it can reach the cochlea more profoundly or a completely new drug with new compounds, new delivery method (I hope nanoparticles) and which can reach the cochlea from the apex to the base.

There has already been a lot of development around nanoparticles and therefore it would seem a plausible and logical option.

 

[Joeseph Stope]

Time to blow off all the dust and cob-web off of my Scientific degree from all them years back. Ha! Me a scientist.

But a thought struck me one early morning.

The recent tests for FX-322 that went awry mentioned some participants on placebo who actually had improved test-scores after the placebo. Then there was the case on one of the Otonomy trials of (I hope this is correct), @ChrisBoyMonkey (?), who seemed to suffer a very distressful spike when he participated in OTO-313 trial... and it later turned out that he was on placebo.

Well to put it bluntly, maybe the scientists should focus some time on these outliers. How come the frequency placebo group improved their scores and @ChrisBoyMonkey (also on placebo) doing an OTO-313 trial seemed to suffer some sort of spike or trauma with his tinnitus?

Well, we call this a research thread, don't we? Maybe the outliers deserve scientific scrutiny too.

The way things look at the mo it seems the front-runners are "tapping in the dark".
I mentioned in an earlier post that the intratympanic development goes back to during the Second World War.

Well the 80s and 90s brought sound therapy, psychology and relaxation techniques.

Will the 2020s bring the long sought after breakthrough with regenerative medicine, gene technology or neuromodulation?

 

[tommyd87]

That's probably years away from clinical trials. Has it even been developed yet? They would have to start from scratch, a Phase 1.

They would, however they would reduce a lot of the lead time since a lot of the lead in work such as the preclinical studies etc is already completed.

Time to blow off all the dust and cob-web off of my Scientific degree from all them years back. Ha! Me a scientist.

But a thought struck me one early morning.

The recent tests for FX-322 that went awry mentioned some participants on placebo who actually had improved test-scores after the placebo. Then there was the case on one of the Otonomy trials of (I hope this is correct), @ChrisBoyMonkey (?), who seemed to suffer a very distressful spike when he participated in OTO-313 trial... and it later turned out that he was on placebo.

Well to put it bluntly, maybe the scientists should focus some time on these outliers. How come the frequency placebo group improved their scores and @ChrisBoyMonkey (also on placebo) doing an OTO-313 trial seemed to suffer some sort of spike or trauma with his tinnitus?

Well, we call this a research thread, don't we? Maybe the outliers deserve scientific scrutiny too.

The way things look at the mo it seems the front-runners are "tapping in the dark".
I mentioned in an earlier post that the intratympanic development goes back to during the Second World War.

Well the 80s and 90s brought sound therapy, psychology and relaxation techniques.

Will the 2020s bring the long sought after breakthrough with regenerative medicine, gene technology or neuromodulation?

Well wasn't the reason people improved in the FX-322 placebo group due to them falsifying their word scores to enter into the trial though? Then there seemed to also be the issue of Frequency Therapeutics possibly not going back far enough with patient related information and discovering that some of the people had oddities with the information they had provided.

That appears to be the strategy. Otherwise, if this new compound was truly better, they would have canned FX-322 and just started a Phase 1 in 2022.

Nothing to do with one compound being better than the other from what I see. Seems more like that Frequency Therapeutics believes there is merit in both compounds and that it is feasible they can get both of them approved also.

As a result they are trying to get the first one approved to offer benefit to people now.

 

[Lucifer]

I really hope they don't delay FX-322 from coming out by working on the new candidate. They should focus on releasing FX-322 in its current version first but also having separate trials on the new candidate so nothing gets delayed.

 

[Pinball]

I would love to see if there is any info on FX-322 regarding "stabilization". It would be such a relief to know if the drug had the potential to preserve hearing. For example - maintain your audiogram as is. I always hear how hearing will get worse over time and if I knew that this drug had the potential to protect my hearing as is - that would be amazing news.

 

[Nobody19]

I would love to see if there is any info on FX-322 regarding "stabilization". It would be such a relief to know if the drug had the potential to preserve hearing. For example - maintain your audiogram as is. I always hear how hearing will get worse over time and if I knew that this drug had the potential to protect my hearing as is - that would be amazing news.

Check for otoprotective medicine @Pinball, there are some in development.

 

[AfroSnowman]

Frequency Therapeutics Holds Virtual R&D Event Highlighting Clinical Advancement of FX-322, a New Potential Restorative Treatment for Hearing Loss and In Vivo Data for Its Remyelination Program in Multiple Sclerosis

Event Highlights:

FX-322

• Clinical data review from four completed FX-322 clinical studies, including 169 subjects with a range of hearing loss severities and SNHL etiologies (sudden, noise-induced, age-related).
• Analysis of statistically significant and clinically meaningful patient responses following a single FX-322 administration, establishing the range of severity and etiologies that will be explored in the upcoming FX-322-208 study.
• Review of design of ongoing FX-322-208 study, including use of multiple lead-in hearing measures implemented to reduce study bias and baseline variability.
• Alignment with the U.S. Food and Drug Administration around speech perception measures as a primary efficacy endpoint and the importance of speech perception as the key unmet need for individuals with SNHL.

FX-345

• Introduction of new SNHL investigational therapeutic program, including a more potent GSK3 inhibitor designed to achieve broader exposure of the cochlea.
• Preclinical pharmacokinetic measures and human modeling data, indicating that therapeutically active FX-345 drug levels will be reached in areas of the cochlea corresponding to a wider range of hearing frequencies.
• Potential to benefit an expanded SNHL patient population.
• IND anticipated in Q2 2022.

Remyelination in Multiple Sclerosis

• Identified novel therapeutic target that drives oligodendrocyte progenitor cell differentiation and myelination.
• FREQ-162, preclinical stage lead compound, induces substantially more remyelination than published, comparator approaches.
• FREQ-162 being advanced in preclinical safety studies toward the initiation of clinical development.

 

[Nobody19]

It's pretty awesome to see that they're able to improve their product already!

 

[RingingBrother]

It's pretty awesome to see that they're able to improve their product already!

I feel like it's going to progress similar to how when they made the first airplane and now we have fighter jets and newer versions being released. Also I'm sure when the first airplane failed to take off there was a lot of negativity and people saying we will never fly. Maybe one day Frequency Therapeutics will make a pill that can just fully restore all hearing in a matter of days.

 

[Gorbeh3]

Summary of this morning's presentation:

Encouraging results and they seem to have something here and be on the right path, but it is not a "golden ticket" at this time, there is much more work to be done but there is justification to be optimistic.

One of the biggest hurdles is delivery of the product so it reaches deeper into the cochlea. They are working to solve this.

Two individuals who receive FX-322 may see improvements at completely different times, someone may see improvements at one month and another maybe not until six months later.

Their focus is on noise induced and sudden sensorineural hearing loss. It appears it is least effective for age-related hearing loss.

I might have missed it if they did say anything because I was distracted towards the end but they said nothing regarding tinnitus or hyperacusis.

Best case scenario this will hit the market in 3-4 years, in my opinion.

Keep your heads up my tinnitus homies.

 

[Lucifer]

Did they say anything about severe hearing loss trial results?

 

[kiki]

"Clinical data review from four completed FX-322 clinical studies, including 169 subjects with a range of hearing loss severities and SNHL etiologies (sudden, noise-induced, age-related)."

Does this include clinical trials for severe hearing loss?