Frequency Therapeutics — Hearing Loss Regeneration

I think this is a fair assessment assuming the product is approved.

Best case scenario to get FX-322 to approval is that it performs well on the common hearing assessments currently used in the clinic for a specific group that stands to show consistent improvement, reliably.

Based on what we know from the Phase 1/2, that's a patient group with moderate - moderately severe hearing loss. As for severe, there may be more missing support cells, but perhaps the hair cell situation is even worse, so triggering regeneration in even some of the remaining support cells may provide a measurable benefit.
It will be interesting to see what they come up with in the next trial results. I think at that point they will know what they have.

I still think there is much more potential to FX-322 and they really need to figure out why they are not getting the results that they were expecting.
 
Frequency Therapeutics just tweeted a short age-related video.

Combine that and the AARP video a few weeks ago, and I hope they have good age-related results (which are imminent). They seem to at least want to highlight age-related loss.

They should have the data by now at least.
 
It will be interesting to see what they come up with in the next trial results. I think at that point they will know what they have.

I still think there is much more potential to FX-322 and they really need to figure out why they are not getting the results that they were expecting.
Agree. My own observation is that they are simply trying to cast too wide of a net for the first product. I acknowledge that it's a very "entrepreneurial" move to do so, and its clear they are ambitious about the product's potential. The only upside is this Severe trial; it may give them the data they need to clearly define a "1-dose patient."
 
Agree. My own observation is that they are simply trying to cast too wide of a net for the first product. I acknowledge that it's a very "entrepreneurial" move to do so, and its clear they are ambitious about the product's potential. The only upside is this Severe trial; it may give them the data they need to clearly define a "1-dose patient."
I think it's important for the placebo data to look like placebo data. All it takes is one weird improver from the group of six to raise huge questions.
 
I think it's important for the placebo data to look like placebo data. All it takes is one weird improver from the group of six to raise huge questions.
Agree completely. In complete Diesel Theory, isolating the Severe Phase 1B to a homogeneous group with established hearing loss, should minimize the placebo effect.
 
Same... If only we were billionaires.
Let's hope that research into long-term COVID-19 symptoms will accelerate research into tinnitus treatments. We as a community of tinnitus sufferers might not be billionaires, but the biotech companies addressing the issue certainly will be if they get their products out there soon enough to capture the wave of new people with tinnitus. This may be a COVID-19-blessing-in-disguise, i.e. hearing issues appear to be a potential outcome of covid infection, so it seems very likely that there will be a faster pace of research and development of treatments relevant to our community than there was before the pandemic:

"...7.6% of COVID patients experienced hearing loss, while 14.8% of them experienced tinnitus. A further 7.2% experienced vertigo, a loss of balance which occurs in people with ear damage...

...Though caution needs to be taken, we hope this study will add to the weight of scientific evidence that there is a strong association between Covid-19 and hearing problems."
- Scientists reveal that tinnitus is possible COVID-19 symptom

An estimated 141 million people have been infected with COVID-19 to-date. The 14.8% of them who may have tinnitus as a long-term symptom = 20,868,000 new tinnitus patients since the beginning of the pandemic. And the pandemic is of course far from over. Any Frequency Therapeutics-type company looking at these numbers should be scrambling faster than ever to get their products right.
 
Frequency Therapeutics just tweeted a short age-related video.

Combine that and the AARP video a few weeks ago, and I hope they have good age-related results (which are imminent). They seem to at least want to highlight age-related loss.

They should have the data by now at least.
I found this interesting as well. If I recall correctly... the ARHL Phase 1B went to active/not-recruiting mid-December, so you would think that now, 120 days out, they've got some data to look at.
 
Let's hope that research into long-term COVID-19 symptoms will accelerate research into tinnitus treatments. We as a community of tinnitus sufferers might not be billionaires, but the biotech companies addressing the issue certainly will be if they get their products out there soon enough to capture the wave of new people with tinnitus. This may be a COVID-19-blessing-in-disguise, i.e. hearing issues appear to be a potential outcome of covid infection, so it seems very likely that there will be a faster pace of research and development of treatments relevant to our community than there was before the pandemic:

"...7.6% of COVID patients experienced hearing loss, while 14.8% of them experienced tinnitus. A further 7.2% experienced vertigo, a loss of balance which occurs in people with ear damage...

...Though caution needs to be taken, we hope this study will add to the weight of scientific evidence that there is a strong association between Covid-19 and hearing problems."
- Scientists reveal that tinnitus is possible COVID-19 symptom

An estimated 141 million people have been infected with COVID-19 to-date. The 14.8% of them who may have tinnitus as a long-term symptom = 20,868,000 new tinnitus patients since the beginning of the pandemic. And the pandemic is of course far from over. Any Frequency Therapeutics-type company looking at these numbers should be scrambling faster than ever to get their products right.
I believe they were referring to hospitalized patients so that number would be much smaller. It still highlights the issue, though.
 
Frequency Therapeutics just tweeted a short age-related video.

Combine that and the AARP video a few weeks ago, and I hope they have good age-related results (which are imminent). They seem to at least want to highlight age-related loss.

They should have the data by now at least.
I would advise not to read too much into their tweets because they are most likely unrelated to clinical trial results.

Just my opinion, though.
 
I would advise not to read too much into their tweets because they are most likely unrelated to clinical trial results.

Just my opinion, though.
I don't disagree but thought it was an interesting switch of focus even if usually meaningless.

Jeff Karp also liked the recent age-related tweet (I haven't noticed him doing that before) and he's been hands off before, as well as Decibel Therapeutics' CEO, which is unusual, but I fully agree that it can be read *way* too much into.
 
If it worked, the guy that got 4 FX-322 injections should have gotten some benefit from the drug and it would have showed up in his audiograms and word scores. Or the guy that got 3 FX-322 injections and then the placebo injection last. Or the guy that got a placebo injection and then 3 FX-322 injections... or the guy that got 3 placebo injections and then 1 FX-322 injection at the end.

There is something else going on that they are not understanding. You can't just blame the trial procedure entirely.
Sure, there can be something more going on but you can't say the drug doesn't work.

However, you can say that the dosing regimen they used in the trial did not work. We have 2 other studies that show it does work in single dose regimen.

The cochlea is a delicate and complex chemical messaging system that uses chemical messengers to translate sound waves to noises in your brain, so why is it hard to believe that dosing the ear up for 4 weeks straight with either placebo or more drug can interfere with its healing process that they tried to kick start on week 1. That is what I believe is going on.
 
Sure, there can be something more going on but you can't say the drug doesn't work.

However, you can say that the dosing regimen they used in the trial did not work. We have 2 other studies that show it does work in single dose regimen.

The cochlea is a delicate and complex chemical messaging system that uses chemical messengers to translate sound waves to noises in your brain, so why is it hard to believe that dosing the ear up for 4 weeks straight with either placebo or more drug can interfere with its healing process that they tried to kick start on week 1. That is what I believe is going on.
I should have clarified what I meant by "it doesn't work" and probably should not have used that wording.

In a post after that I outlined what we can hope to expect from a single dosing regimen.

As I have mentioned previously people were "hoping" and "expecting" better results than we got in the other studies.

I agree the cochlea is a delicate and complex system.
 
When should they announce the results?
It wouldn't surprise me if they wait until they comment on the Phase 2A results (assuming they do). Assuming the ARHL Phase 1B looks like the other Phase 1s, they can cushion a second fallout from whatever confusion comes from the Phase 2A full readout.
 
I'm going on over 2 years now with tinnitus. I haven't checked this thread in a good 8 months. Sorry for being negative, but let me guess... there is still absolutely nothing I can do about my tinnitus? Phase 2 trials were a hit or miss, FX-322 out by 2050 maybe?

There's a fine line between tragedy and comedy.
 
If you have almost perfect hearing with a slight loss of 0 dB to 10 dB at 8 kHz -> FX-322 might help

If you are able to hear, but have decreased word scores -> FX-322 might help

If you have hearing loss from 8 kHz to 16 kHz -> FX-322 might help

If you have super high frequency tinnitus from 8 kHz to 16 kHz -> FX-322 might help

Is there anything more we can hope for at this point?
And what about the T and the lost frequencies between 16 kHz and 20 kHz? I am only 26 and lost most of it in an acustic trauma 4 months ago. I wonder why I had this good hearing until now but it feels so wrong now.
 
Just got this from my USPTO Alerts. Looks like they're thinking about more product names for "FX-322." These all fall under the appropriate category for a drug trademark:

ECOUSTIQ: https://tsdr.uspto.gov/#caseNumber=...TION&caseType=DEFAULT&searchType=statusSearch

JENFONIQ: https://tsdr.uspto.gov/#caseNumber=...TION&caseType=DEFAULT&searchType=statusSearch

ACUFONIQ: https://tsdr.uspto.gov/#caseNumber=...TION&caseType=DEFAULT&searchType=statusSearch

Previously, they applied for "RADIAL" - Which appeared to be a trademark for a hearing loss assessment/diagnostic: https://tmsearch.uspto.gov/bin/showfield?f=doc&state=4802:x2zghm.4.17
 
Just got this from my USPTO Alerts. Looks like they're thinking about more product names for "FX-322." These all fall under the appropriate category for a drug trademark:

ECOUSTIQ: https://tsdr.uspto.gov/#caseNumber=...TION&caseType=DEFAULT&searchType=statusSearch

JENFONIQ: https://tsdr.uspto.gov/#caseNumber=...TION&caseType=DEFAULT&searchType=statusSearch

ACUFONIQ: https://tsdr.uspto.gov/#caseNumber=...TION&caseType=DEFAULT&searchType=statusSearch

Previously, they applied for "RADIAL" - Which appeared to be a trademark for a hearing loss assessment/diagnostic: https://tmsearch.uspto.gov/bin/showfield?f=doc&state=4802:x2zghm.4.17
Good news, right? They are doing this after getting age-related hearing loss data.

I liked FX-322 though :(
 
I'm going on over 2 years now with tinnitus. I haven't checked this thread in a good 8 months. Sorry for being negative, but let me guess... there is still absolutely nothing I can do about my tinnitus? Phase 2 trials were a hit or miss, FX-322 out by 2050 maybe?

There's a fine line between tragedy and comedy.
Sorry to hear about your tinnitus and how long you have suffered at its malicious hands.

Reading some of these threads that have been started years ago, I must say I feel the same, resolve doesn't seem in sight. All I see is people putting a lot of emotional stock, time and time again, into valiant efforts that ultimately fail.

Even if a treatment is shown effective in the future, it doesn't mean we're all going to benefit either. It's hard reading some posts on here, seeing "when is this Phase over?," "need to release to market fast" etc because I'm not sure they fully understand it may or may not work.

I'm to the point in believing if you're middle aged or above, a treatment for tinnitus isn't likely something you'll see in your lifetime... unless you're lucky enough to make it to a very old age.

So I'll contradict my entire post by saying come on FX-322 and OTO-313!!
 
Good news, right? They are doing this after getting age-related hearing loss data.

I liked FX-322 though :(
It's hard to say with trademarks and patents. It shows they're still focused on getting it to product, and know they need a name that is marketable to doctors and patients that is memorable. Filing for trademarks isn't really all that expensive in the grand scheme of things, but it's likely there's other marketing work going on alongside this filing that is (think commercials, print advertisements, website updates, other creative work).

Right now, they probably want to at least be prepared to start the marketing effort early if results start looking favorable.
 
Just got this from my USPTO Alerts. Looks like they're thinking about more product names for "FX-322." These all fall under the appropriate category for a drug trademark:

ECOUSTIQ: https://tsdr.uspto.gov/#caseNumber=...TION&caseType=DEFAULT&searchType=statusSearch

JENFONIQ: https://tsdr.uspto.gov/#caseNumber=...TION&caseType=DEFAULT&searchType=statusSearch

ACUFONIQ: https://tsdr.uspto.gov/#caseNumber=...TION&caseType=DEFAULT&searchType=statusSearch

Previously, they applied for "RADIAL" - Which appeared to be a trademark for a hearing loss assessment/diagnostic: https://tmsearch.uspto.gov/bin/showfield?f=doc&state=4802:x2zghm.4.17
Would this be a sign that the age-related and severe hearing loss trials have a positive outcome?
 
Just got this from my USPTO Alerts. Looks like they're thinking about more product names for "FX-322." These all fall under the appropriate category for a drug trademark:

ECOUSTIQ: https://tsdr.uspto.gov/#caseNumber=...TION&caseType=DEFAULT&searchType=statusSearch

JENFONIQ: https://tsdr.uspto.gov/#caseNumber=...TION&caseType=DEFAULT&searchType=statusSearch

ACUFONIQ: https://tsdr.uspto.gov/#caseNumber=...TION&caseType=DEFAULT&searchType=statusSearch

Previously, they applied for "RADIAL" - Which appeared to be a trademark for a hearing loss assessment/diagnostic: https://tmsearch.uspto.gov/bin/showfield?f=doc&state=4802:x2zghm.4.17
Imagine getting paid to come up with "Jenfoniq".
 
Would this be a sign that the age-related and severe hearing loss trials have a positive outcome?
TBH, it probably doesn't mean much in relation to the trials. Think of it like getting a reservation for a name they might use.
 

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