Frequency Therapeutics — Hearing Loss Regeneration

#19,714
Nick47 said:
@Nobody19, do you think Otonomy will push on? I think the company is done.
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On the way out they could at the very least share their findings with other companies, of course for a nice price as I'm sure the people who did all the financial backings would like compensation of some sorts.

Such a shame too, because I always thought Otonomy > Frequency Therapeutics...

But hey they have discovered more about the inner ears/auditory system so hopefully they can utilize that and retry.
 
#19,715
KoolKat said:
Such a shame too, because I always thought Otonomy > Frequency Therapeutics...
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@KoolKat, I liked Otonomy as they seemed to 'get on with it' and always delivered the results bang on time. In contrast to Frequency therapeutics who seem stuck in Phase 2 forever, failing, making excuses, then scraping through, re-running, failing etc.
 
#19,716
KoolKat said:
On the way out they could at the very least share their findings with other companies...
But hey they have discovered more about the inner ears/auditory system so hopefully they can utilize that and retry.
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This is an important point. It is just as crucial that Otonomy report what didn't work in their research findings as well as what has the potential to.

It would be a travesty if another company (possibly Frequency Therapeutics?) researched a similar treatment from square one without the knowledge of Otonomy's "mistakes".

Progression made from others' attempts is just as good a way to succeed as any.
 
#19,717
Nick47 said:
@KoolKat, I liked Otonomy as they seemed to 'get on with it' and always delivered the results bang on time. In contrast to Frequency therapeutics who seem stuck in Phase 2 forever, failing, making excuses, then scraping through, re-running, failing etc.
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OTIC was founded in 2008 and has been plagued with failure after failure as evidenced by the fact that they haven't brought a single drug to market over the last 14 years.

Otividex, their Meniere's candidate, failed Phase 3... twice.

OTO-313, their tinnitus candidate, failed Phase 2.

OTO-413, their synaptic regeneration candidate, has failed in the high dose study.

Contrast this with FREQ which was founded in 2014; a whole 6 years after OTIC yet FREQ's lead clinical asset, FX-322, is in Phase 2b which is ahead of OTIC's now lead candidate, OTO-413, which is only in Phase 2a.

So how is OTIC "getting on with it" yet FREQ is failing, making excuses, then scraping through, re-running, failing etc?

You think FREQ is slow? Audion initiated a Phase 2 trial over a year ago for their cochlear hair cell regeneration candidate which got delayed a year and now has a primary completion date of 2024. So it will take them 3 years in total, a whole 2 years longer than FREQ's Phase 2b trial. FREQ is working at a pretty fast pace compared to many biotech companies out there.
 
#19,718
Chad Lawton said:
OTIC was founded in 2008 and has been plagued with failure after failure as evidenced by the fact that they haven't brought a single drug to market over the last 14 years.
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All of what you've said is very true. In their defense though, Otonomy did release Otiprio for swimmer's ear. They later sold it.
 
#19,719
Nobody19 said:
All of what you've said is very true. In their defense though, Otonomy did release Otiprio for swimmer's ear. They later sold it.
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That's fair, my mistake. I wasn't aware of that one as they make no mention of it on their pipeline. Most biotechs keep drugs listed on their pipeline after making it to market but it makes sense that they didn't since they sold it.
 
#19,721
CRGC said:
Hearing loss treatment moves forward despite early disappointment

Interesting news article on Frequency Therapeutics. Not much new information for those of us who have been following this thread, but a good introduction to the company's research as it stands nonetheless.
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Last as long as two years? The phrasing of that is odd, almost as if it isn't permanent.
In early clinical trials, a drug known as FX-322 produced significant improvement in speech perception in several participants with noise-induced hearing loss after a single injection into the inner ear -- with some reporting benefits that lasted as long as two years, according to its developer, Frequency Therapeutics of Lexington, Mass.
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#19,722
CRGC said:
Hearing loss treatment moves forward despite early disappointment

Interesting news article on Frequency Therapeutics. Not much new information for those of us who have been following this thread, but a good introduction to the company's research as it stands nonetheless.
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Good article and find!

I guess less is more in regards to dosage amounts/frequency with both FX-322 and OTO-413.

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Hope this comes to fruition next year, Phase 3 potential. Crossing my fingers. This looks to surely hit the market before (if ever) OTO-413 makes it. I guess we got to hope that our tinnitus is related to hearing cell damage vs. synaptopathy if that's the case.

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#19,723
From Frequency Therapeutics' tweet just now:

Join us Tuesday for our virtual investor event as we look to the Q1 readout of the Phase 2b study of FX-322, our lead candidate for hearing restoration. We will be joined by leading KOLs in the hearing field and provide an update on our pipeline.
Register: https://edge.media-server.com/mmc/p/mjg4swfz​

I might be working at the time. If anyone attends, please do let us know if there's any fresh news about the results of the current trial, and stuff.
 
#19,724
Artemis2K said:
Last as long as two years? The phrasing of that is odd, almost as if it isn't permanent.
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They word it that way because that is the farthest out they tested subjects. Another way to word it would be to say "the benefits from a single injection were still maintained 2 years later for some subjects."
 
#19,726
Gb3 said:
@Chad Lawton, what does Q1 readout mean? Are they going to reveal results?
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Q1 readout means the data will be shared sometime between January 1st 2023 and March 31st of 2023. The studies' primary completion date is January 6th which means that the last subject will have their 90 day test done on the January 6th. After that the company will compile the data and release it, I estimate that will take a few weeks for them to crunch the numbers so we likely won't see data until February at the earliest. The company is known for releasing things at the very end of their timelines so I wouldn't be surprised if it even happened in March potentially.
 
#19,731
Chad Lawton said:
Q1 readout means the data will be shared sometime between January 1st 2023 and March 31st of 2023. The studies' primary completion date is January 6th which means that the last subject will have their 90 day test done on the January 6th. After that the company will compile the data and release it, I estimate that will take a few weeks for them to crunch the numbers so we likely won't see data until February at the earliest. The company is known for releasing things at the very end of their timelines so I wouldn't be surprised if it even happened in March potentially.
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The way they worded it sounded like they were going to be releasing the results next week. I wonder if we get any new information about the current trial. I think it's highly unlikely which will mean we have to wait between January and end of March to find out.
 
#19,732
Lucifer said:
The way they worded it sounded like they were going to be releasing the results next week. I wonder if we get any new information about the current trial. I think it's highly unlikely which will mean we have to wait between January and end of March to find out.
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Agreed. Seems unlikely they will discuss the Phase 2b trial results next week as they still have at least 1 patient that needs to complete their 90 day test.
 
#19,733
Lucifer said:
I wonder if we get any new information about the current trial.
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No.
Chad Lawton said:
Agreed. Seems unlikely they will discuss the Phase 2b trial results next week as they still have at least 1 patient that needs to complete their 90 day test.
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They are not sharing the results. It's a looking ahead session, discussing the trial set-up and commercial opportunities according to the Frequency Therapeutics website.
 
#19,734
If it all works out, Phase 3 should take comparatively less time since there's no competing alternative on the market to compare to, right? Aren't there some cases where a Phase 3 could be skipped?
 
#19,736
#19,738
Serious question: If one of the drawbacks is the inability to access the lower frequencies through typical intratympanic injection procedures, what's the feasibility of compensating that through a programmable human-gyroscope set up? Basically guiding the serum into the desired spots by exploiting gravity. It would feel weird for a lot of people, but hopefully effective, and combining the technology could potentially only cost $10,000-$25,000, I would hope. If a robot isn't needed, then it would cost far less, if that's doable. It all depends on serum, I guess.
Nick47 said:
Multiple doses showed no benefit.
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But was it the multiple doses themselves, or the fact that they were done so closely together, potentially disrupting the regenerative process? That's what I've been wondering. If future doses cannot be done in the event of further damage, that would be very unfortunate.
 
#19,739
Artemis2K said:
But was it the multiple doses themselves, or the fact that they were done so closely together, potentially disrupting the regenerative process? That's what I've been wondering. If future doses cannot be done in the event of further damage, that would be very unfortunate.
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It's unknown. So just saying "multiple doses didn't work" is misleading. And FREQ hasn't bothered investigating timing of the dosing, or any other alternative routes. They have discussed "multiple single doses" in the past, which might hint that the redosing happens significantly apart, where the first dose has fully dissipated.
 
#19,740

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