Frequency Therapeutics — Hearing Loss Regeneration

It didn't. The higher dosage trials failed (and so did their tinnitus drug, OTO-313).

Otonomy Reports Positive Top-Line Results from Phase 2a Clinical Trial of OTO-413 in Patients with Hearing Loss

 

@Nobody19, do you think Otonomy will push on? I think the company is done.

 

Let's hope so!

 

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.

 

@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.

 

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.

 

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.

 

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.

 

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.

 

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.

 

Last as long as two years? The phrasing of that is odd, almost as if it isn't permanent.

 

Good article and find!

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

--------

--------

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.

--------

--------

 

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.

 

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.”

 

@Chad Lawton, what does Q1 readout mean? Are they going to reveal results?

 

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.

 

Forgive my ignorance, but will a person with a cochlear implant still be able to take advantage of this treatment? Or is their cochlea now compromised?

 

Weren’t they going to publish the results Q4 of 2022?

 

Previous guidance said they would publish the results in either Q4 of 2022 or Q1 of 2023.

 

Yes, they are compromised.

Reducing damage to the inner ear during cochlear implant surgery

 

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.

 

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.

 

No.

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.

 

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?

 

Frequency Therapeutics has uploaded their latest presentation slides to their website.

They can be found here:

https://investors.frequencytx.com/static-files/3f7523cd-4ffa-4068-b346-41b9ba8c5083

 

Those are some pretty good results. I'd like to see what the results would be if they did a treatment every three or four months, as opposed to the monthly or the single dose.

 

Multiple doses showed no benefit.

 

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.

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.

 

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.

 

Thank you for posting this. I've been so horribly depressed lately. I know this ultimately means nothing for the next decade, probably, but these posts are the only thing that I can be hopeful about in life.