Otonomy OTO-313 — Treatment of Tinnitus

-- like FX-322 it is for hair cell regeneration.

-- their stained photo in the presentation shows both inner and outer hair cells regenerating (the inner hair cell row before and after is especially impressive).

-- it is targeting "severe" hearing loss, unlike FX-322, which will be labelled for up to moderately severe.

-- they haven't released yet how it works or what the compound is

-- they have only recently selected a "lead compound" which means they are further along pre-clinically than they were.

 

@FGG I have high frequency hearing loss that starts from 9Hz-10Hz and my hearing is very low from 11Hz-12Hz.
Under 8 Hz, my hearing is normal.

I do have "acute" tinnitus as you said, it is so acute that I can hear it everywhere, everytime (watching a movie, in the car, in the shower...).

Why did you say that "acute tinnitus" does not apply to most of us? I read plenty of posts here of people saying that they can hear their tinnitus everywhere like me.

So based on my profile, what should works best for me? FX-322 or OTO-313?

 

Acute doesnt describe the severity. Acute means recently acquired (~3 months)
Although there is no clear scientific definition of when tinnitus is acute and when it isnt anymore

 

Ah okay thanks, I didn't realize "acute" had another meaning.

 

If you have had tinnitus longer than 3-6 months (and even 6 months is questionable), I highly doubt OTO-313 would help.

FX-322 should help you.

 

We've talked about it here as for acute tinnitus only, and clinical trials cut off eligibility at 6 months, but I've heard elsewhere that OTO-313 is NOT intended just for acute tinnitus only.

Jury's still out...

 

Where did you hear elsewhere it was for chronic? As far as I have heard the company has never suggested it for anything but acute.

 

During one of Otonomy's investor presentations, they talked about the drug and the tinnitus "market", so one could speculate that it is for chronic cases as it would be a bit misleading for investors if they presented it otherwise. Acute and chronic are two pretty big number differences.

 

I don’t understand the acute vs chronic trial stuff. I would think if you could fix either it would work for both. Right now as we know there’s no cure for hearing loss, tinnitus, Meniere's, hyperacusis, all I can say to these companies is fix something, anything.

 

The webcast from the Raymond James 2020 Conference (18 June) is now available online. There's also a transcript (although watch out for errors like ENTs being transcribed as 'Indian teas' and intratympanic injections as 'interest in panic' injections.

https://investors.otonomy.com/event...s-2020-human-healthcare-innovation-conference

 

This just came in - Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-313 in Patients with Tinnitus https://investors.otonomy.com/news-...s-positive-top-line-results-phase-12-clinical

 

Wasn’t this the trial that @ChrisBoyMonkey got a worsening in his tinnitus from?

Maybe it turns out he got a placebo instead of the real drug.

It mentions Day 29 and Day 57 patients who got the real drug had improvements in their tinnitus.

This decade is definitely the decade where we will have cures for hyperacusis and tinnitus.

 

Thanks for sharing the update, @MadsWithT.

Better results than I expected, to be honest. This makes me even more excited for the OTO-413 results to be announced at the end of this year.

Though we’re not there yet, it seems we’re finally on the right track to alleviating the burden of this terrible condition. There seems to be light at the end of the tunnel.

 

"43% of OTO-313 patients were responders at both Day 29 and Day 57 compared to 13% of placebo patients"

Not bad. At that rate it's worth a try.

 

SOOO... Anybody know anyone on this forum that participated?

 

• A single intratympanic injection of OTO-313 was well-tolerated with lower incidence of adverse events than the placebo group.

I refer to this as it was @ChrisBoyMonkey who was part of the trial and had a worsening in his tinnitus as a result. As it looks there is a proportion of 'adverse' events from this...

It may be worth trying to get in touch with Otonomy (I tried a while back unsuccessfully) if they would be interested in an interview @Markku and @Hazel.

I believe this company is definitely worth keeping an eye on for their long line of candidates in ear disorders. It seems Frequency has a lot more momentum with their single FX-322 in the pipeline but I would definitely be interested in hearing about Otonomy.

A lot of unanswered questions remain about Otonomy...

 

@ChrisBoyMonkey

Hi @Diesel - This member was part of the trial and got worsening tinnitus from it...

Also, I've been reading a lot of your posts lately and I just want to thank you for good knowledge and input into the threads...

 

Stronger results than I expected. Even more excited now for the OTO-413 results at the end of this year, which I’ve always felt more confident about.

“Given these results, Otonomy intends to advance OTO-313 into full Phase 2 development which may include evaluation of a higher dose and/or retreatment with OTO-313.”

Let’s see what increased dosage does in Phase 2. While I believe hearing regeneration will yield the best results, this is still good news. There appears to finally be some light at the end of this very long tunnel.

 

@ChrisBoyMonkey but apparently he stated he got a worsening from this drug.

 

It's for acute (up to 6 months in this case) tinnitus only.

 

@ChrisBoyMonkey did. Not sure if he got drug or placebo but he did not have good results.

 

Correct me if I'm wrong, but I believe that @ChrisBoyMonkey did participate in the trials.

 

A more detailed report here - https://investors.otonomy.com/static-files/7422fbf3-e07b-4b71-a398-fb578ab858e1

 

With just one injection. This could bode well for tinnitus patients.

 

• Next steps for program:

o Complete analysis and submit for presentation at a future medical conference
o Consider higher dose and/or retreatment with OTO-313 (Day 30) to increase % of responders
o Design Phase 2 that considers expanded tinnitus population (e.g., bilateral patients; > 6 months)

Interesting. So in this trial they tested for acute cases and in the next they will include chronic cases.

 

Non-disclosure agreement does make it likely they will stay mum.

 

I don't think they'd be allowed to talk about it.

 

Yes, @ChrisBoyMonkey and he had a worsening immediately afterwards. It’s somewhere within this thread and you can look at his post on the Lenire user thread where he mentions it.

I was scheduled to participate at WVU, but canceled my appointment after his report.

 

Hough Ear Institute better hurry up and stop with the excuses.

 

They need to start the clinical trials now and not fuck around.