Otonomy OTO-313 — Treatment of Tinnitus

If you can wait until @ChrisBoyMonkey goes back in to check whether he got the real drug or placebo. If he got placebo you should definitely do the trial.

 

Looks like the stock price jumped 60% between late December and now. They have several drugs in the pipeline so I'm not sure what would have been behind the sudden interest. Only thing I can see that triggered this was an analyst set them to "outperform" back on December 23rd.

 

From today

https://www.globenewswire.com/news-...es-Corporate-and-Product-Pipeline-Update.html

 

@Autumnly hope you’re ok?

Quick question, how’s OTO-313 progressing? I know there’s a trial but do we have any initial insights?

 

A Phase 1/2 trial, evaluating safety and exploratory efficacy measures of OTO-313 is underway, with results expected in the second quarter of 2020.

Actual Study Start Date: April 4, 2019
Estimated Primary Completion Date: May 2020

OTO-313: Enrollment in Phase 1/2 Clinical Trial in Tinnitus is Ongoing with Results Expected in the Second Quarter of 2020. Otonomy has successfully completed the initial safety cohort of this randomized, double-blind, placebo-controlled trial, and is enrolling approximately 50 patients with persistent tinnitus in the exploratory efficacy study cohort. OTO-313 is a sustained-exposure formulation of the potent and selective NMDA receptor antagonist gacyclidine. source

 

Article from 9 Jan providing updates on Otonomy!

https://www.globenewswire.com/news-...es-Corporate-and-Product-Pipeline-Update.html

 

Thank you @Autumnly! At the moment they are awaiting results on safety / say May 2020. When will they start testing for efficacy?

 

Thank you @serendipity1996... Does anyone have any hopes for this product?

 

I’m quite wary of this product for chronic tinnitus once I read about the history of AM-101 and learned more about the mechanism of action...I think it could help in the acute phases but as we saw with Chris once you’re out of the “acute window” you run the risk of altering your GABA in a detrimental way that could lead to worsening.

I would not get this myself personally. Possibly if I had a spike but I think we might have the Hough Pill by then to pop if need be.

 

I am not very hopeful, you can read the paper that lead to the development of the drug here:

https://www.tinnitustalk.com/threads/otonomy-oto-313-—-treatment-of-tinnitus.26092/#post-407832

Re-reading it now, it just doesn't seem that promising.

However, OTO-413 looks very interesting, and we should hear results back about that the same time the results for OTO-313 are in. Otonomy also seems to have a lot of stuff in the pipeline:

https://www.otonomy.com/pipeline/

I'm optimistic that sometime within the next 5 years we'll have something that will cure or partially cure tinnitus.

 

OTO-6xx is also the only one i see that will address "severe hearing loss." I'm extremely curious about what's different about their approach to tackle severe cases.

 

Thanks, I have no detectable hearing loss... so that was the only viable option...

 

Thanks for the link. I just read it and I guess I came to a different conclusion. It looks promising just very early and undeveloped. It will obviously be interesting to see results from a clinical trial

 

... I bet they'll just recycle some gamma-secretase inhibitor, nothing new. But if they eventually come up with a new idea, well, that'd be great.

 

Otonomy Announces Multiple Presentations at Association for Research in Otolaryngology Annual Meeting

They have a few presentations during this event:

Joint presentation with AGTC related to the GJB2 gene therapy program:

• "Ex vivo assessment of AAV capsid variant tropism and safety in rat cochlea" by Uribe et al., on January 27.

Presentations related to Otonomy’s OTO-510 program for CIHL:

• "Ex vivo evaluation of the therapeutic potential of several drug classes to prevent cisplatin mediated ototoxicity in the rat cochlea” by Mathur et al., on January 26.
• "Evaluations of various therapeutic classes in protection against cisplatin-induced hearing loss (preclinical models)" by Tsivkovskaia et al., on January 26.

Presentations related to Otonomy's other clinical and preclinical hearing loss programs:

• "Characterization of OTO-413, an intratympanic sustained-exposure formulation of the neurotrophic factor BDNF, in preclinical models of cochlear synaptopathy" by Tsivkovskaia et al., on January 26.
• "Comparisons of single versus combinatorial strategies for hair cell regeneration in cochlear explants" by Uribe et al., on January 27.

Joint presentation of data with research collaborators at the University of Washington related to preclinical evaluations of an age-related hearing loss model:

• "Age-related hearing loss in zebrafish: surprising senescence in an animal with continuous hair cell turnover" by Coffin et al., on January 28.

Nothing on the current clinical trials, that's to be expected but a few things to look for nonetheless.

 

For anyone that is considering applying to the OTO-313 trial, the doctor that performs the injection can find out whether the participant got the placebo or the actual medicine, if the participant were to have an adverse event or tinnitus gets worse. Does anyone have any experience or knowledge of Gacyclidine, the paper that I read cited perfusion of 43-60 hours, so I am guessing a single shot may be relatively temporary. It appears this drug is used in the treatment of head trauma, and some other neuro treatments...

Outside of the normal risks of needle to the ear, does anyone have an opinion on why trying this drug could be bad news for future treatments?

Sidebar: I read an article advising ER docs to watch for Gacyclidine as a drug of abuse or ingredient in street drugs...

 

One component of OTO-313 is its "sustained exposure formulation" which was not part of the earlier study and presumably responds to the need for a practical continuous exposure delivery mechanism.

 

Should be completed now... I wonder when they're going to report their results.

 

A New CURE For Tinnitus? | OTO-313

An Audiologist on OTO-313.

(Warning, he suggests TRT at the end. )

 

At 3:04 (in the video) the audiologist begins to dissect the second difference between the Wenzel study and the clinical trial related to OTO-313. He seems concerned that a "single injection" (of OTO-313) would be insufficient to deliver a high-enough dose of Gacyclidine (and thereby he pretty much demonstrates that he is unaware of Otonomy's sustained delivery concept – which actually permeates the entire pipeline of the company). A single injection of the polymer containing OTO-313 is enough to provide about a month's worth of exposure (something I commented on here).

It is true that high doses of Gacyclidine were delivered – under ideal conditions – directly into the cochlea of the six study participants in the Wenzel study. But the investigation failed to deliver significant results probably because the enrolled patients were chosen on a compassionate basis (and hence they were not ideal subjects since they had exhausted all other options and were already at the chronic tinnitus stage by the time they got treated).

Disclaimer: I read the Wenzel study several times in the past (which is now +2 years ago) – so the above is stretching my memory a bit...

 

https://www.globenewswire.com/news-...ogram-Update-Conference-Call-and-Webcast.html

Otonomy are hosting a conference call on June 15 to discuss their three ongoing clinical trials.

 

Otonomy will also be presenting at the Raymond James 2020 Human Health Innovation Conference on June 18.

https://finance.yahoo.com/news/otonomy-present-raymond-james-2020-113010097.html

 

Updates from today:
https://finance.yahoo.com/news/otonomy-provides-clinical-trials-development-200510830.html
They're currently hosting a conference call and webcast discussing these updates.

• Results from Phase 3 trial of OTIVIDEX® in Ménière’s disease expected in first quarter of 2021
• Results from Phase 1/2 trial of OTO-313 in tinnitus expected in July 2020
• Results from Phase 1/2 trial of OTO-413 in hearing loss expected in fourth quarter of 2020
• Current capital funds operations through all clinical trial readouts

 

Is OTO-313 for acute tinnitus only? If it is, I'm sickened.

 

Excuse my constantly spamming this thread yet again! Otonomy have uploaded their June 2020 (15th June) Corporate Presentation.
https://investors.otonomy.com/static-files/01101f4e-d2d9-4104-91cc-af03ac7221fd
Good overview of where they're at.

 

Could someone please explain me in an simple way what is the difference between OTO-313 and FX-322?

And why are there only 10 pages in this thread (if OTO-313 is supposed to cure tinnitus) whereas FX-322 thread counts more than 150 pages?

 

You are not really spamming, it's good info! So thanks a lot

 

Can someone summarize what we know about OTO-6XX?

 

OTO-313 is for acute tinnitus only. That doesn't apply for most of us.

 

Yes, there is a time window in which it can be used and I believe one of the goals of the trial was to figure out what that was.