Otonomy OTO-313 — Treatment of Tinnitus

Discussion in 'Research News' started by Michael Larsen, Jan 9, 2018.

    1. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      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.
       
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    2. patorjk

      patorjk Member

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Several reasons
      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.
       
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    3. serendipity1996
      No Mood

      serendipity1996 Member Podcast Patron

      Tinnitus Since:
      2011
      Cause of Tinnitus:
      Unknown but suspect noise-induced
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    4. Candy

      Candy Member Benefactor Advocate

      Tinnitus Since:
      06/2016
      Cause of Tinnitus:
      Unidentified
      @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?
       
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    5. Autumnly
      Wishful

      Autumnly Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      2013
      Cause of Tinnitus:
      Noise-induced
      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
       
    6. serendipity1996
      No Mood

      serendipity1996 Member Podcast Patron

      Tinnitus Since:
      2011
      Cause of Tinnitus:
      Unknown but suspect noise-induced
    7. Candy

      Candy Member Benefactor Advocate

      Tinnitus Since:
      06/2016
      Cause of Tinnitus:
      Unidentified
      Thank you @Autumnly! At the moment they are awaiting results on safety / say May 2020. When will they start testing for efficacy?
       
    8. Candy

      Candy Member Benefactor Advocate

      Tinnitus Since:
      06/2016
      Cause of Tinnitus:
      Unidentified
    9. HootOwl

      HootOwl Member Podcast Patron Benefactor Advocate

      Location:
      California
      Tinnitus Since:
      2009
      Cause of Tinnitus:
      Explanation in About You
      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.
       
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    10. patorjk

      patorjk Member

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Several reasons
      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.
       
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    11. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      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.
       
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    12. Candy

      Candy Member Benefactor Advocate

      Tinnitus Since:
      06/2016
      Cause of Tinnitus:
      Unidentified
      Thanks, I have no detectable hearing loss... so that was the only viable option...
       
    13. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor

      Tinnitus Since:
      April 16 2019
      Cause of Tinnitus:
      trauma
      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
       
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    14. John Queen

      John Queen Member

      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Unknown
      ... 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.
       
    15. Nonomat
      Wishful

      Nonomat Member Benefactor

      Location:
      France
      Tinnitus Since:
      06/2019 (mild) - 11/2019 (intrusive)
      Cause of Tinnitus:
      Noise induced
      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.
       
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    16. WntRelief

      WntRelief Member

      Tinnitus Since:
      Thanksgiving
      Cause of Tinnitus:
      not sure
      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...
       
    17. Jack V

      Jack V Member Benefactor

      Tinnitus Since:
      1/2020
      Cause of Tinnitus:
      please stop editing my posts - thanks
      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.
       
    18. Paulmanlike

      Paulmanlike Member Podcast Patron Benefactor Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      Should be completed now... I wonder when they're going to report their results.
       
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    19. aot
      Bookworm

      aot Member Benefactor Hall of Fame

      Location:
      USA
      Tinnitus Since:
      2016. Worsened 11/2019.
      Cause of Tinnitus:
      Probably sound induced, worsened due to noise expouse + flu.
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    20. attheedgeofscience
      No Mood

      attheedgeofscience Member Podcast Patron Mighty Benefactor Hall of Fame

      Location:
      Denmark
      Tinnitus Since:
      Resolved since 2016
      Cause of Tinnitus:
      See information page
      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...
       
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    21. serendipity1996
      No Mood

      serendipity1996 Member Podcast Patron

      Tinnitus Since:
      2011
      Cause of Tinnitus:
      Unknown but suspect noise-induced
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    22. serendipity1996
      No Mood

      serendipity1996 Member Podcast Patron

      Tinnitus Since:
      2011
      Cause of Tinnitus:
      Unknown but suspect noise-induced
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    23. serendipity1996
      No Mood

      serendipity1996 Member Podcast Patron

      Tinnitus Since:
      2011
      Cause of Tinnitus:
      Unknown but suspect noise-induced
      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
       
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    24. LongWait

      LongWait Member

      Tinnitus Since:
      11/2017
      Cause of Tinnitus:
      Loud Concert
      Is OTO-313 for acute tinnitus only? If it is, I'm sickened.
       
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    25. serendipity1996
      No Mood

      serendipity1996 Member Podcast Patron

      Tinnitus Since:
      2011
      Cause of Tinnitus:
      Unknown but suspect noise-induced
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    26. Kam75

      Kam75 Member

      Location:
      FRANCE
      Tinnitus Since:
      26/02/2019
      Cause of Tinnitus:
      Noise induced trauma
      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?
       
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    27. BBakkers
      Not amused

      BBakkers Member Podcast Patron Benefactor

      Location:
      Netherlands
      Tinnitus Since:
      2011, Spike 2019, Spike 2020
      Cause of Tinnitus:
      1e Loud Music, 2e earwax irrigation, 3e padel tennis
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    28. Jim51042

      Jim51042 Member

      Tinnitus Since:
      3/28/16
      Cause of Tinnitus:
      Headphone use
      Can someone summarize what we know about OTO-6XX?
       
    29. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      OTO-313 is for acute tinnitus only. That doesn't apply for most of us.
       
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    30. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      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.
       

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