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:
      2005
      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

      serendipity1996 Member

      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

      Location:
      Germany
      Tinnitus Since:
      July/August 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

      serendipity1996 Member

      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:
      2005
      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:
      Unknown, viral?
      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:
      Something Wicked This Way Comes
      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.
       

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