Auris Medical Provides Update on Tinnitus Drug Development Strategy

Discussion in 'Research News' started by Tigo, Apr 26, 2019.

    1. Tigo

      Tigo Member

      Tinnitus Since:
      2 years
      Cause of Tinnitus:
      genetic hearing loss
      Auris Medical Provides Update on Tinnitus Drug Development Strategy

      April 25, 2019 at 9:00 AM EDT
      Hamilton, Bermuda, April 25, 2019 (GLOBE NEWSWIRE) -- Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today provided an update on its tinnitus drug development strategy. The Company intends to discuss and validate the protocol for a pivotal clinical trial with its late-stage investigational drug Keyzilen® (AM-101) with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) and to take the program forward through partnering or other types of non-dilutive funding.

      The Company has completed the design of a new Phase 2/3 trial for its late-stage Keyzilen® program. The trial shall, in two stages, reaffirm the compound’s efficacy in the treatment of acute tinnitus following traumatic cochlear injury and provide confirmatory efficacy data to support a filing for marketing authorization. It will incorporate learnings from the four late-stage trials, TACTT2, TACTT3, AMPACT1 and AMPACT2, notably with regard to the collection of patient reported outcomes and certain elements of study conduct. In addition, it will explore the use of a novel method for objective tinnitus diagnosis and measurement. The Company intends to discuss and validate the Phase 2/3 trial design with the FDA and EMA.

      The Company aims to implement the further development of Keyzilen® as well as its early-stage tinnitus programs with non-dilutive funding. Funding options which are under consideration include: strategic partnering, special purpose vehicle financing, grant funding or a combination thereof.

      “From the analysis of the large amounts of trial data and based on feedback from investigators as well as patients, we have gained a clear understanding of how to improve tinnitus measurement and trial conduct in a new pivotal study with Keyzilen®,” stated Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “In addition, we expect the use of novel objective tinnitus diagnostics and measures to enhance patient selection and support patient reported outcomes. Given the strong unmet medical need among tinnitus sufferers worldwide, the positive data obtained with Keyzilen® from non-clinical studies as well as two Phase 2 trials and the two AMPACT trials, we remain committed to bringing this first-in-class therapy to patients. We look forward to our discussions with the regulatory agencies and to providing further updates on this promising program.”
       
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    2. Clint Azzopardi
      Woot

      Clint Azzopardi Member

      Tinnitus Since:
      October 2018
      Cause of Tinnitus:
      Not sure, Gentamicin or allaergy or both !
      So in a nutshell are they revisiting AM-101?
       
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    3. Paulmanlike

      Paulmanlike Member Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      The trouble Auris Medical had was ‘proving’ it worked, nevertheless good luck to them!

      Won’t benefit the majority of Tinnitus Talk members though since most of us are beyond the acute stage!
       
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    4. annV
      Fine

      annV Member

      Tinnitus Since:
      2005
      Cause of Tinnitus:
      unknown - possibly hereditary
      Heh. Auris Medical is flogging a dead horse. Thomas Meyer does not seem to know when to give up! AM-101 will never be indicated for tinnitus relief. I will show my boobs to all if it gets FDA approved in the future.
       
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    5. Paulmanlike

      Paulmanlike Member Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      Not necessarily. The problem they had was proving that it worked, which is very difficult to do given the subjective nature of tinnitus. Their strategy would indicate that Keyzilen still has a chance to make it to market even though it is only for acute tinnitus.

      Most chronic members here hoping on this mechanism of action working should be looking into AM-102 and OTO-313 that may be indicated for chronic tinnitus. AM-101 being approved is a good start to the pathway for a cure.
       
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    6. JohnAdams
      Starving

      JohnAdams Member Benefactor Hall of Fame

      Location:
      here
      Tinnitus Since:
      it started.
      Cause of Tinnitus:
      hearing loss
      But, but, muh Keyzilen?
       
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