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.”
       
      • Like Like x 2
      • Informative Informative x 2
    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?
       
      • Good Question Good Question x 2
    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!
       
      • Agree Agree x 3
    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.
       
      • Funny Funny x 9
      • Hug Hug x 1
      • Winner Winner x 1
    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.
       
      • Like Like x 2
    6. JohnAdams
      Festive

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Sector Alpha
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      But, but, muh Keyzilen?
       
      • Funny Funny x 2
    7. Autumnly
      Wishful

      Autumnly Member Podcast Patron Benefactor Hall of Fame Advocate

      Location:
      Germany
      Tinnitus Since:
      July/August 2013
      Cause of Tinnitus:
      Noise induced
      Auris Medical Forms Scientific Advisory Board for Tinnitus Programs

      AMILTON, BERMUDA — Biopharmaceutical company Auris Medical Holdings has announced the formation of a Scientific Advisory Board (SAB) for its tinnitus research and development programs.

      “We are delighted to have several world-renowned tinnitus experts join Auris Medical as advisors as we are preparing to advance our various tinnitus projects through further clinical and pre-clinical development. There continues to be a strong unmet medical need amongst tinnitus sufferers worldwide, and we look forward to bringing novel therapeutics to patients. Thanks to the support from our new Scientific Advisory Board and the learnings from our late-stage trials with Keyzilen®, we feel that we are in a good position to take Keyzilen® as well as our early-stage projects forward.”

      –Thomas Meyer, Auris Medical Founder, Chairman and CEO


      The appointments to Auris Medical’s Tinnitus SAB include:
      • Wolfgang Arnold, Professor Emeritus, former Director of the Department of Otolaryngology, Head and Neck Surgery of the Technical University of Munich, Germany
      • David Baguley, PhD, MBA, Professor in Hearing Sciences, Faculty of Medicine & Health Sciences, University of Nottingham, UK
      • Richard Salvi, SUNY Distinguished Professor and Director for the Center for Hearing and Deafness at the University at Buffalo, NY
      • Hinrich Staecker, MD, PhD, Professor, Director Division Otology/Neurotology, University of Kansas, KS
      The Company aims to implement the further development of Keyzilen® as well as its early-stage tinnitus programs with non-dilutive funding.
       
      • Informative Informative x 4
    8. Autumnly
      Wishful

      Autumnly Member Podcast Patron Benefactor Hall of Fame Advocate

      Location:
      Germany
      Tinnitus Since:
      July/August 2013
      Cause of Tinnitus:
      Noise induced
      Auris Medical Receives FDA and EMA Guidance for Keyzilen® Late-Stage Clinical Development Program

      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 announced that it has obtained advice on the development plan and regulatory pathway for its investigational tinnitus treatment Keyzilen® (AM-101) from the U.S. Food and Drug Administration (“FDA”) and from the European Medicines Agency (“EMA”). The Company had reached out to the two agencies in order to discuss and validate the design of a new Phase 2/3 trial for the Keyzilen® program. The advice was provided in the context of a Type C meeting and a Scientific Advice procedure, respectively.

      In their feedback, both the FDA and EMA supported the use of the Tinnitus Functional Index (TFI) questionnaire as the primary efficacy outcome measure. The TFI captures the impact of tinnitus on the patient’s day-to-day functioning. Furthermore, the two agencies agreed on a less frequent collection of patient-reported tinnitus loudness than in the previous Keyzilen® trials, where daily ratings had turned out to be problematic. The FDA considers the improvement in tinnitus loudness as a co-primary efficacy endpoint, whereas the EMA endorsed it as a secondary efficacy endpoint. In addition, the two agencies endorsed the planned sample size for the trial and provided important guidance on the regulatory path forward.

      “We very much appreciate the objective feedback and guidance from the FDA and EMA on our Keyzilen® program”, commented Thomas Meyer, Auris Medical’s founder, chairman and CEO. “We are very pleased to be aligned with the FDA and EMA on the key design aspects for the planned Phase 2/3 trial and look forward to working with the agencies as we continue to develop Keyzilen® as a potential first-in-class treatment for acute inner ear tinnitus.”

      The planned Phase 2/3 trial shall, in two stages, reaffirm and confirm the efficacy of Keyzilen® in the treatment of acute tinnitus following traumatic cochlear injury. It will incorporate learnings from the previous 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, the trial will explore the use of a novel method for objective tinnitus diagnosis and measurement. The Company aims to further develop Keyzilen® with the aid of non-dilutive funding. The funding options which are currently under consideration include: strategic partnering, special purpose vehicle financing, grant funding or a combination thereof.

      About Keyzilen® / AM-101
      Keyzilen® is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompatible gel and delivered by intratympanic administration. Keyzilen® is in development for treatment of acute tinnitus following traumatic cochlear injury. Emerging evidence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following acute traumatic injury to the inner ear. Persistent overexpression of NMDA receptors may lead to pathologic excitation of auditory nerve fibers, which in the brain is perceived as tinnitus. The development of Keyzilen® is based on research conducted at the INSERM Institute for Neurosciences, and patents have been granted in more than 40 countries worldwide so far.
       
      • Informative Informative x 3
      • Helpful Helpful x 1

Share This Page

Loading...