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Auris Medical AG’s Tinnitus Drug Misses Main Goals in Study; Shares Sink

  • By admin
  • December 14, 2016
  • Comments Off on Auris Medical AG’s Tinnitus Drug Misses Main Goals in Study; Shares Sink

ZUG, Switzerland, Aug. 11.2%). (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced the enrollment of the first subjects in a Phase 1 clinical safety trial of OTO-311, a product candidate for the treatment of tinnitus. Patients will be randomized to receive AM-111 0.4 mg/mL, 0.8 mg/mL or placebo in a 1:1:1 ratio; oral corticosteroids will be given as background therapy. The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline to Day 91. Auris Medical reported disappointing top-line results from a Phase III study of Keyzilen (AM-101) for acute inner ear tinnitus. The first trial, HEALOS, which is being conducted in several European and Asian countries, was initiated in November 2015 and is enrolling approximately 255 patients.

Captain America 4? Iron Man 4? Does it not mean we have an astonishing $$$ figure for tinnitus treatment at the VA? At this time, there is no cure for tinnitus and there are no FDA-approved drugs for treating this debilitating condition. OTO-311 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. Acute inner ear hearing loss may be accompanied by other disorders of the inner ear such as dizziness or tinnitus, and if it develops into permanent hearing loss, it may have chronically debilitating consequences. • FDA clearance has been received for the OTO-311 Investigational New Drug Application (IND), and initiation of a Phase 1 clinical safety trial is expected to begin before the end of 2015.

The TACTT3 trial is being conducted in Europe, and enrollment of approximately 630 patients (300 in the acute stage and 330 in the post-acute stage) is expected to be completed by the end of June 2016.

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