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Auris clarifies endpoint for Phase 2/3 study of Keyzilen for tinnitus; shares up 3%

Sep. 13, 2019 9:40 AM ETAltamira Therapeutics Ltd. (CYTO) StockCYTOBy: Douglas W. House, SA News Editor
  • Auris Medical Holding (EARS +3.4%) announces that the FDA and EMA are both on board with the use of the Tinnitus Functional Index (TFI) as the primary efficacy endpoint for its planned Phase 2/3 clinical trial evaluating Keyzilen (AM-101) in patients with the chronic ear-ringing condition.
  • The two regulators also agreed on less frequent collection of patient-reported tinnitus loudness compared to previous trials where daily ratings were difficult to gather. The FDA considers the improvement in tinnitus loudness as a co-primary endpoint while the EMA considers it a secondary endpoint.
  • The company says it plans to support the continued development of Keyzilen with non-dilutive funding. Options include strategic partnering, special purpose vehicle financing, grant funding or a combination thereof.

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