- 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.