Auris Medical provides update on tinnitus drug development strategy
Auris Medical 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 with the FDA and European Medicines Agency, or 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.