Auris misses in Phase III hearing loss trial

Auris Medical Holding AG (NASDAQ:EARS) stock fell 49% Nov. 28 after the company said brimapitide (AM-111) missed the primary endpoint in the Phase III HEALOS trial.

Neither tested dose of intratympanic brimapitide gel significantly improved hearing as measured by mean change in pure tone average (PTA) at day 28 from baseline compared to placebo. Specifically, brimapitide led to a mean improvement in PTA of 38.4 dB at the 0.4 mg/mL dose (p=0.226) and 36.6 dB at the 0.8 mg/mL dose (p=0.448) vs. 33.4 dB for placebo. The study enrolled 256 patients suffering from severe to profound sudden deafness within 72 hours from onset...