ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced today that it is terminating a late-stage study to treat sudden sensorineural hearing loss (SSNHL) with its investigational drug, AM-111. The company had been evaluating the drug in two late-stage studies, Healos and Assent.
The data from Healos study found that AM-111 was not statistically significant in improving hearing in the overall patient population, failing the main goal of the study.
AM-111 Hearing Loss Drug Trials
The Phase 3, randomized, double-blind, placebo-controlled studies were evaluating two dose levels of AM-111, 0.4 mg and 0.8 mg, in patients with severe and profound sudden deafness (or SSNHL), compared with a placebo.
The ongoing Assent trial, which is similar to the Healos study, was considered to no longer be adequate for testing the drug and, therefore, would be terminated early. The company did note, however, that a post-hoc analysis found the smaller does of the AM-111 drug did show some improvement in patients with sudden hearing loss.
“The read-out from the HEALOS Phase 3 trial with AM-111 in acute inner ear hearing loss is a major milestone for Auris. Although the trial did not meet our expectations for the primary efficacy endpoint in the overall study population, we are very pleased to see the clinically and statistically significant treatment effect in the profound hearing loss subpopulation. Considering the high unmet medical need, we look forward to discussing with regulatory agencies the next steps on our path to bringing AM-111 to patients. On behalf of our team at Auris Medical, I would like to extend my sincere appreciation to the patients and investigators involved in this trial.” –Thomas Meyer, Founder, Chairman and CEO of Auris Medical
The announcement of the termination of the trial comes just over two months following rival Otonomy’s announcement that it was cutting staff and suspending further trials in 2017, after disappointing results from the company’s drug trial with OTIVIDEX for Meniere’s disease.
Data from the trial anticipated to be available in the second half of 2018.