Auris reaches midway point of HEALOS trial enrollment

Auris Medical Holding, a clinical-stage company committed to the development of therapeutics to meet medical needs in otolaryngology, has announced that its HEALOS Phase 3 AM-111 clinical trial has reached the midway point for enrollment.

The trial will focus on idiopathic sudden sensorineural hearing loss (ISSNHL), also called sudden deafness.

"We are pleased to continue making progress with the Phase 3 development of AM-111 as the first specific therapeutic for acute inner ear hearing loss," Auris Chairman and CEO Thomas Meyer said. "HEALOS has now enrolled more than 125 patients out of the target of 255 patients, and we expect to report top-line results in the second half of next year, in line with previous guidance."

The HEALOS trial will be assessing the safety, efficiency and patient tolerability of a single dose of AM-111 by intratympanic administration. The trial, which is double-blind, placebo-controlled and randomized, will be conducted across parts of Europe and Asia. The trial is seeking to enroll patients who have severe-to-profound ISSNHL within 72 hours from the onset of the condition. The patients who are enrolled in the study will randomly receive a 0.4 mg/mL dose of AM-111, a 0.8 dose or a placebo.