Auris Medical enrolls first patient in HEALOS study of AM-111

HEALOS will evaluate the efficacy, safety and tolerability of single dose intratympanic injections of AM-111 in the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL; a.k.a. "sudden deafness").

The trial will enroll 255 patients suffering from acute severe to profound hearing loss within 72 hours from ISSNHL onset. They will be randomized to receive either AM-111 at 0.4 mg/mL or 0.8 mg/mL or placebo.

Auris Medical benefited for the design of the HEALOS trial from multiple discussions with European and US regulatory agencies.

The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline to Day 28 at the average of the three most affected contiguous test frequencies. HEALOS will be conducted in several European and Asian countries, involving more than 70 sites.

It is the first of two pivotal trials in Auris Medical’s phase 3 clinical development program with AM-111. The second trial, ASSENT, is expected to start enrolment in North America in the first half of 2016.

Auris Medical chief medical officer Bettina. Stubinski said: "We are very excited to begin enrolling patients in HEALOS. "Sudden deafness can be a very frightening experience, especially when the hearing loss is severe or profound and accompanied by tinnitus, and chances for complete recovery are low.

"AM-111 has shown very promising results as an otoprotectant in acute hearing loss, and we expect HEALOS to be a major milestone on our way towards the development of the first specific therapeutic for this condition."

Results from HEALOS are expected for the second half of 2017.