Auris Medical initiates ASSENT Phase III trial of AM 111 to treat sudden deafness.

Auris Medical Holding has initiated patient enrollment in the ASSENT Phase III clinical trial of AM-111 in idiopathic sudden sensorineural hearing loss, or ISSNHL, which is also known as sudden deafness. The ASSENT trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of single-dose intratympanic administration of AM-111. The trial is being conducted in the U.S., Canada and South Korea and is set to enroll approximately 300 patients who are suffering from severe to profound ISSNHL within 72 hours from onset. Patients will be randomized to receive AM-111 0.4 mg/mL, 0.8 mg/mL or placebo in a 1:1:1 ratio; oral corticosteroids will be given as background therapy. The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline to Day 91.

ASSENT is the second of two pivotal trials in Auris Medical's Phase III clinical development program for AM-111. The first trial, HEALOS, which is being conducted in several European and Asian countries, was initiated in November 2015 and is enrolling approximately 255 patients. In the Phase II clinical trial program, patients with severe to profound hearing loss who were treated with AM-111 0.4 mg/mL showed a statistically significant improvement in hearing threshold, speech discrimination and a higher rate of complete tinnitus remission compared with placebo.

ISSNHL, also known as sudden deafness, is a rapid loss of hearing that can occur over a few hours or over a period of three days. According to the American Speech-Language-Hearing Association (ASHA), the cause can be found in only 10%�15% of patients and the estimated annual incidence of ISSNHL is five to 20 cases per 100,000 people in the US. But Auris believes there are approximately 105,000 treatable ears in the US on an annual basis, which translates to a market opportunity of $600m. Sudden deafness accounts for the majority of this potential, followed by acute noise trauma and middle and inner ear surgery trauma.

Comment: Auris expects the first results from the HEALOS trial in the second half of 2017 and results from the ASSENT trial in the first half of 2018.