Auris (EARS) Begins Phase III Study For Sudden Deafness

Auris Medical Holding AG (NASDAQ:EARS) announced the commencement of patient enrollment in a second pivotal phase III study (ASSENT) on its pipeline candidate AM-111 for the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL), which is also known as sudden deafness.

The randomized, double-blind, placebo-controlled study is being conducted to evaluate the efficacy, safety and tolerability of a single-dose intratympanic administration of AM-111 in patients suffering from severe-to-profound ISSNHL within 72 hours from onset.

We note that the first pivotal phase III study – HEALOS – on AM-111 is currently underway in several European and Asian countries. In addition, the company plans to conduct a phase II study (REACH) on the candidate for the treatment of surgery-induced hearing loss in the U.S.

We are encouraged by the company’s progress with AM-111. The candidate enjoys orphan drug status both in the U.S. and EU for the treatment of acute sensorineural hearing loss.

The company also has another candidate, Keyzilen, in a couple of phase III studies – TACTT2 and TACTT3 – for the treatment of acute inner ear tinnitus. While top-line data from TACTT2 are expected in Aug 2016, TACTT3 top-line results are expected in the fourth quarter of 2016.

We note that both acute inner ear tinnitus and hearing loss are conditions that represent significantly unmet medical need. Considering the lack of approved treatments targeting these conditions, both Keyzilen and AM-111 could become the first treatment to be approved for these indications, upon successful development and subsequent approval.

Auris is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) , Retrophin, Inc. (NASDAQ:RTRX) and Bristol-Myers Squibb Company (NYSE:BMY) . All three stocks sport a Zacks Rank #1 (Strong Buy).