Auris Medical (NASDAQ: EARS) shares rose 13% this morning on news of the reception of Fast Track designation for AM-111 in the treatment of acute sensorineural hearing loss (ASNHL) from the U.S. Food and Drug Administration (FDA). The company is currently evaluating AM-111 in two phase 3 clinical trials. The first is the HEALOS trial, which is being conducted in several European and Asian countries. Auris Medical expects to complete enrollment in the second quarter of 2017 and report top-line results from this trial in the third quarter of 2017. The second trial, ASSENT, is being conducted in the U.S., Canada and South Korea. The company expects to report top-line results from this trial in the second half of 2018. “We are very pleased to have received Fast Track designation for AM-111 from the FDA,” commented Thomas Meyer, Auris Medical’s founder, chairman and chief executive officer. “The designation recognizes that acute sensorineural hearing loss can be a serious condition with a significant impact on day-to-day functioning. It may develop into irreversible, chronic hearing loss with debilitating consequences, yet there is no therapy available for ASHNL that is approved or that has shown clear evidence of therapeutic benefits.”
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About Auris Medical
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology. The Company is focused on the Phase 3 development of treatments for acute inner ear hearing loss (AM-111) and for acute inner ear tinnitus (Keyzilen®; AM-101) by way of intratympanic administration with biocompatible gel formulations. In addition, Auris Medical is pursuing intranasal betahistine for Meniere’s disease and vestibular vertigo (AM-125) as well as early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol “EARS.” For more information, visit www.aurismedical.com.
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