Auris Medical Holding AG (NASDAQ:EARS)
Auris Medical Holding AG (NASDAQ:EARS) traded higher in Friday’s trading session after announcing the completion of patient enrollment in its Phase 3 Healos clinical trial of AM-111. The stock was up by 10.62% to end the week at $0.9279 a share.
The Swiss biopharmaceutical company is a leading developer of therapies for unmet medical needs in neurology. The company is currently working on Phase 3 development of novel treatments for acute inner ear hearing loss as well as acute inner ear tinnitus. In addition, the company is working on intranasal betahistine for Meniere’s disease.
AM-111 is a novel treatment for sudden sensor neural hearing loss and is Auris Medical Holding AG (NASDAQ:EARS)’s lead drug candidate. The biopharmaceutical company is currently evaluating the efficacy, safety, and tolerability of the drug in a double-blind placebo-controlled study. The trial is being conducted in a number of European and Asian countries where the company has enrolled patients suffering from profound ISSNHL within the preceding 72 hours.
HEALOS is the first of two pivotal trials that Auris Medical Holding AG (NASDAQ:EARS) has planned for AM-111 as part of the Phase 3 clinical development program. Trial results from the ongoing HEALOS trial should be out before the end of the year. The second Phase 3 ASSENT trial will target 300 patients in the U.S, Canada and South Korea, Results from the trials are slated for release in the second half of 2018.
“We are very pleased that our first Phase 3 clinical trial of AM-111 is now fully enrolled with 256 patients. AM-111 could become the first specific therapy for patients with acute inner ear hearing loss, a condition that can severely impact day-to-day functioning,” said Thomas Meyer Auris Chief Executive Officer.
AM-111 has already received a fast-track designation from the U.S. Food and Drug Administration setting it on course for an accelerated approval on top line Phase 3 trial results.
In addition to AM-111, Auris Medical is also working on keyzilen AM-101 a novel treatment for inner ear tinnitus. The company has already completed an AMPACT1 and AMPACT3 open level extension studies. Immediate study results have confirmed long-term safety of Keyzilen.
During the first quarter, Auris Medical Holding AG (NASDAQ:EARS) entered into an agreement with Otifex Therapeutics Pty Ltd for the purchase of assets related to intranasal betahistine. The company also confirmed plans to develop betahistine in a spray formulation for the treatment of Vertigo.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.