- Company introduces KeyzilenTM as brand name for AM-101
- KeyzilenTM has potential to be first-ever approved therapy for tinnitus
- Live webcast of event begins today at 8 am EDT
ZUG, Switzerland, June 14, 2016 (GLOBE NEWSWIRE) -- Auris Medical Holding AG (NASDAQ:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, is hosting an event focused on the treatment of acute inner ear tinnitus and the AM-101 Phase 3 clinical development program. The meeting will feature a presentation by Hinrich Staecker, MD, PhD, who serves as a principal investigator in the Company's TACTT2 trial, as well as presentations by members of the Auris Medical leadership team.
"At today's event, we are reviewing the Phase 3 clinical development program for AM-101 and the product's potential to help patients suffering from acute inner ear tinnitus," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "As we approach the completion of our pivotal trials and prepare to execute on this significant market opportunity, we are pleased to introduce KeyzilenTM as the brand name for AM-101."
"Many of my tinnitus patients have difficulties concentrating, relaxing or sleeping well and are experiencing substantial emotional distress," added Hinrich Staecker, MD, PhD. "KeyzilenTM has the potential to be a first-in-class treatment that provides a clinically meaningful reduction in tinnitus loudness and burden for patients. The ENT community looks forward to the upcoming results from the TACTT2 trial."
The meeting will begin today at 8 am EDT. A live webcast is available through the Events and Presentations page in the Investors section of the Auris Medical website at www.aurismedical.com, and a replay of the presentation will be available following the event.
About Dr. Staecker
Hinrich Staecker, MD, PhD, completed medical school at the Albert Einstein College of Medicine with distinction in Otology Research. After completing his residency in otolaryngology at Montefiore Medical Center, Dr. Staecker went on to a fellowship in Otology and Neurotology at Harvard Medical School's Massachusetts Eye and Ear. He is dual board certified in Otolaryngology and Neurotology by the American Board of Otolaryngology. Currently, Dr. Staecker is the David and Mary Zamierowsky Professor at University of Kansas School of Medicine, a member of the Collegium Oto-Rhino-Laryngologica, a fellow of the Triological Society, and a member of the American Otological Society.
About the KeyzilenTM Phase 3 Clinical Development Program
KeyzilenTM is a NMDA receptor antagonist intended for the treatment of acute inner ear tinnitus. The Phase 3 clinical development program includes the TACTT2 and TACTT3 trials. The TACTT2 trial has enrolled more than 330 patients and is being conducted primarily in North America under a Special Protocol Assessment (SPA) with the US Food and Drug Administration. Top-line results from this trial are expected in August 2016. The TACTT3 trial is being conducted in Europe, and enrollment of approximately 630 patients (300 in the acute stage and 330 in the post-acute stage) is expected to be completed by the end of June 2016. Top-line results from this trial are expected in the fourth quarter of 2016.
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 currently focusing on the development of treatments for acute inner ear tinnitus (KeyzilenTM; AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of the parent company Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol "EARS."
This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or Auris Medical's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the timing and conduct of clinical trials of Auris Medical's product candidates, the clinical utility of Auris Medical's product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical's intellectual property position and Auris Medical's financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical's capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Auris Medical's Annual Report on Form 20-F and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.
Contact: Cindy McGee, Head of Investor Relations and Corporate Communications, +41 61 201 1350, email@example.com
Source:Auris Medical AG