Auris Medical Hosts Key Opinion Leader Event Focused on Phase 3 Program for Acute Inner Ear Tinnitus
June 14 2016 - 7:31AM
- 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
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."
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Contact: Cindy McGee, Head of Investor Relations
and Corporate Communications, +41 61 201 1350,
investors@aurismedical.com
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