Top-line results from pivotal TACTT2 trial expected in August 2016
Basel, Switzerland, March 30, 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, today announced that the Company has completed patient enrollment in the TACTT2 Phase 3 clinical trial of AM-101 in acute inner ear tinnitus. Top-line results from the TACTT2 trial are expected in August 2016.
“Completing enrollment of the pivotal TACTT2 trial represents an important corporate milestone for Auris Medical,” commented Thomas Meyer, Auris Medical’s founder, Chairman and Chief Executive Officer. “AM-101 has the potential to be a first-in-class treatment for patients suffering from acute tinnitus and we look forward to the upcoming results from this trial.”
The TACTT2 trial, which is being conducted primarily in North America, is a pivotal, randomized, double-blind, placebo-controlled trial in acute inner ear tinnitus following traumatic cochlear injury or otitis media. More than 330 patients were randomized to receive either AM-101 0.87 mg/mL or placebo in a 3:2 ratio. The primary endpoints are the change in tinnitus loudness from baseline to Day 84 and the change in the Tinnitus Functional Index total score. The trial is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration.
The second Phase 3 clinical trial of AM-101, TACTT3, which is being conducted in Europe, will enroll approximately 300 patients during the acute tinnitus stage (Stratum A) and approximately 330 patients during the post-acute tinnitus stage (Stratum B). Auris Medical expects to complete enrollment of the TACTT3 trial in a few months.
In the Phase 2 clinical trial program, AM-101 was well tolerated and demonstrated statistically significant improvements in tinnitus loudness, annoyance and impact as well as sleep difficulties for the AM-101 0.81 mg/mL dose compared to placebo at Day 90.
About Acute Inner Ear Tinnitus
Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various ear or other diseases. Inner ear tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or inflammation. Tinnitus may be transitory; however, it may also become permanent. Tinnitus of less than three months of duration is considered acute, while older tinnitus is considered chronic. Inner ear tinnitus often has a serious impact on the ability to sleep, relax, or concentrate, and it may lead to tiredness, irritation, nervousness, despair, frustration, or even depression. As of today, neither a universal standard of care for acute inner ear tinnitus, nor a truly proven and effective treatment method is available.
About AM-101
AM-101 is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompatible gel for intratympanic injection. Emerging evidence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following inner ear excitotoxicity, which is characterized by excessive synaptic release of glutamate, the principal neurotransmitter in the auditory system. Cochlear excitotoxicity may be triggered by exposure to excessive noise, neuroinflammation, disturbances in inner ear blood supply, or the administration of certain ototoxic drugs. It has been proposed that the upregulation of NMDA receptors induced by cochlear excitotoxicity is responsible for aberrant excitation of auditory nerve fibers, which is perceived as tinnitus. The development of AM-101 is based on research conducted at the INSERM Institute for Neurosciences, and patents have been granted in more than 40 countries worldwide so far.
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 (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”.
