Basel, Switzerland, March 10, 2014 – Auris Medical today announced enrollment of the first patient into the TACTT21 clinical trial. This phase 3 trial will evaluate the efficacy, safety and tolerability of intratympanic injections of AM-101 in the treatment of acute peripheral tinnitus following traumatic coch-lear injury or otitis media. TACTT2 will enroll 330 patients at more than 60 sites primarily in the United States and Canada. The initiation of the TACTT2 trial follows shortly after the start of TACTT3, its European counterpart. Both have been designed as pivotal double-blind, placebo-controlled trials and are part of Auris Medical’s phase 3 development program with AM-101. All participants completing one of the TACTT studies and continuing to meet certain criteria will be eligible to enter an open label safety study (AMPACT1, respectively AMPACT2)2 and receive up to three treatment cycles with AM-101 over up to nine months.
Thomas Meyer, Auris Medical’s founder and CEO, commented: “It is an exciting moment for the company to have both phase 3 trials underway. TACTT2 and TACTT3 are based on more than 10 years of research and development and represent the largest clinical trials ever conducted with an intratympanic treatment.” He added: “The phase 3 program will be an essential step in our quest for developing the first specific thera-peutic for acute peripheral tinnitus, a condition without any effective and safe treatment options. We ex-pect results from both TACTT2 and TACTT3 trials in late 2015.”
About acute peripheral tinnitus
Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various ear or other diseases. Peripheral (inner ear) tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or inflammation. It may be short and just transitory; how-ever, it may also become permanent. Tinnitus of less than three months of duration is considered acute, while older tinnitus is considered chronic. Peripheral tinnitus may be only a slight nuisance, but often it has a serious impact on the ability to sleep, relax, or concentrate, or it may lead to tiredness, irritation, nervousness, despair, frustration, or even depres-sion. As of today, there exists neither a universal standard of care for acute inner ear tinnitus, nor a truly proven, effective treatment method.
AM-101 is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompat-ible 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 exces-sive synaptic release of glutamate, the principal neurotransmitter in the auditory system. Cochlear excitotoxicity may be triggered by, for example, trauma (e.g. exposure to excessive noise),
neuroinflammation, disturbances in inner ear blood supply (anoxia/ischemia), 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 of Montpellier, France. The clinical development of AM-101 was initiated by Auris Medical in 2007 and comprises three clinical trials to date. In 2013, Auris Medical reached agreement with the US Food and Drug
Administration (FDA) under a Special Protocol Assessment (SPA) for its pivotal TACTT2 study. Patents have been granted in more than 30 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 peripheral 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 earlystage research and development projects. The Company was founded in 2003 and is headquartered in Basel, Switzerland.
Dr. Thomas Meyer, CEO, firstname.lastname@example.org
Gretchen Schweitzer, MacDougall Biomedical Communications, +49 172 861 8540