Auris Med On Track To Resume Enrollment Of Keyzilen Tinnitus Program Following Regulatory Feedback
TACTT3 Phase 3 trial to resume enrollment in early 2017 as previously announced
ZUG, Switzerland, Dec. 06, 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 confirmed that the TACTT3 Phase 3 trial with KeyzilenTM (AM-101) will resume enrollment in early 2017 as per previous guidance. This announcement follows receipt of key approvals from regulatory agencies and ethics committees in Europe on the recently submitted TACTT3 protocol amendment.
"We believe that the protocol amendment we are implementing improves TACTT3's probability of success, and we look forward to top-line results from this trial in early 2018," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "With Keyzilen's strong safety profile and positive data from several trials, we are working to realize the potential of what could become the first pharmacological treatment for patients who suffer from acute tinnitus of the inner ear."
As previously announced, the TACTT3 protocol was amended based on analysis of the TACTT2 Phase 3 trial outcomes. The amended protocol elevates the Tinnitus Functional Index score from a key secondary endpoint to an alternate primary efficacy endpoint, includes certain patient subgroups in confirmatory statistical testing and increases the trial size with the enrollment of an additional 120 patients.
As part of the Company's continued dialogue with the U.S. Food and Drug Administration (FDA), Auris Medical recently had two meetings related to the KeyzilenTM program. Through a Type C Meeting, the FDA confirmed that, as per standard practice, two positive confirmatory trials would be required to submit a New Drug Application (NDA); the Agency did not provide feedback on the TACTT3 protocol amendment because the trial is being conducted in Europe and is not under the Investigational New Drug Application. In a separate meeting with the FDA, alignment was achieved on key items of the KeyzilenTM Chemistry, Manufacturing, and Controls section for a future NDA.
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 KeyzilenTM (AM-101)
KeyzilenTM 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 acute injury to the inner ear, e.g. from exposure to excessive noise, infections, disturbances in inner ear blood supply, or the administration of certain ototoxic drugs. Persistent overexpression of NMDA receptors may lead to pathologic excitation of auditory nerve fibers, which in the brain is perceived as tinnitus. The development of KeyzilenTM 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 Phase 3 development of treatments for acute inner ear tinnitus (KeyzilenTM; AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic administration 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."
ZUG, Switzerland, Dec. 06, 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 confirmed that the TACTT3 Phase 3 trial with KeyzilenTM (AM-101) will resume enrollment in early 2017 as per previous guidance. This announcement follows receipt of key approvals from regulatory agencies and ethics committees in Europe on the recently submitted TACTT3 protocol amendment.
"We believe that the protocol amendment we are implementing improves TACTT3's probability of success, and we look forward to top-line results from this trial in early 2018," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "With Keyzilen's strong safety profile and positive data from several trials, we are working to realize the potential of what could become the first pharmacological treatment for patients who suffer from acute tinnitus of the inner ear."
As previously announced, the TACTT3 protocol was amended based on analysis of the TACTT2 Phase 3 trial outcomes. The amended protocol elevates the Tinnitus Functional Index score from a key secondary endpoint to an alternate primary efficacy endpoint, includes certain patient subgroups in confirmatory statistical testing and increases the trial size with the enrollment of an additional 120 patients.
As part of the Company's continued dialogue with the U.S. Food and Drug Administration (FDA), Auris Medical recently had two meetings related to the KeyzilenTM program. Through a Type C Meeting, the FDA confirmed that, as per standard practice, two positive confirmatory trials would be required to submit a New Drug Application (NDA); the Agency did not provide feedback on the TACTT3 protocol amendment because the trial is being conducted in Europe and is not under the Investigational New Drug Application. In a separate meeting with the FDA, alignment was achieved on key items of the KeyzilenTM Chemistry, Manufacturing, and Controls section for a future NDA.
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 KeyzilenTM (AM-101)
KeyzilenTM 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 acute injury to the inner ear, e.g. from exposure to excessive noise, infections, disturbances in inner ear blood supply, or the administration of certain ototoxic drugs. Persistent overexpression of NMDA receptors may lead to pathologic excitation of auditory nerve fibers, which in the brain is perceived as tinnitus. The development of KeyzilenTM 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 Phase 3 development of treatments for acute inner ear tinnitus (KeyzilenTM; AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic administration 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."