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Clinical Trial to Begin on New Drug to Treat Acute Peripheral Tinnitus – Hearing Review

  • By admin
  • December 14, 2016
  • Comments Off on Clinical Trial to Begin on New Drug to Treat Acute Peripheral Tinnitus – Hearing Review

Auris Medical today announced enrollment of the first patient into in the TACTT3 clinical trial – a phase 3 study designed to evaluate the efficacy, safety and tolerability of intratympanic injections of AM-101 in the treatment of acute peripheral tinnitus following traumatic cochlear injury or otitis media. 18, 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 top-line results from the Phase 3 TACTT2 trial with KeyzilenTM (AM-101) in acute inner ear tinnitus. 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. Data from the TACTT2 trial support the positive safety profile established in previous studies, and results from the second Phase 3 trial, TACTT3, are expected in the fourth quarter of 2016. The primary endpoints are the change in tinnitus loudness from baseline to Day 84 and the change in the Tinnitus Functional Index total score. While previous clinical trials with AM-101 had focused on acute tinnitus only, data from a Phase 2 trial suggested that AM-101 might be effective also beyond the three month acute stage. The evaluation was based on the primary efficacy variable of the trial, improvement in subjective tinnitus loudness, as well as on improvement in the Tinnitus Functional Index.

The TACTT3 trial, which is being conducted in Europe, has enrolled approximately 80% of the targeted 300 patients during the acute tinnitus stage (Stratum A) and approximately 90% of the targeted 330 patients during the post-acute tinnitus stage (Stratum B). The trial has enrolled more than 300 patients during the acute tinnitus stage (Stratum A) and approximately 330 patients during the postacute tinnitus stage (Stratum B). The trial’s primary safety endpoint, incidence of clinically meaningful hearing deterioration, was low with no statistically significant difference from the placebo group, supporting the safety profile of KeyzilenTM. Inner ear tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or inflammation. Mar-10-15 08:56AM, Auris Medical Announces Completion of Interim Analysis in Post-Acute Tinnitus Stratum of TACTT3 Trial with AM-101 at noodls -5.80. The second phase III 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). Label Extension to the TACTT3 Study.

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. 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. Inner ear tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or inflammation. Tinnitus of less than three months of duration is considered acute, while older tinnitus is considered chronic. GlobeNewswire – Thu Mar 19, 6:08AM CDT. 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.

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