Auris presents positive safety data of inner ear tinnitus drug
Basel – Swiss Auris Medical AG has reported positive safety data for its investigational drug AM-101 for the treatment for acute inner ear tinnitus in an ongoing phase I/II clinical trial. All doses from 30 to 810 µg/mL, which were administered by intratympanic injection, were well-tolerated by the 24 patients suffering from persisting moderate to severe tinnitus following acute noise trauma or sudden deafness. Incidence of adverse events (AEs) was low and similar in the verum and placebo arms. They were considered either unrelated or unlikely related to the treatment. No serious adverse events (SAEs) or AEs leading to withdrawal occurred during the study. AM-101 and its primary metabolite could be found in plasma samples obtained in the first hours following treatment in small amounts only (< 0.3 ng/mL), which confirmed the favourable safety profile of intra-tympanic injection. This minimally invasive procedure allows for a highly site specific treatment with low doses and only minimal systemic exposure. Additionally, Auris reported data pointing to efficacy of the NMDA receptor blocker. Both the subjective tinnitus loudness as measured by a 10 point visual analogue scale and the minimum masking level (MML) decreased, with the verum group showing greater improvements than the placebo group. Auris suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following inner ear excitotoxicity.