Auris Medical Holding AG (NASDAQ:EARS) investors hit the panic button following the news that the hearing device maker is discontinuing development of AM-111 for sudden deafness, as the Phase III HEALOS trial did not meet the primary efficacy endpoint of a statistically significant improvement in hearing from baseline to Day 28 compared to placebo for either the AM-111 0.4 mg/mL or AM-111 0.8 mg/mL treatment groups.
Auris Medical shares reacted to the news, losing nearly half of their value.
A post-hoc analysis of the subpopulation with profound acute hearing loss (i.e. mean hearing threshold of 90 dB or higher; n=98) revealed a clinically relevant and statistically significant improvement in the AM-111 0.4 mg/mL treatment group. The improvement at Day 28 was 42.7 dB in the AM-111 0.4 mg/mL group vs. 26.8 dB in the placebo group (p=0.0176). In the AM-111 0.8 mg/mL group the improvement was 37.3 dB (p=0.126).
AM-111 was well tolerated in the HEALOS trial, and the primary safety endpoint was met. There was no significant difference in the occurrence of clinically relevant hearing deterioration between either of the active treated groups and the placebo group at Day 28.
Auris CEO Thomas Meyer commented, "The read-out from the HEALOS Phase 3 trial with AM-111 in acute inner ear hearing loss is a major milestone for Auris [...] Although the trial did not meet our expectations on the primary efficacy endpoint in the overall study population, we are very pleased to see the statistically and clinically significant treatment effects in the profound hearing loss subpopulation. Considering the high unmet medical need, we look forward to discussing the regulatory pathway for AM-111 with the regulatory agencies. In addition, we continue to focus on the development of Keyzilen® for acute inner ear tinnitus, with top-line Phase 3 results expected in early 2018, and AM-125 for vertigo, which is preparing for Phase 1."
Auris Medical engages in the research, development, and commercialization of pharmaceutical products for inner ear disorders. Its products portfolio targets to treat tinnitus, Menière's disease, and hearing loss.
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