ACOU085, the lead candidate from Acousia Therapeutics, has been administered to the first patient with age-related hearing loss (presbycusis) in a Phase 1b clinical study in Germany. The pre-screening of patients matching the comprehensive in/exclusion criteria for the ongoing trial is almost complete. In addition to the principle objective of the study, testing the safety and tolerability of the drug candidate in humans for the first time, a wide array of subjective and objective hearing tests are being conducted to support the investigation of target engagement.
ACOU085 is a proprietary small-molecule, otoprotective drug candidate that modulates a well-defined molecular target preferentially expressed in the sensory cells of the inner ear, the so-called outer hair cells (OHC). ACOU085 is characterized by a unique dual mode of action: the molecule triggers the acute enhancement of hearing function and offers long-term preservation of the terminally differentiated OHCs. In December 2021, Acousia Therapeutics was granted a CTA by the German BfArM to initiate its first-in-human Phase 1b clinical trial of ACOU085.
“This next step of Acousia’s otoprotective drug candidate ACOU085 into studies on patients suffering from presbycusis marks an important milestone on our path towards making hearing loss a treatable disease,” says Dr. Tim Boelke, Chief Executive Officer and Chief Medical Officer of the company.
“I am extremely proud that our hypothesis-driven, scientific work is now moving into the clinical stage only 6 years after initiating a full-fledged de novo drug development program on a novel, highly innovative drug target,” adds Hubert Löwenheim, Professor and Chair of the Department of Otolaryngology-Head & Neck Surgery of the University of Tübingen and Acousia Therapeutics co-founder.