Hearing loss company Acousia Therapeutics: first patient with age-related hearing loss treated with ACOU085

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.

Share this release

Share on facebook
Share on twitter
Share on linkedin
Share on xing
Share on email
Latest news

Tim Boelke, M.D.

About Acousia Therapeutics GmbH

Acousia Therapeutics GmbH is a privately held, clinical-stage biotech company based in Tübingen, Germany. The company is dedicated to the identification of small molecules for the effective prevention and treatment of different hearing loss etiologies. Acousia is focused on the development of proprietary drug candidates, which are designed to affect the sensory outer hair cells (OHC) in the cochlea of the inner ear. The unique dual mode of action of its small-molecule Kv7.4 activators combines acute functional OHC enhancement and sustained OHC protection and aims to both enhance and preserve a patient’s natural hearing. Acousia Therapeutics develops drugs for both local and systemic administration.