Hearing loss company Acousia Therapeutics to receive CTA for first-in-man clinical study of ACOU085

Acousia Therapeutics GmbH has been granted CTA (Clinical Trial Authorization) by the German BfArM (Federal Institute for Drugs and Medical Devices) for the first-in-man clinical trial of its proprietary investigational small molecule drug, ACOU085. The study will commence in January 2022, and will include patients with mild to moderate age-related hearing loss.

“This marks an important milestone along our visionary roadmap to enable drug-based treatment of different forms of hearing loss,” said Chief Executive Officer Tim Bölke.

Professor Hubert Löwenheim, Chair of the Department of Otolaryngology-Head & Neck Surgery of the University of Tübingen and Acousia Therapeutics co-founder added: “Hearing loss is the most prevalent sensory disorder, that negatively affects communication, social interaction, and quality of life. Hearing loss is the leading cause of disability in the elderly. Furthermore, hearing loss is increasingly recognized as the single most important risk factor for developing early dementia.”

“ACOU085 is under development as a first-line treatment for patients in need of immediate, high, local drug exposure to help preserve their hearing,” said Chief Development Officer Jonas Dyhrfjeld-Johnsen. “Based on a unique mechanism of action that modulates the activity of outer sensory hair cells, we will explore how feasible it is to measure acute target engagement while validating the expected strong safety profile of ACOU085.”

Acousia Therapeutics GmbH is developing a series of small molecule drug candidates for local and systemic treatment of different forms of hearing loss. While the start of the first ACOU085 clinical study in patients with age-related hearing loss is scheduled for January, 2022, next generation drug candidates are being thoroughly characterized in a range of both specialized and standard preclinical models and assays.

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.