Hearing loss company Acousia Therapeutics GmbH announced the successful completion of its ACOU085 clinical Phase 1b study today, following the final visit of the last patient treated with the highest ACOU085 dose. ACOU085 is a proprietary small-molecule drug candidate under clinical development, with a particular focus on its use as an etiology-agnostic otoprotectant for patients with acute forms of sensorineural hearing loss.
“Completing Phase 1 with ACOU085 is another fundamental milestone towards our disruptive goal of making sensorineural hearing loss a druggable disease,” said Chief Executive Officer Tim Bölke.
The next step is a clinical Phase 2 study using ACOU085 to protect the inner ears of testicular cancer patients undergoing chemotherapy from cisplatin-induced ototoxicity. It will be initiated in early 2023. Cisplatin (CDDP, Platinol) is an effective and widely used anti-cancer drug with severe dose-limiting side effects, including ototoxicity, that lead to permanent, disabling hearing loss in many patients.
Professor Hubert Löwenheim, co-founder and Chair of the Department of Otolaryngology-Head & Neck Surgery of the University of Tübingen and Acousia Therapeutics, added: “With Phase 1 concluded, we are very encouraged by the favorable safety and tolerability profile of ACOU085. These promising data support the continued development of ACOU085 in patients with sensorineural hearing loss. Sensorineural hearing loss constitutes an enormous burden of disease with no drug treatments available at this time.”