Acousia Therapeutics GmbH has announced that they have successfully enrolled 50% of patients in their ongoing Phase 2 clinical trial, the PROHEAR Study. The study is evaluating the effectiveness of ACOU085 (INN: bimokalner) in preventing cisplatin-induced hearing loss in patients with testicular cancer undergoing chemotherapy.
Cisplatin is a commonly used drug in cancer treatment and has been credited with significantly improving the 5-year survival rate for testicular cancer patients. However, its use is often accompanied by severe side effects, including permanent hearing loss. Studies have shown that up to 80% of patients treated with cisplatin may experience clinically-relevant hearing loss.
The PROHEAR Study is a placebo-controlled, randomized, double-blind, split-body trial being conducted at 13 leading German ENT university clinics. Participants receive ACOU085 in one ear and a placebo in the other. The study is currently actively recruiting participants.
According to Professor Hubert Löwenheim, Chair of the Department of Otolaryngology – Head & Neck Surgery at Tuebingen University and Scientific Supervisor of the study, this enrollment milestone is a significant step in Acousia’s mission to provide a treatment for cisplatin-induced hearing loss. He emphasizes the importance of preventing this debilitating side effect for cancer patients, as studies have shown that all participants who have received a high dose of cisplatin in the study have developed ototoxicity.
The PROHEAR Study is on track to complete enrollment by the end of the second half of 2025. Interested individuals can find more information on clinicaltrials.gov.
ACOU085 (INN: bimokalner) is a first-in-class, small-molecule drug that is delivered using a standard transtympanic administration of a proprietary, slow-release gel formulation. It has been shown in preclinical models to effectively reduce cisplatin-induced hearing loss by targeting the KCNQ4-encoded Kv7.4 potassium channel in the outer hair cells of the inner ear.
For more information, please contact Tim Boelke, M.D. at boelke@acousia.com or visit www.acousia.com.
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