Acousia Therapeutics GmbH, a German biotech company, announced on Tuesday, April 29, 2025, that it has successfully enrolled 50% of patients in its 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 chemotherapy drug that has been a cornerstone in modern oncology since its introduction in the late 1970s. It has significantly improved the 5-year survival rate for testicular cancer patients, increasing it from just 5% to 98%. However, its life-saving benefits are often overshadowed by severe side effects, with permanent, bilateral hearing loss being one of the most debilitating. 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 in which participants receive ACOU085, a Kv7.4 channel activator, in one ear and a placebo in the other ear. The study is being conducted at 13 leading German ENT university clinics and is still actively recruiting participants.
Professor Hubert Löwenheim, Chair of the Department of Otolaryngology – Head & Neck Surgery at Tuebingen University and Scientific Supervisor of the study, commented, “This marks a significant milestone on Acousia’s journey to offer a treatment for the prevention of permanent hearing loss caused by cisplatin. Preventing this often overlooked side effect is critical for cancer patients. Notably, all PROHEAR participants who have received ≥300 mg/m² of cisplatin to date have developed ototoxicity, a higher rate than reported in most previous studies.”
The PROHEAR Study is expected to complete enrollment by the end of the second half of 2025. More information about the study can be found on clinicaltrials.gov.
ACOU085 (INN: bimokalner) is a first-in-class, small-molecule, etiology-agnostic otoprotective drug-candidate that is administered using standard transtympanic administration of a proprietary, slow-release gel formulation. Ototoxic hearing loss, which is a typical, severe, and permanent side effect of cisplatin treatment, is caused by irreversible damage to the sensory cells in the inner ear, known as outer hair cells (OHCs). ACOU085 targets the KCNQ4-encoded Kv7.4 potassium channel of the OHCs and has shown significant potential in preserving outer hair cells from ototoxicity and reducing cisplatin-induced hearing loss in preclinical models.
Media Contact:
Tim Boelke, M.D.
boelke@acousia.com
www.acousia.com
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