The Phase 2 ProHear trial is evaluating ACOU085 (Bimokalner) for its efficacy in protecting hearing during chemotherapy.
Acousia Therapeutics GmbH announced it has completed patient enrollment for its Phase 2 ProHear clinical study. The study is evaluating ACOU085 (Bimokalner), a small molecule drug candidate, for the prevention of cisplatin-induced ototoxicity.
The ProHear Study is a double-blind, randomized, placebo-controlled, multicenter trial using a split-body design. It has enrolled young male patients with metastatic testicular cancer who are scheduled to undergo cisplatin-based chemotherapy. Cisplatin is an effective chemotherapeutic agent, but it can lead to permanent hearing loss in a majority of patients receiving cumulative doses of ≥300 mg/m². The study, which includes fifteen university hospitals in Germany, will administer either ACOU085 or a placebo to patients prior to each cisplatin cycle, with audiometric tests performed at baseline and after each cycle.
“This drug candidate has the potential to prevent the permanent inner ear damage frequently observed following cisplatin-based chemotherapy,” says Tim Boelke, MD, CEO and CMO of Acousia Therapeutics, in a release. “As we reach full enrollment in the PROHEAR Study, I want to express gratitude to all participating patients and clinical teams for their trust and commitment. The blinded preliminary results are promising, and we look forward to reviewing the full unblinded dataset in Q2-Q3 2026.”
ACOU085 is an otoprotective small molecule delivered via transtympanic administration in a proprietary slow-release gel formulation. The drug is designed to modulate the KCNQ4-encoded Kv7.4 potassium channel, which is expressed in the cochlea’s outer hair cells (OHCs). Cisplatin-induced hearing loss is caused by irreversible damage to these cells, and ACOU085 has shown potential to reduce this damage and preserve OHC integrity in preclinical models.
Company leadership will be attending JPM Week in San Francisco from January 12-15, 2026, to engage with investors and strategic partners.
