Tübingen, Germany – Acousia Therapeutics GmbH, a clinical-stage biotechnology company, has announced the completion of patient enrollment in its Phase 2 PROHEAR clinical study. The study is focused on developing treatments for acute and chronic inner ear hearing loss.
The company’s proprietary drug candidate, ACOU085 (INN: Bimokalner), has shown promising results in multiple preclinical hearing loss models, including drug-induced ototoxicity. The completion of patient enrollment marks an important development milestone for the drug.
The PROHEAR Study is a double-blind, randomized, placebo-controlled, split-body, multicenter Phase 2 trial. It has enrolled young male patients with metastatic testicular cancer who are scheduled to receive cisplatin-based chemotherapy. While cisplatin is a highly effective chemotherapeutic agent, cumulative doses of ≥300 mg/m² lead to clinically meaningful, permanent hearing loss in the majority of patients.
Fifteen leading university hospitals in Germany are participating in this interdisciplinary study. Patients are randomized to receive either ACOU085 or placebo administered prior to each cisplatin cycle in a split-body trial design. A battery of audiometric tests is performed at baseline and at the end of each cisplatin cycle.
The primary objective of the PROHEAR Study is to assess whether Bimokalner can prevent ototoxic hearing loss induced by cisplatin. The study uses within-patient, placebo-controlled comparisons of functional hearing metrics and is designed to provide translational target validation for Acousia Therapeutics’ Kv7.4 activator programs and clinical proof of principle for Bimokalner in hearing loss patients.
“We are pleased to announce the completion of patient enrollment in our Phase 2 PROHEAR clinical study,” said Tim Boelke, M.D., CEO & CMO of Acousia Therapeutics. “ACOU085 has the potential to prevent the permanent inner ear damage frequently observed following cisplatin-based chemotherapy. We are grateful 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 the second or third quarter of 2026.”
Boelke and Jonas Dyhrfjeld-Johnsen, CSO & CDO, will be attending JPM Week in San Francisco from January 12-15, 2026. They welcome the opportunity to engage with investors and strategic partners during the Biotech Showcase (company presentation: Tuesday, January 13, 2:15 PM PT) and BIO Partnering @ JPM Week.
ACOU085 is a first-in-class, etiology-agnostic otoprotective small molecule delivered via standard transtympanic administration in a proprietary slow-release gel formulation. Cisplatin-induced hearing loss is a severe and permanent side effect resulting from irreversible damage to the cochlea’s outer hair cells (OHCs). ACOU085 modulates the biologically validated KCNQ4-encoded Kv7.4 potassium channel expressed in OHCs and has shown significant potential to reduce cisplatin-induced hearing loss and preserve OHC integrity in preclinical models.
For more information about Acousia Therapeutics and their drug candidate ACOU085, please contact Tim Boelke, M.D. at boelke@acousia.com or visit their website at www.acousia.com.