Acousia Therapeutics GmbH, a clinical-stage biotechnology company based in Germany, announced on Thursday that it has completed patient enrolment in its Phase 2 PROHEAR clinical study of ACOU085 (INN: Bimokalner).
Bimokalner is a proprietary, first-in-class small molecule that has demonstrated efficacy across multiple preclinical hearing loss models, including drug-induced ototoxicity.
The PROHEAR Study, a double-blind, randomised, placebo-controlled, split-body, multicentre Phase 2 trial, aims to assess whether Bimokalner can prevent ototoxic hearing loss induced by cisplatin.
Participants in the trial are 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 greater than 300 mg/m2 lead to clinically meaningful, permanent hearing loss in the majority of patients.
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