#Germany #ACOU085 #Tübingen #Acousia #Bimokalner

Acousia Therapeutics Completes Patient Enrollment in Phase 2 PROHEAR Study

Overview

Acousia Therapeutics GmbH, a biotechnology company focused on developing treatments for inner ear hearing loss, has successfully completed patient enrollment in the Phase 2 PROHEAR clinical study. This significant milestone is crucial as the study evaluates the efficacy of ACOU085 (INN: Bimokalner), a novel compound aimed at preventing hearing loss due to cisplatin chemotherapy, a treatment commonly used for testicular cancer.

The Challenge of Cisplatin-Induced Hearing Loss

Cisplatin, a powerful chemotherapy drug, is known to induce severe permanent hearing loss in many patients—especially with cumulative doses of 300 mg/m² or more. This side effect is caused by irreversible damage to the outer hair cells of the cochlea. As the demand for effective cancer treatments grows, so does the necessity for strategies to mitigate these debilitating side effects.

PROHEAR Study Details

The PROHEAR study is a multicenter, double-blind, randomized, placebo-controlled trial that focuses on young male patients with metastatic testicular cancer who are to receive cisplatin-based chemotherapy. This innovative trial design includes administering either ACOU085 or a placebo prior to each chemotherapy cycle across participating leading university hospitals in Germany. Additionally, a series of audiometric tests will be conducted at baseline and after each chemotherapy cycle to assess hearing function.

Primary Objective

The primary aim of the PROHEAR Study is to investigate whether Bimokalner can effectively prevent ototoxic hearing loss associated with cisplatin. The design features within-patient, placebo-controlled comparisons of hearing outcomes, thus enhancing the reliability of findings and helping to validate Acousia Therapeutics’ Kv7.4 activator programs.

Management Insights

Tim Boelke, CEO and CMO of Acousia Therapeutics, emphasized the significance of this development, stating, “This drug candidate offers the potential to prevent permanent inner ear damage that is often the result of cisplatin-based chemotherapy. As we celebrate the completion of patient enrollment, I thank all participants and clinical teams for their dedication. Initial blinded results are promising, and we anticipate a thorough review of the unblinded data by mid-2026.”

Future Engagements

Boelke and fellow executives from Acousia will participate in JPM Week in San Francisco from January 12 to 15, 2026, where they will meet potential investors and partners during significant events, including the Biotech Showcase. This engagement aims to foster strategic collaborations that further Acousia’s mission of revolutionizing hearing loss treatments.

About ACOU085 (Bimokalner)

ACOU085 represents a groundbreaking advancement in otoprotective therapies, designed to be administered through transtympanic techniques utilizing a slow-release gel formulation. Bimokalner acts on the KCNQ4-encoded Kv7.4 potassium channel, known to be critical in maintaining the function of outer hair cells. Preclinical studies demonstrate the molecule's efficacy in reducing cisplatin-induced hearing loss, paving the way for a potential breakthrough in preserving hearing integrity in patients undergoing chemotherapy.

Conclusion

The completion of participant enrollment marks a pivotal step forward in addressing the issue of chemotherapy-induced hearing loss. Acousia Therapeutics is at the forefront of innovations in this field, and the results from the PROHEAR study may bring hope not only for patients but also for the future of hearing preservation strategies during cancer treatment.