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Acousia Therapeutics announced positive top-line results from its completed Phase 2a PROHEAR study evaluating ACOU085, also known as "bimokalner," for prevention of hearing loss caused by cisplatin chemotherapy.
Cisplatin is a widely used cancer drug that frequently causes permanent damage to the cochlea. In PROHEAR, more than 90% of participants, men aged 18 to 45 receiving cisplatin for testicular cancer, developed hearing damage in at least one ear during treatment. The trial used a split-body design: each participant received a single dose of ACOU085 in one ear and a placebo in the other. Participants who developed damage showed less worsening of hearing thresholds in the ACOU085-treated ear.
ACOU085 is delivered by injection into the middle ear. It works by activating potassium channels that help maintain the ionic conditions the cochlea needs to function. The company says the mechanism may have potential beyond cisplatin-related damage, though PROHEAR was limited to that population.
This was an exploratory study with a limited sample. Full peer-reviewed data has not yet been published.
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