The German Regulatory Authorities (BfArM) have granted regulatory approval to Acousia Therapeutic’s Phase II trial for the treatment of patients with cisplatin-induced hearing loss.

ACOU085 is an aetiology-agnostic otoprotectant while cisplatin is a chemotherapy medication used to treat a wide range of cancers including testicular, ovarian and cervical. Ototoxicity is a dose-limiting side effect of the medication, causing irreversible hearing loss in many patients.

The trial is a multi-centre, randomised, placebo-controlled, split-body trial that will observe and evaluate how effective ACOU085 is at preventing cisplatin-induced toxicity. The study will recruit young male patients with testicular cancer.

The study will assess efficacy outcomes for ACOU085, such as otoacoustic emissions, changes in high frequency and pure-tone audiometry. The trial is not yet open for recruitment, with enrolment of the first patient expected in Q4 2023.

Germany-based biotech company Acousia Therapeutics presented its key learnings and data from the ACOU085 programme at the 3rd Annual Inner Ear Disorders Therapeutics Summit in Boston, which was held from 29 August to 5 September.

ACOU085 showed good safety and tolerability in Phase I trials, using the standard transtympanic administration of a slow-release gel formulation.

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Acousia’s CEO Tim Boelke said: “Cisplatin is a lifeline for cancer patients, yet the heartache of hearing loss it brings is devastating.” He added that the ACOU085 trial “validates our experimental approach and offers the promise of hearing protection as patients battle cancer”.