Sensorion SA announced that the initiation of a Proof of Concept (PoC) clinical trial of SENS-401 (Arazasetron) in patients with Cisplatin-Induced Ototoxicity (CIO) has been approved by regulatory authorities in France. Cisplatin and other platinum-based compounds are essential chemotherapeutic agents for many cancers. A serious side effect of these therapies is ototoxicity, or permanent and irreversible hearing loss, in 50-60% of adult patients and 90% of pediatric patients who survive cancer.

This indication represents a very significant unmet need for patients and is a large market with an estimated incidence of more than 500,000 patients in the United States, the European Union and Japan. Approval has been granted to conduct a Phase 2a trial with SENS-401 in CIO. Following extensive analysis of the AUDIBLE-S study data earlier in 2022, Sensorion has adapted the design of this trial to focus the prevention of hearing loss.

The exploratory, Phase 2a, multicenter, randomized, controlled, open-label study, NOTOXIS, will evaluate the efficacy of SENS-401 to prevent the ototoxicity induced by cisplatin in adult subjects with a neoplastic disease. The trial will assess several endpoints, including the rate and severity of ototoxicity, the change in the pure tone audiometry PTA (dB) and tolerance. First patient enrolment is expected by end of 2022.