Sensorion Receives DSMB Approval to Proceed with NOTOXIS Phase 2a Trial of SENS-401 for Cisplatin-Induced Ototoxicity

Sensorion, a clinical-stage biotechnology company based in Montpellier, France, focuses on developing innovative therapies to address hearing loss disorders. The company recently announced a significant update regarding its Phase 2a Proof-of-Concept (POC) clinical study of SENS-401, a drug aimed at preventing Cisplatin-Induced Ototoxicity (CIO).

The independent Data Safety Monitoring Board (DSMB) conducted a thorough review of the safety data from patients participating in the NOTOXIS Phase 2a study. The DSMB confirmed the safety of SENS-401 for adult patients receiving a daily dose of 43.5 mg, administered twice daily over up to 23 weeks. This follows data published in December 2023, which had shown a positive safety profile for SENS-401 when used for up to 11 weeks.

Sensorion’s management reports that patient enrollment for the study is progressing steadily across 13 clinical centers. Preliminary safety and efficacy data are expected to be presented at the World Congress of Audiology, scheduled for September 19-22, 2024, in Paris, France.

The NOTOXIS Phase 2a trial is a multicenter, randomized, controlled, open-label study designed to evaluate the efficacy of SENS-401 in preventing ototoxicity caused by cisplatin in adult patients with cancer. This evaluation occurs four weeks after the completion of cisplatin-based chemotherapy. The trial measures multiple endpoints such as the incidence and severity of ototoxicity, changes in pure tone audiometry (PTA) compared to pre-cisplatin levels, and tolerability of the drug.

SENS-401, also known as Arazasetron, is an orally available small molecule that aims to protect inner ear tissue from damage leading to hearing loss. Sensorion is exploring SENS-401 in several clinical contexts: in a Phase 2a trial for preventing hearing loss in patients scheduled for cochlear implantation and in a Phase 2 trial for preventing Cisplatin-Induced Ototoxicity. The drug has been granted Orphan Drug Designation by the EMA in Europe for treating sudden sensorineural hearing loss and by the FDA in the U.S. for preventing platinum-induced ototoxicity in pediatric patients.

Sensorion, as a pioneering biotech company, focuses on developing novel therapies to address hearing loss – a significant, unmet global medical need. The company leverages its unique R&D technology platform to deepen its understanding of the pathophysiology and etiology of inner ear diseases. This platform helps Sensorion identify optimal targets and mechanisms for drug candidates.

Sensorion's portfolio includes two gene therapy programs aimed at correcting hereditary forms of deafness, developed in collaboration with the Institut Pasteur. The SENS-501 (OTOF-GT) program targets deafness caused by otoferlin gene mutations, and the GJB2-GT program addresses hearing loss from GJB2 gene mutations, potentially benefiting both adults and children. Additionally, Sensorion is working on biomarker identification to enhance the diagnosis of these conditions.

The company’s clinical-stage portfolio also features small molecule programs for treating and preventing hearing loss. This includes a Phase 2 study of SENS-401 for Cisplatin-Induced Ototoxicity and a collaborative study with Cochlear Limited for patients undergoing cochlear implantation. A Phase 2 study of SENS-401 for Sudden Sensorineural Hearing Loss (SSNHL) was completed in January 2022.