MONTPELLIER, FRANCE – Sensorion (FR0012596468 – ALSEN), a leading clinical-stage biotechnology company specializing in therapies for hearing loss disorders, has announced a positive recommendation from the independent Data Safety Monitoring Board (DSMB) for the continuation of its NOTOXIS Phase 2a Proof-of-Concept (POC) clinical trial. This trial investigates the efficacy and safety of SENS-401 in preventing Cisplatin-Induced Ototoxicity (CIO).
The DSMB reviewed safety data from patients receiving SENS-401 and confirmed no safety concerns. Patients in the trial receive a daily dose of 43.5 mg of SENS-401, administered twice daily over a period of up to 23 weeks. Previous data, published in December 2023, also indicated a favorable safety profile for SENS-401 when administered for up to 11 weeks.
The trial is progressing steadily with patient enrollment across 13 clinical centers. Preliminary safety and efficacy data from the Phase 2a POC clinical trial will be presented at the World Congress of Audiology, scheduled for September 19-22, 2024, in Paris, France.
About the NOTOXIS Phase 2a Trial
The NOTOXIS Phase 2a trial is a multicenter, randomized, controlled, open-label study aimed at assessing the efficacy of SENS-401 in preventing ototoxicity caused by cisplatin in adult patients undergoing chemotherapy. The trial evaluates several endpoints, including the rate and severity of ototoxicity, changes in pure tone audiometry (PTA), and overall tolerability.
About SENS-401
SENS-401 (Arazasetron) is Sensorion’s lead clinical-stage drug candidate. It is an orally available small molecule designed to protect and preserve inner ear tissue from damage that can cause progressive or permanent hearing impairment. SENS-401 is currently in Phase 2a trials for preventing residual hearing loss in patients scheduled for cochlear implantation and for preventing Cisplatin-Induced Ototoxicity. The drug has been granted Orphan Drug Designation by both 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.
About Sensorion
Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates.
It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. OTOF-GT targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses.
Sensorion’s portfolio also comprises clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders.
Sensorion’s clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022.
Source: Sensorion
