Summary: Sensorion announced that the independent Data Safety Monitoring Board has reviewed and approved the continuation of the NOTOXIS Phase 2a clinical study of SENS-401, confirming its safety in preventing Cisplatin-Induced Ototoxicity.
Takeaways:
- Safety Confirmation: The DSMB’s review confirmed the safety of SENS-401 for adult patients receiving a daily dose of 43.5 mg, administered twice daily for up to 23 weeks.
- Steady Enrollment and Progress: Patient enrollment is progressing steadily across 13 clinical centers, with preliminary safety and efficacy data to be reported at the World Congress of Audiology in September 2024.
- Multicenter Phase 2a Trial: The NOTOXIS Phase 2a trial is designed to assess the efficacy of SENS-401 in preventing ototoxicity from cisplatin chemotherapy, with endpoints including ototoxicity rate, pure tone audiometry changes, and tolerability.
Sensorion, a clinical-stage biotechnology company that specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, announced that the independent Data Safety Monitoring Board (DSMB) has undertaken a review of the safety data for the patients participating in the NOTOXIS Phase 2a Proof-of-Concept (POC) clinical study of SENS-401 for the prevention of Cisplatin-Induced Ototoxicity (CIO).
The DSMB has recommended the continuation of the study and confirmed the absence of any concern as to the safety of SENS-401 when administered in adult patients receiving a daily dose of 43.5 mg, administered twice daily, over a period of up to 23 weeks. Data previously published in December 2023, indicated a favorable safety profile when administered continuously for up to 11 weeks in patients receiving SENS-401.
Further reading: Sound Pharma Gets Positive Data from Trial Treating Aminoglycoside-Induced Ototoxicity
The patient enrolment continues to progress at a steady pace, in 13 clinical centers open to date. Sensorion’s management team will report preliminary safety and efficacy data of the Phase 2a POC clinical trial of SENS-401 CIO at the World Congress of Audiology, to be held on September 19-22, 2024, in Paris, France.
What is NOTOXIS Phase 2a
The NOTOXIS Phase 2a trial is a multicenter, randomized, controlled, open-label study designed to assess the efficacy of SENS-401 in preventing cisplatin-induced ototoxicity in adult patients with neoplastic disease, four weeks after completion of cisplatin-based chemotherapy. The trial assesses several endpoints, including the rate and severity of ototoxicity, changes in pure tone audiometry (PTA) (dB) throughout the study compared to before cisplatin treatment, and tolerability.
About SENS-401
SENS-401, Sensorion’s clinical stage lead drug candidate, is an orally available small molecule that aims to protect and preserve inner ear tissue from damage responsible of progressive or sequelae hearing impairment. Sensorion currently develops SENS-401 in a Phase 2a for the prevention of residual hearing loss in patients scheduled for cochlear implantation and in a Phase 2 clinical trial for the prevention of Cisplatin-Induced Ototoxicity. SENS-401 has been granted Orphan Drug Designation by the EMA in Europe for the treatment of sudden sensorineural hearing loss, and by the FDA in the U.S. for the prevention of platinum-induced ototoxicity in pediatric population.
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