Sensorion Completes Patient Enrollment in NOTOXIS Phase 2a Trial of SENS-401
Sensorion (FR0012596468 – ALSEN), a clinical-stage biotechnology company focused on developing novel therapies for hearing loss, has announced the completion of patient enrollment in its NOTOXIS Phase 2a clinical trial. The trial aims to evaluate the efficacy of SENS-401 in preventing cisplatin-induced ototoxicity (CIO), a side effect that causes permanent hearing loss in patients undergoing chemotherapy.
The NOTOXIS trial (ClinicalTrials.gov ID: NCT05628233) is designed to test the potential of SENS-401 in preventing hearing damage caused by cisplatin, a chemotherapy drug commonly used to treat various cancers. The trial is enrolling adult patients with neoplastic disease who are receiving cisplatin-based chemotherapy. The study will assess the impact of SENS-401 on hearing function four weeks after the completion of chemotherapy.
A total of 80 patients were enrolled in the multicenter, randomized, controlled, open-label Phase 2a trial. Forty-eight patients were randomized, with 24 in the SENS-401 treatment group and 24 in the control group. Patients in the treatment group were administered 43.5 mg of SENS-401 orally, twice daily, starting one week before cisplatin chemotherapy and continuing for up to 23 weeks (including four weeks post-treatment). The control group will serve as a baseline to compare the occurrence and timing of ototoxicity following cisplatin administration.
The primary endpoint of the trial is the change in pure tone audiometry (PTA), a measure of hearing function, compared to pre-chemotherapy measurements, four weeks after the last dose of cisplatin. Secondary endpoints include safety, changes in speech understanding in noisy versus quiet environments, and changes in Tinnitus Handicap Inventory (THI) scores.
Preliminary results from the trial, based on data from 16 patients, were presented at the World Congress of Audiology in Paris in September 2024. These results suggest a potential otoprotective effect of SENS-401, particularly at cisplatin doses greater than 300 mg/m². The preliminary data also indicated a favorable safety profile for the drug.
Sensorion is on track to report topline results from the NOTOXIS Phase 2a study by the end of the second half of 2025. Dr. Géraldine Honnet, Chief Medical Officer of Sensorion, expressed optimism about the trial’s progress: “Today’s announcement marks a key milestone in the development of SENS-401, our small molecule therapeutic with the potential to alleviate irreversible hearing loss, a frequent side effect of cisplatin chemotherapy. The preliminary results are encouraging, and I look forward to evaluating the full data from all patients treated in the NOTOXIS trial. We expect to report topline results by the end of 2025.”
Cisplatin and other platinum-based chemotherapy drugs are essential for treating a variety of cancers, but they are also associated with a serious side effect: ototoxicity, which leads to permanent and irreversible hearing loss in 40–60% of adult and pediatric patients. The unmet medical need for effective therapies to prevent this side effect is significant, making it a large potential market for treatments that can protect hearing during chemotherapy.
About SENS-401
SENS-401 (Arazasetron) is an orally available small molecule developed by Sensorion to protect and preserve inner ear tissue from damage, aiming to prevent hearing loss caused by cisplatin-induced ototoxicity. The drug is currently undergoing clinical testing in several trials. In addition to the Phase 2a trial for cisplatin-induced ototoxicity, SENS-401 has also been tested in a Phase 2a study to prevent residual hearing loss in patients undergoing cochlear implantation.
SENS-401 has received orphan drug designation from the European Medicines Agency (EMA) for treating sudden sensorineural hearing loss and from the U.S. Food and Drug Administration (FDA) for the prevention of platinum-induced ototoxicity in pediatric patients.
About Sensorion
Sensorion is a clinical-stage biotechnology company specializing in the development of novel therapies for hearing loss disorders, a significant global unmet medical need. The company has a unique research and development platform focused on understanding the pathophysiology of inner ear diseases and developing targeted drug candidates.
In addition to its work on SENS-401, Sensorion is advancing gene therapy programs to correct hereditary monogenic forms of deafness. Through its collaboration with the Pasteur Institute, the company is developing SENS-501 (OTOF-GT), a gene therapy for deafness caused by mutations in the otoferlin gene, and GJB2-GT, which targets hearing loss caused by mutations in the GJB2 gene. These therapies are currently in Phase 1/2 clinical trials.
Sensorion’s portfolio also includes small molecule therapies for the prevention and treatment of hearing loss, and the company is working to identify biomarkers that can improve the diagnosis and treatment of hearing-related diseases.
