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Sensorion Completes Patient Enrollment in Phase 2a Trial of SENS-401 for Cisplatin-Induced Hearing Loss Prevention

• Sensorion has enrolled the final patient in its NOTOXIS Phase 2a trial evaluating SENS-401 for preventing hearing loss caused by cisplatin chemotherapy, with 47 patients randomized across treatment and control groups.

• Preliminary results from 16 patients suggest SENS-401 may provide otoprotective effects at cisplatin doses exceeding 300 mg/m², addressing a serious side effect that affects 40-60% of cancer patients receiving platinum-based chemotherapy.

• The oral small molecule therapy is administered before, during, and after chemotherapy treatment, with topline results from the full study expected by the end of 2025.

Sensorion has announced the completion of patient enrollment in its NOTOXIS Phase 2a clinical trial evaluating SENS-401 (Arazasetron) for the prevention of Cisplatin-Induced Ototoxicity (CIO). The trial represents a significant step toward addressing the permanent hearing loss that affects 40-60% of patients receiving cisplatin-based chemotherapy treatments.
The multicenter, randomized, controlled, open-label proof-of-concept study has enrolled a total of 47 adult patients with neoplastic disease, with 24 patients randomized to receive SENS-401 and 23 in the control group. The trial will assess the efficacy of SENS-401 in preventing hearing loss four weeks after completion of cisplatin-based chemotherapy.

Trial Design and Endpoints

Patients in the treatment arm receive 43.5 mg of SENS-401 orally, twice daily, for up to 23 weeks. The treatment regimen begins one week prior to cisplatin therapy initiation and continues throughout chemotherapy (estimated to last up to 18 weeks) and for four weeks after chemotherapy completion.
The primary endpoint measures changes in pure tone audiometry (PTA) compared to baseline measurements taken before cisplatin treatment. Secondary endpoints include:
  • Safety profile assessment
  • Changes in speech discrimination (in noise versus quiet environments)
  • Impact on tinnitus using the tinnitus handicap inventory (THI) scale
Dr. Géraldine Honnet, Chief Medical Officer of Sensorion, commented: "Today's announcement marks a key development milestone for SENS-401, our small molecule therapeutic candidate that has potential to mitigate the irreversible and permanent hearing loss frequently seen in adults following cisplatin-based chemotherapies without interfering with cisplatin efficacy."

Promising Preliminary Results

Preliminary data from 16 patients presented at the World Congress of Audiology in Paris (September 2024) showed encouraging results. The data suggested SENS-401's potential to achieve an otoprotective effect at cisplatin doses exceeding 300 mg/m². Additionally, the company reported a favorable safety profile from this preliminary analysis.
Sensorion expects to report topline results from the complete Phase 2a NOTOXIS study by the end of 2025.

Addressing a Significant Unmet Need

Cisplatin and other platinum-based compounds are essential chemotherapeutic agents used to treat many cancers. However, ototoxicity—permanent and irreversible hearing loss—represents a serious side effect affecting a substantial percentage of both adult and pediatric patients.
This hearing loss can significantly impact quality of life, creating a substantial unmet medical need. SENS-401 aims to protect and preserve inner ear tissue from damage responsible for progressive or sequelae hearing impairment.

Regulatory Status and Development Pipeline

SENS-401 has received Orphan Drug Designation from the European Medicines Agency (EMA) for the treatment of sudden sensorineural hearing loss. The U.S. Food and Drug Administration (FDA) has also granted this designation for the prevention of platinum-induced ototoxicity in the pediatric population.
Beyond the NOTOXIS trial, Sensorion has completed a Phase 2a study of SENS-401 for preventing residual hearing loss in patients scheduled for cochlear implantation, in partnership with Cochlear Limited. The company also completed a Phase 2 study in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022.

About Sensorion

Sensorion is a clinical-stage biotechnology company specializing in developing novel therapies to restore, treat, and prevent hearing loss disorders. The company has built a unique R&D technology platform to understand the pathophysiology and etiology of inner ear diseases, enabling targeted drug candidate development.
In addition to SENS-401, Sensorion's pipeline includes two gene therapy programs developed in collaboration with Institut Pasteur. These programs aim to correct hereditary monogenic forms of deafness:
  • SENS-501 (OTOF-GT): Currently in Phase 1/2 clinical trials, targeting deafness caused by mutations of the gene encoding for otoferlin
  • GJB2-GT: Targeting hearing loss related to mutations in the GJB2 gene
The company is also working on identifying biomarkers to improve diagnosis of these underserved conditions, addressing a significant global unmet medical need in hearing health.
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