MONTPELLIER, FRANCE — Sensorion (FR0012596468 – ALSEN), a leading clinical-stage biotechnology company specializing in innovative therapies for hearing-related conditions, has announced the successful recruitment of the final participant in its Phase 2a clinical trial of SENS-401.
This trial aims to evaluate the efficacy of SENS-401 in preserving residual hearing in adult patients undergoing cochlear implantation.
Preserving Residual Hearing in Cochlear Implant Patients
The multicentric, randomized, controlled open-label Phase 2a trial enrolled a total of 33 patients, with at least 27 patients slated to participate. The study assesses the presence of SENS-401 in the cochlea (perilymph) after 7 days of twice-daily oral administration in adult patients with moderately severe to profound hearing impairment, prior to cochlear implantation.
Patients receive SENS-401 treatment for 7 days before implantation and continue for an additional 42 days. Developed in collaboration with Cochlear Limited, the trial aims to advance the understanding of SENS-401’s potential benefits in preserving hearing.
Dr. Géraldine Honnet, Chief Medical Officer at Sensorion, expressed delight at the completion of patient recruitment, emphasizing its significance in advancing the SENS-401 development plan. Dr. Honnet commended the patients and physicians involved for their trust and dedication to the study.
Initial data from the trial indicate promising outcomes, with SENS-401 demonstrating clinically significant effects in preserving residual hearing following cochlear implantation. Sensorion plans to release primary endpoint data readout in the first half of 2024.
About SENS-401
SENS-401 (Arazasetron) is Sensorion’s lead drug candidate, designed to protect and preserve inner ear tissue from damage leading to progressive or sequelae hearing impairment. The Phase 2a trial evaluates SENS-401’s potential to prevent residual hearing loss in patients undergoing cochlear implantation, while another Phase 2 trial assesses its efficacy in preventing Cisplatin Induced Ototoxicity. SENS-401 has received Orphan Drug Designation from the EMA in Europe for treating sudden sensorineural hearing loss and from the FDA in the U.S. for preventing platinum-induced ototoxicity in pediatric populations.
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
