Sensorion (EPA: ALSEN) announced the selection of SENS-601 which addresses GJB2-related hearing loss as its lead program. A clinical trial application has been filed in Canada and France to evaluate the safety, tolerability and efficacy of intra-cochlear administration of SENS-601, for the treatment of GJB2 gene-mediated hearing loss in paediatric patients.
Moreover, SENS-601 has been granted Fast Track procedure by the French National Agency for the Safety of Medicines and Health Products. According to Sensorion, the IND submission with the FDA in the U.S. and the submission in Australia are on track by year-end 2026.
In a statement, Fred Chereau, CEO of Sensorion, commented, “On behalf of Sensorion, I wish to express our sincere gratitude to the patients and their families for their courage and trust, and to the investigators for their exceptional dedication in the Audiogene trial. In my early weeks at Sensorion, working closely with the board, management team, and our scientific partners, I am confident that dedicating our gene therapy development resources to SENS-601 is the right strategic decision. GJB2-related hearing loss is the most common cause of genetic deafness, affecting a large patient population. The scientific, clinical, and operational foundation built through SENS-501 gives us a meaningful head start in advancing SENS-601 toward the clinic. With the regulatory progress announced today, built on years of dedicated work by our teams and the strength of our partnership with the Institut Pasteur – Institut reConnect/Institut de l’Audition, we are entering a genuinely exciting phase for the program and the company, as SENS-601 is positioned to be among the leading gene therapies to enter clinical development for this debilitating hearing loss disorder. I am fully committed to executing on this opportunity and delivering on the promise of gene therapy for patients and families.”
