Sensorion Prioritizes SENS-601 as Main Program and Discontinues SENS-501
Biotech company Sensorion announced on Wednesday that it has selected SENS-601, a gene therapy aimed at treating hearing loss associated with mutations in the GJB2 gene, as its main development program. Concurrently, the company is discontinuing the clinical development of SENS-501 to redirect resources towards this candidate.
Filing of Clinical Trial Applications in Europe and Accelerated Procedure in France
Sensorion has submitted clinical trial applications for SENS-601 in Canada and France. The French regulatory agency (ANSM) has granted an accelerated procedure for the French application, significantly reducing the review time compared to the standard procedure. Filings with the FDA in the United States and submissions in Australia are planned by the end of 2026. The trial, named Hearconnex, will assess the safety, tolerance, and efficacy of intracochlear administration of SENS-601 in pediatric patients with deafness related to the GJB2 gene. Preliminary discussions with regulatory authorities have been constructive, and the company considers its dossier complete and scientifically robust.
Discontinuation of SENS-501 and Resource Reallocation to SENS-601
Sensorion is terminating the Audiogene trial and ceasing the clinical development of SENS-501 (OTOF-GT), aimed at treating an ultra-rare form of deafness linked to mutations in the OTOF gene. This shift follows a strategic review of the therapeutic portfolio and takes into account the emergence of an already approved gene therapy for this ultra-rare indication. The reallocation of resources to SENS-601 addresses a significantly larger unmet medical need, according to the management and board of directors. GJB2 is the most common cause of genetic deafness, responsible for about 50% of non-syndromic autosomal recessive hearing losses. SENS-601 could potentially treat three distinct conditions: pediatric congenital deafness, progressive forms of hearing loss in children, and early stages of presbycusis in adults.
Financial Autonomy Extended Until End of 2027
Sensorion's cash reserves will allow it to continue operations until the end of 2027. This extension is intended to support the clinical advancement of SENS-601 and the generation of initial human data.
