Sensorion has selected SENS-601, a gene therapy targeting GJB2-related hearing loss, as its lead program following a strategic review of its pipeline. The company filed Clinical Trial Applications in Canada and France to evaluate the safety, tolerability, and efficacy of intra-cochlear administration of SENS-601 in pediatric patients. The French Agency (ANSM) granted a Fast Track procedure, which significantly reduces the assessment period compared to the standard pathway. Sensorion targets an IND submission in the U.S. and a submission in Australia by year-end 2026.

As part of the strategic shift, Sensorion will discontinue the clinical development of SENS-501 for OTOF-related hearing loss and end recruitment in the Audiogene trial. The Board and management determined that concentrating resources on SENS-601, which addresses the most common cause of genetic deafness, is the optimal decision given the larger unmet need and the absence of approved therapies. The scientific and operational platform developed for SENS-501 is directly transferrable to SENS-601, providing a foundational head start.

SENS-601 originated from a gene therapy platform co-developed with the Institut Pasteur. It aims to treat hearing loss linked to mutations in the GJB2 gene, which is responsible for approximately 50% of autosomal recessive non-syndromic hearing loss. The therapy has the potential to address pediatric congenital deafness, progressive hearing loss in children, and early onset presbycusis in adults. The program is partially funded by the French State as part of the France 2030 investment plan.

Fred Chereau, Chief Executive Officer of Sensorion, stated that dedicating gene therapy development resources to SENS-601 is the right strategic decision. He emphasized that GJB2-related hearing loss affects a large patient population and that the foundation built through SENS-501 provides a meaningful head start. Chereau expressed confidence in the regulatory progress and the strength of the partnership with the Institut Pasteur.

Christine Petit, Professor at Institut Pasteur and laureate of the Kavli Prize in Neurosciences, highlighted the robust data demonstrating significant hearing restoration after SENS-601 administration in animal models. She noted that the scientific and clinical advances from the Audiogene trial are directly guiding the development of SENS-601. The collaboration involves multidisciplinary teams from the Institut Pasteur, Necker Enfants-Malades Hospital, and the Fondation Pour l'Audition.

Sensorion has extended its cash runway until the end of 2027 to support the execution of the clinical advancement of SENS-601 and the generation of first-in-human data. The company remains committed to ensuring the long-term follow-up of all patients enrolled in the Audiogene trial in accordance with regulatory requirements.

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