Sensorion SA (ALSEN.PA), a biotechnology company, on Wednesday announced the selection of SENS-601 for treating GJB2-related hearing loss as the company's lead program, and the simultaneous discontinuation of the Audiogene trial evaluating SENS-501 in the treatment of OTOF-related hearing loss.
Following the announcement, shares fell over 15% on Wednesday.
GJB2 mutations are the most common genetic causes of congenital deafness, responsible for about 50% of autosomal recessive non-syndromic hearing loss cases.
SENS-601 (GJB2-GT) is an AAV-based gene therapy developed to treat GJB2-associated hearing loss. The drug has the potential to treat pediatric congenital deafness, progressive hearing loss in children, and early onset of presbycusis in adults.
The advancement of SENS-601 as the company's lead program was accompanied by applications to initiate the Hearconnex clinical trials in Canada and France, with a Fast Track designation granted by the French National Agency for Medicines and Health Products Safety (ANSM). The Hearconnex trials will evaluate safety, tolerability, and efficacy of the intra-cochlear administration of SENS-601 in pediatric patients.
The SENS-501 gene therapy was developed to target the otoferlin gene (OTOF), which effects transmission of auditory signals between the hair cells of the inner ear and the auditory nerve. Mutations in the OTOF gene can cause severe to profound hearing loss. The therapy was being assessed in the Phase 1/2 Audiogene trial, which showed positive results prior to discontinuation.
However, Otarmeni, a gene therapy from Regeneron Pharmaceuticals Inc., received FDA approval in April for the treatment of OTOF-related hearing loss. The company attributed the termination of the Audiogene program for SENS-501 to the availability of the Otarmeni therapy, stating that resources would be better directed toward development of SENS-601 in treating GJB2-related hearing loss, which is an affliction with no currently approved therapies.
Sensorion plans to submit an investigational new drug (IND) application for SENS-601 to the U.S. FDA and in Australia by the end of 2026.
ALSEN.PA is currently trading on the Paris Stock Exchange at EUR 0.31, down 15.52%.
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