Sensorion Completes Patient Enrollment in Audiogene Phase 1/2 Gene Therapy Clinical Trial, No Serious Adverse Events Reported.

Sensorion has completed patient enrollment for the second cohort of its Phase 1/2 Audiogene clinical trial for its gene therapy candidate SENS-501. The trial aims to treat congenital deafness linked to mutations in the OTOF gene. Three patients aged 6-31 months received a higher dose of SENS-501, with no serious adverse events or side effects reported. Early signs of hearing improvement have been observed in one patient. The next steps include a Data Monitoring Committee meeting and further data analysis.

Montpellier, France—Sensorion (FR0012596468 – ALSEN), a pioneering clinical-stage biotechnology company specializing in novel therapies for hearing loss disorders, has announced the completion of patient enrollment for the second cohort of its Phase 1/2 Audiogene clinical trial. The trial evaluates SENS-501, a gene therapy candidate designed to treat congenital deafness linked to mutations in the OTOF gene.

The second cohort, consisting of three patients aged between 6 and 31 months, received a higher dose of SENS-501 compared to the first cohort. The surgical procedure was well tolerated, with no serious adverse events or side effects reported. Early signs of hearing improvement were observed in one patient, aged 11 months at the time of injection, three months after receiving the low dose.

Nawal Ouzren, Chief Executive Officer of Sensorion, commented, "The completion of patient enrollment in the second cohort in Audiogene is an important milestone as it enables us to attest to the safety of the surgical approach and the good tolerability of SENS-501 to date. I look forward to advancing this innovative and unique program to its next steps, notably with the planned Data Monitoring Committee meeting, and to providing an update as soon as the data have sufficiently matured. On behalf of my colleagues, I would like to extend gratitude to the patients' families for their trust, as well as all the healthcare professionals involved in this clinical trial."

Professor Natalie Loundon, M.D., Director of the Center for Research in Pediatric Audiology and Principal Investigator of the Audiogene clinical study, added, "I am thrilled we have successfully completed the patient enrollment of the second Cohort in Audiogene’s Phase 1/2 gene therapy trial. The good tolerability of patients to SENS-501 so far and the preliminary positive data from the first cohort are very encouraging first steps for the continuation of this trial that has the potential to address a global significant unmet medical need. Once again, I would like to thank the patients' families for their trust."

The next steps for Sensorion include a Data Monitoring Committee meeting and further data analysis to evaluate the safety, tolerability, and efficacy of SENS-501. The trial aims to assess the gene therapy product’s capacity to restore hearing and allow infants and toddlers to acquire and develop normal speech. Additionally, it will evaluate the usability, clinical, and technical performances of the injection system in development.

The Audiogene clinical trial design has been intended to assess SENS-501 gene therapy product’s safety and tolerability as well as its capacity not only to restore hearing but also to allow the infants and toddlers to acquire and develop normal speech. Moreover, Audiogene aims to evaluate the usability, the clinical and the technical performances of the injection system in development.

Sensorion is a pioneering clinical-stage biotech company that specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. The company 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.

References:
[1] https://www.businesswire.com/news/home/20250728154446/en/Sensorion-Completes-Patient-Enrollment-of-the-Second-Cohort-in-Audiogene-Phase-12-Gene-Therapy-Clinical-Trial
[2] https://apnews.com/article/sarepta-muscular-dystophy-death-fda-gene-therapy-0cab4d676c93f679b7b35d9830b2b57d