Sensorion Shares Positive Clinical Results at World Congress of Audiology

Sensorion, a clinical-stage biotechnology company based in Montpellier, France, specializes in developing innovative therapies for hearing loss disorders. Recently, Sensorion announced significant progress in its clinical programs, SENS-501 and SENS-401, during a symposium on September 20, 2024, and at the 36th World Congress of Audiology in Paris.

Nawal Ouzren, Sensorion's CEO, highlighted the company's strides in gene therapy for hearing restoration, particularly through the Audiogene clinical trial. This trial targets young patients with severe to profound hearing loss caused by otoferlin gene mutations. Regulatory approval for this gene therapy was granted in January 2024, and the first patient has already been treated, with two more screened. The trial aims to treat the first cohort by the end of 2024. Ouzren expressed gratitude towards the patients' families and study investigators.

The SENS-401 portfolio also showed promising developments. The Phase 2a trial, conducted in collaboration with Cochlear Limited, focused on preserving residual hearing post-cochlear implantation. The trial met positive secondary efficacy endpoints. Another Phase 2a trial targeting Cisplatin-Induced Ototoxicity is progressing, with recruitment expected to complete in the first half of 2025.

The Audiogene trial for SENS-501 is a significant part of Sensorion's efforts. Conducted in Australia by Professor Catherine Birman's team, this trial assesses the safety, tolerability, and efficacy of SENS-501 in children aged 6 to 31 months with otoferlin gene mutations. The trial design includes two dose cohorts followed by an expansion cohort. While safety is the primary endpoint for the dose escalation phase, the auditory brainstem response (ABR) serves as the primary efficacy endpoint for the dose expansion phase. Sensorion plans to complete the first patient cohort by the end of 2024 and expects to publish initial efficacy data by then.

Professor Birman expressed enthusiasm for the gene therapy trial, emphasizing its potential to transform the lives of children with OTOF gene mutations. She thanked the families for their trust and looked forward to further recruitment and follow-up.

In the SENS-401 program, which focuses on preserving residual hearing post-cochlear implantation, Sensorion completed a Phase 2a trial. The trial involved 16 patients treated with SENS-401 and 8 in the control group. Results showed that SENS-401 effectively preserved residual hearing across various frequencies. This protective effect persisted even 8 weeks post-treatment. The trial confirmed the presence of SENS-401 in the perilymph fluid, meeting its primary endpoint.

Stephen O’Leary from the University of Melbourne highlighted the importance of these findings, emphasizing the protective role of SENS-401 in cochlear implantation. Residual hearing is crucial for quality of life, as it helps patients understand speech in noisy environments and perceive more natural sounds.

Additionally, Sensorion's NOTOXIS program investigates SENS-401 for preventing Cisplatin-Induced Ototoxicity (CIO). Preliminary results from a Phase 2a trial indicate a potential otoprotective effect of SENS-401 in patients undergoing cisplatin chemotherapy. Despite significant cisplatin exposure, most participants showed only mild ototoxicity. The safety profile of SENS-401 was favorable, with no unexpected adverse events.

Professor Yann Nguyen from Pitié Salpétrière Hospital in Paris noted the debilitating nature of ototoxicity from cisplatin chemotherapy. He underscored the importance of developing therapeutic solutions like SENS-401 to prevent this condition without compromising the effectiveness of cisplatin.

Overall, Sensorion's promising clinical programs aim to address significant unmet medical needs in hearing loss disorders, providing hope for improved quality of life for affected patients.