Sensorion Announces New Positive Clinical Data Across its Gene Therapy and Small Molecule Programs at the World Congress of Audiology in Paris

Regulatory News:

Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announces new positive medical data from its clinical programs SENS-501 and SENS-401 during a symposium (12.30-1.30pm CET) and in an oral presentation on SENS-401 (11.15am CET) organized as part of the 36^th World Congress of Audiology (WCA), held in Paris at the CNIT, La Défense, France.

The Company reports today new data across its pipeline of gene therapy (SENS-501) and small molecule (SENS-401) programs. Details of these medical advances will be presented by Professor Natalie Loundon, ENT Surgeon in the pediatric Hospital Necker-Enfants malades in Paris, France, Professor Catherine Birman (Otorhinolaryngologist, Director of the Sydney Cochlear Implant Centre, Australia), Professor Yann Nguyen (ENT Surgeon, Pitié Salpétrière Hospital, Paris, France), Professor Stephen O’Leary (Head of Otorhinolaryngology, University of Melbourne, Australia) and Professor Christophe Vincent (Head of Otology and Otoneurology, ENT surgeon, Salengro Hospital, Lille, France).

Gene Therapy

• Audiogene (OTOF-GT): Professor Catherine Birman will report initial positive safety results on the first patient injected in Sensorion’s Phase 1/2 gene therapy clinical trial of SENS-501, dedicated to restoring hearing in patients suffering from otoferlin deficiency, one of the most common forms of congenital deafness. The surgery was well tolerated by the patient and no safety signals were reported. From early observations, changes in the child's behaviour and vocalisations were noted.
  
  
• Audiogene, aims to evaluate the safety, tolerability, and efficacy of intra-cochlear injection of SENS-501 for the treatment of OTOF gene-mediated hearing impairment in paediatric patients aged 6 to 31 months at the time of gene therapy treatment. Targeting the first years of life, the time period when the auditory system plasticity is optimal, will maximize the chances of these young children with pre-lingual hearing loss to acquire normal speech and language. The design of the study consists of two cohorts of two doses followed by an expansion cohort at the selected dose. While the safety will be the primary endpoint for the dose escalation cohort, the auditory brainstem response (ABR) will be the primary efficacy endpoint of the dose expansion cohort.

Small Molecule