MONTPELIER, France–(BUSINESS WIRE)– Regulatory News:
SENSION (FR0012596468 “ALSEN) A leading clinical-stage biotechnology company specializing in developing novel therapies to restore, treat and prevent hearing loss disorders today announces the completion of patient enrollment in the first cohort of the gene therapy Audiogene Phase 1/2 clinical trial.
Recruitment of the first group (three patients) was completed as planned, with the third patient receiving an injection of the gene therapy product SENS-501 in December 2024. For all patients treated in the first group, the surgical procedure was well tolerated: – cochlear administration was Production of the gene therapy product has been uneventful, and no serious adverse events have been reported. Audiogene is the first gene therapy clinical trial addressing a unique, homogeneous population of infants and young children (ages 6 to 31 months at time of injection) without cochlear implants. Audiogene's clinical trial design aims to evaluate the ability of the gene therapy product SENS-501 to not only restore hearing but also allow infants and young children to acquire and develop normal speech.
said Nawal Ozren, CEO of Sensorion: I am very pleased with the progress Sensorion has made in its Phase 1/2 gene therapy clinical trial. The injection of the third and final patient from the first group, less than a year after receiving clinical trial application authorization, is a major achievement for Sensorion. The infant's surgery was uneventful, and no serious adverse events were reported. I am very excited about the KOL event we are planning in early 2025, with leading field experts, to present and comment on the full range of data measurements. I look forward to developing SENS-501 and evaluating its ability to restore hearing and enable normal speech acquisition and development in treated toddlers and infants.
About the Audiogene experience
Audiogene aims to evaluate the safety, tolerability and efficacy of intracochlear injection of SENS-501 for the treatment of OTOF gene-induced hearing loss in infants and young children aged 6 to 31 months at the time of gene therapy treatment. By targeting the early years of life, when brain plasticity is optimal, the chances of these young children with prelingual hearing loss to acquire normal speech and language are maximized. The study consists of two two-dose arms followed by an expansion arm at the indicated dose. While safety will be the primary endpoint for the first part of the dose-escalation study, auditory brainstem response (ABR) will be the primary efficacy endpoint for the second part of the expansion. Audiogene will also evaluate the clinical safety, performance and ease of use of the delivery system developed by Sensorion.
About SENSE-501
SENS-501 (OTOF-GT) is an innovative gene therapy program developed to treat a specific form of congenital deafness associated with mutations in the OTOF (otoferlin) gene. This gene plays a key role in transmitting auditory signals between hair cells in the inner ear and the auditory nerve. When this gene is defective, individuals are born with severe to profound hearing loss.
The goal of SENS-501 (OTOF-GT) is to restore hearing by introducing a functional copy of the OTOF gene directly into hair cells via viral vector (AAV) technology. This treatment aims to restore the natural process of converting sound into electrical signals, enabling patients to regain their ability to hear.
Currently in the clinical research phase, this gene therapy program represents great hope for families affected by this rare form of genetic deafness. SENS-501 (OTOF-GT) embodies a commitment to scientific innovation in the field of hearing, with the potential to significantly improve the quality of life of patients with hereditary deafness.
This gene therapy for patients with otoferlin deficiency was developed within the framework of RHU AUDINNOVE, a consortium formed by Sensorion with the Necker Enfants Malades Hospital, the Pasteur Institute and the Fondation pour l'Audition. The project is partly funded by the French National Research Agency, through the Investment for the Future program (Ref: ANR-18-RHUS-0007).
About the sensor
Sensorion is a leading clinical-stage biotechnology company dedicated to developing novel therapeutics to restore, treat and prevent hearing loss disorders, a significant unmet global medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and pathogenesis of diseases associated with the inner ear, enabling it to select the best targets and mechanisms of action for drug candidates.
It has two gene therapy programs aimed at correcting monogenic hereditary forms of deafness, developed within the framework of its broad strategic collaboration focusing on the genetics of hearing with the Institut Pasteur. Currently in Phase 1/2 clinical trials, SENS-501 (OTOF-GT) targets deafness caused by mutations in the gene encoding otoferlin and GJB2-GT targets hearing loss associated with mutations in the GJB2 gene to address significant hearing loss. Sections in adults and children. The company is also working to identify biomarkers to improve diagnosis of these underserved diseases.
Sensorion's portfolio also includes clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders. Sensorion's clinical phase portfolio includes one Phase 2 product: SENS-401 (Arazasetron) which is progressing into a planned Phase 2 proof of concept clinical study of SENS-401 in cisplatin-induced ototoxicity (CIO), completed, with partner Cochlear Limited, in the SENS-401 study in patients scheduled for cochlear implantation. A phase 2 study of SENS-401 in sudden sensorineural hearing loss (SSNHL) was also completed in January 2022.
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Disclaimer
This press release contains certain forward-looking statements relating to Sensorion and its business. Such forward-looking statements are based on assumptions that Sensorion considers reasonable. However, there can be no assurance that such forward-looking statements will be verified, and are subject to numerous risks, including the risks set forth in our 2023 full year report published on March 14, 2024, which is available on our website and on our website. Evolving economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks that Sensorion does not yet know or that Sensorion does not currently consider to be material. The occurrence of all or part of these risks could cause the actual results, financial conditions, performance or achievements of Sensorion to differ materially from these forward-looking statements. This press release and the information it contains does not constitute an offer to sell or subscribe for, or a solicitation of an offer to buy or subscribe for, Sensorion shares in any country. Publication of this press release in some countries may constitute a violation of local laws and regulations. Any recipients of this press release must be aware of and comply with any such local restrictions.
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