(AOF) – Sensorion, a pioneering clinical-stage biotechnology company dedicated to developing innovative therapies to restore, treat and prevent hearing loss, announces that it has submitted an initial Clinical Trial Authorization (CTA) application for OTOF -GT with the Medicines Healthcare products Regulatory (MHRA) UK Medicines Regulatory Agency (MHRA).
Phase 1/2 clinical trial (Audiogene) aims to evaluate the safety, tolerability and efficacy of intra-cochlear injection of OTOF-GT for the treatment of otoferlin gene-related hearing loss in patients up to 31 months of age.
The CTA’s submission follows extensive preclinical studies that assessed the safety and efficacy of OTOF-GT and the successful production of a batch of the gene therapy pharmaceutical product for the trial. clinical.
OTOF-GT, Sensorion’s dual-vector Adeno-Associated Gene Therapy (AAV) program is being developed to restore hearing to patients with otoferlin deficiency-related mutations with hearing loss severe to profound non-syndromic prelingual sensorineural neuroscience.
AOF – LEARN MORE
Find out more about the “pharmacy” sector
Loss of speed in European research
European research is losing ground to American and Chinese research. In twenty years, Europe’s share has fallen from 41% to 31% in global R&D. China’s share jumped from 1% to 8%. As for the United States, which supplanted Europe, in 2001 it devoted only 2 billion euros per year more than Europe to R&D, whereas now this gap has reached 25 billion! Some experts accuse the European authorities of not having deployed effective policies. The financing of pharmaceutical research should therefore have been better targeted via the “Horizon 2020” programme. France only comes in eighteenth position in European funding despite the quality of its research. Conversely, the United States concentrates funding on Boston and a few centers of excellence.