Tag: DB-OTO gene therapy

The company highlights progress in its SENS-501 and GJB2-GT clinical programs, recent financing, and a leadership transition. Sensorion, a clinical-stage biotechnology company, provided a corporate update detailing advancements in its gene therapy pipeline for hearing loss disorders. Gene Therapy Pipeline Highlights The company's SENS-501 program, a gene therapy for hearing loss caused by otoferlin (OTOF) deficiency, received positive safety recommendations from the Data Monitoring Committee for its Phase 1/2 Audiogene clinical trial. Preliminary results from the trial’s two cohorts showed the therapy was well-tolerated in infants and toddlers aged 6 to 31 months, with early clinical efficacy signals observed. In the second cohort, two of three patients showed hearing threshold gains of approximately 60 and 70 dB HL at certain frequencies by the third month. Sensorion is also advancing its GJB2 gene therapy program, which targets pathologies related to GJB2 mutations, a leading cause of genetic congenital deafness. The program is on track for a Clinical Trial Application (CTA) filing in the first half of 2026 following discussions with US and European regulatory agencies. “Our GJB2 gene therapy program continued to advance toward CTA/IND submission, supported by regulatory interactions with the FDA and EMA, targeting the largest cause of genetic congenital deafness,” says Amit Munshi, chairman and interim chief executive officer of Sensorion, in a release. “On the financial side, we executed a successful financing totaling over €60 million, led by a strategic investment from Sanofi with participation from existing and new investors, strengthening our balance sheet and shareholder registry to finance the next steps of our gene therapy development.” SENS-401 and Corporate Updates For its small molecule candidate SENS-401 (Arazasetron), end-of-study data from the Phase IIa NOTOXIS trial for preventing Cisplatin-Induced Ototoxicity (CIO) confirmed a favorable safety profile. While the primary analysis showed comparable hearing threshold changes between arms, post hoc analyses suggested a potential benefit in patients exposed to the highest cumulative cisplatin doses. The company also announced leadership changes, with chairman of the board Amit Munshi assuming the role of interim chief executive officer in February 2026, following the departure of Nawal Ouzren. A search for a permanent chief executive officer has commenced. Featured image: Dreamstime

Tag: DB-OTO gene therapy

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Sensorion Provides Update on Hearing Loss Gene Therapies

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