MONTPELLIER, France, March 18, 2026 — Sensorion reported strong pipeline and corporate progress in its 2025 full-year update, highlighting continued advancement of its AAV-based gene therapy programs targeting hereditary hearing loss, alongside strengthened financial positioning following a €60 million financing round led in part by Sanofi.
The company’s GJB2 gene therapy program (SENS-601) is progressing through CTA/IND-enabling studies and remains on track for clinical trial application submission in the first half of 2026. The program, developed in collaboration with Institut Pasteur, targets mutations in the GJB2 gene—the leading cause of autosomal recessive congenital deafness, accounting for approximately 50% of cases. Regulatory interactions with both the U.S. Food and Drug Administration and the European Medicines Agency since Q3 2025 have supported the program’s advancement toward first-in-human studies.
In parallel, Sensorion continues to advance SENS-501, a dual AAV gene therapy designed to restore hearing in patients with mutations in the OTOF gene. The ongoing Phase 1/2 Audiogene trial is evaluating intracochlear administration of the therapy in infants and toddlers aged 6 to 31 months. Early clinical data have shown the therapy to be well tolerated, with no serious adverse events reported, alongside encouraging preliminary efficacy signals, including improvements in auditory brainstem response (ABR) and pure-tone audiometry (PTA).
Following completion of Cohort 1, the study advanced into Cohort 2, where early directional improvements were observed. Two of three treated patients demonstrated hearing threshold gains of approximately 60–70 dB HL at select frequencies by Month 3. Sensorion expects to report six-month efficacy data in Q1 2026, which will further inform dose selection and clinical development strategy.
Both SENS-501 and GJB2-GT leverage AAV (adeno-associated virus) vectors to deliver functional copies of defective genes directly to inner ear cells, aiming to restore the biological processes required for hearing. These approaches represent a growing trend in applying gene therapy to sensory disorders, where localized delivery and early intervention may offer meaningful functional recovery.
Beyond gene therapy, Sensorion is also advancing SENS-401 (Arazasetron), a small molecule designed to protect inner ear tissue. The program has completed multiple Phase 2 studies, including in cisplatin-induced ototoxicity, where safety was confirmed and subgroup analyses suggested potential benefit in patients receiving higher cumulative chemotherapy doses.
Financially, the company strengthened its position through a €60 million financing round in January 2026, including a €20 million strategic investment from Sanofi. This extends Sensorion’s cash runway into the first half of 2027, supporting continued clinical development and upcoming regulatory milestones.
With multiple programs advancing toward the clinic and key data readouts expected in 2026, Sensorion is positioning itself at the forefront of genetic hearing loss therapeutics, an area with significant unmet medical need and no currently approved gene therapies targeting GJB2 mutations.
