Cambridge, Mass. — Sensorion said it has advanced its lead gene therapy program for hereditary hearing loss while reporting a wider net loss for the first half of 2026.
The clinical-stage biotechnology company said it filed Clinical Trial Applications in France and Canada for SENS-601, its gene therapy candidate for GJB2-related hearing loss. French regulators subsequently authorized the company to begin the Phase I/II HearConnex clinical trial.
Sensorion expects to submit an Investigational New Drug application in the United States and a Clinical Trial Application in Australia by the end of 2026. Dosing of the first patient in HearConnex is targeted for early 2027.
SENS-601 is a single-vector AAV-based gene therapy designed to restore hearing in patients with mutations in the GJB2 gene. The company is initially focusing development on pediatric congenital deafness. The therapy is designed to be delivered through a single intracochlear injection.
“I am delighted to have joined Sensorion at such an exciting time, as SENS-601 enters the clinic,” said Fred Chereau, Chief Executive Officer of Sensorion.
The HearConnex study is designed as a two-part, open-label trial. The first part will evaluate the safety and tolerability of SENS-601 following unilateral intracochlear injection across two ascending-dose groups, while the second will evaluate efficacy following bilateral administration at the selected dose.
Sensorion also said it discontinued further clinical development of SENS-501, its gene therapy program for otoferlin-mediated hearing loss, to concentrate resources on SENS-601.
For the first half of 2026, research and development expenses rose 9% to €16.4 million from €15 million a year earlier, while general and administrative expenses increased to €7.7 million from €4.1 million. Net loss widened to €20.7 million from €16 million.
Sensorion reported €88 million in cash, cash equivalents and short-term deposits as of June 30, 2026, and said its current resources are expected to fund operations through the end of 2027.
