Sensorion has received approval from the European network of the Heads of the National Competent Authorities, Heads of Medicines Agencies (HMA), to begin a Phase ll clinical trial of SENS-401 for the treatment of sudden sensorineural hearing loss (SSNHL) in adults.
The approval is based on a voluntary harmonisation procedure (VHP) application submitted by Sensorion.
As part of the randomised, double-blind, placebo-controlled trial, Sensorion aims to enrol around 260 patients across 50 sites in Europe, the US, Canada, Israel, and Turkey.
Berlin Charité Medical University’s UKB Department of Otorhinolaryngology professor and chairman Dr Arne Ernst is the principal investigator of the trial, which is expected to begin in the last quarter of this year and plans to release interim top-line data next year.
Sensorion CEO Nawal Ouzren said: “Currently there are no treatments available for patients with SSNHL.
“Our second VHP approval demonstrates our team’s capacity to successfully bring drug candidates to the clinical development stage, and advance the development of therapies for patients with debilitating inner ear disorders.”
SENS-401 is currently being investigated as a potential treatment for the protection and preservation of inner ear tissue when lesions are present that can cause progressive or sequela hearing impediments.
The drug, which can be taken orally or via an injection, previously received orphan drug designation in Europe for the treatment of sudden sensorineural hearing loss.
It also received orphan drug designation from the US Food and Drug Administration (FDA) for the prevention of platinum-induced ototoxicity in paediatric patients.