Sensorion (FR0012596468 – ALSEN), a biotech company specializing in the treatment of inner ear diseases, announced that the Heads of Medicines Agencies (HMA)—a European network of the Heads of the National Competent Authorities—approved the company’s Volunturary Harmonization Procedure (VHP) application to initiate a Phase 2 clinical trial for SENS-401 in the treatment of sudden sensorineural hearing loss (SSNHL) in adults.
The randomized, double-blind, placebo-controlled Phase 2 study will be conducted across 50 sites in Europe, the US, Canada, Israel, and Turkey, and enroll approximately 260 patients. The Company aims for a study start (first patient in) in Q4 2018, and interim topline data in Q4 2019. The principal investigator is Dr Arne Ernst, professor and chairman, otorhinolaryngology department, at UKB, the teaching hospital of the Berlin Charité Medical University and the Alice Salomon Hochschule (ASH) Clinical Centre.
SENS-401 has received Orphan Drug Designation in Europe for the treatment of SSNHL, and for platinum-induced ototoxicity in pediatric populations in the US.
SENS-401 is Sensorion’s second product candidate to enter Phase 2 for orally-delivered treatment of inner ear diseases. SENS-111, the Company’s first product, is currently evaluated in an international, multi-center, placebo-controlled Phase 2 trial in vertigo caused by acute unilateral vestibulopathy (AUV).
The VHP reportedly enables Sensorion to conduct its clinical trial in all European Union countries. This procedure is said to considerably simplify the trial’s organization, because a single country’s competent authority coordinates requests and interactions between national drug agencies and Sensorion, and issues a joint opinion. Importantly, the VHP reportedly allows the trial to be conducted with a single clinical protocol in all European countries.
“We are excited to be moving SENS-401 to the next stage of clinical development as a potential first in-class therapy for the treatment of sudden sensorineural hearing loss. Currently there are no treatments available for patients with SSNHL,” said Nawal Ouzren, Sensorion’s CEO. “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.”