The randomized, double-blind, placebo-controlled Phase 2 study will be conducted across 50 sites in Europe, the U.S., 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. Principal investigator is Prof. Dr. Arne Ernst, Professor and Chairman, Dept. Otorhinolaryngology at UKB, the teaching hospital of the Berlin Charité Medical University and the Alice Solomon Hochschule Clinical Centre, and Past/Honorary Chairman of the German Society of Audiology, Neurotology &Otology (ADANO), and EAONO (European Academy for Otology and Neurotology).
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 – multicenter, placebo-controlled Phase 2 trial in vertigo caused by acute unilateral vestibulopathy (AUV).
The VHP enables Sensorion to conduct its clinical trial in all European Union countries.
This procedure considerably simplifies 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 allows the trial to be conducted with a single clinical protocol in all European countries involved.
Sensorion CEO Nawal Ouzren said: “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.
“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.”
Source: Company Press Release