French biotechnology company Sensorion has obtained the European Heads of Medicines Agencies (HMA) authorisation to start a Phase II trial of its SENS-111 for the treatment of acute severe vertigo through the Voluntary Harmonisation Procedure (VHP).
The VHP allows the firm to conduct the clinical trial with a single clinical protocol in all European Union (EU) countries.
SENS-111 is a small-molecule histamine type 4 receptor antagonist with a neuromodulation effect of the sensorineural inner-ear cell function.
The multi-centre, randomised, double-blind, placebo-controlled Phase II trial will evaluate the safety and efficacy of SENS-111 in 207 patients with acute unilateral vestibulopathy.
Sensorion chief executive officer Laurent Nguyen said: “We are delighted to benefit from the VHP, which is more efficient and allows us to meet the rigorous requirements of each country where we have trial sites, while also facilitating enforcement of our own exacting standards.
"Thanks to the VHP authorisation and our active investigational new drug (IND) in the US, we will be able to undertake this trial simultaneously in many of the world’s leading centres of excellence for the treatment of acute severe vertigo, thus enabling us to benefit from an optimal patient enrolment pace.”
The trial's primary endpoint is the measurement of intensity of the vertigo expressed, using a visual analog scale.
The Phase II trial also received authorisation from the US Food and Drug Administration (FDA) in September last year.
With the patient enrolment scheduled to commence during the first quarter of this year, the firm has partnered with various specialised centres in the US, Europe and South Korea.