Policy & Regulation
Sensorion fails to meet primary endpoint in phase 2b proof-of-concept Seliforant trial
3 December 2019 -

France-based Sensorion's Seliforant has failed to meet the primary endpoint in the phase 2b proof-of-concept trial intended to treat acute unilateral vestibulopathy (AUV), it was reported yesterday.

The product is an orally available small molecule histamine type four receptor antagonist, which delivers an inhibitory effect on vestibular neuron activity. According to the company, the product was safe and well tolerated, but did not achieve the primary endpoint of vertigo intensity. The primary endpoint was measured by the area under the curve of the vertigo intensity visual analogue scale in standing position during the four treatment days, with eight post baseline evaluations.

The randomised, double-blind, placebo-controlled study included three parallel arms and evaluated the efficacy and safety of SENS-111 histamine H4 receptor antagonist. The company hired 105 patients in the phase 2b trial at the centres in Europe, Israel, South Korea and the US with a 1:1:1 randomisation ratio. The patients were stratified by duration of vertigo before treatment.