French biotech company Sensorion is set to begin its Phase II clinical trial of SENS-111 to treat acute severe vertigo.
SENS-111 is the first-in-class histamine type 4 receptor antagonist class indicated to treat inner-ear pathologies.
It triggers a neuromodulation effect of the sensorineural inner ear cell function and is under development for the symptomatic treatment of vertigo crises or tinnitus.
SENS-111 is a small molecule that can be administered orally, as well as through a standard injection.
The Phase II international, multi-centre, randomised, double-blind and placebo-controlled study will be conducted to test the safety and efficacy of SENS-111 in 207 patients suffering from acute unilateral vestibulopathy.
The patients will be divided into three groups and will receive oral administration of either one of 100mg and 200mg of SENS-111 or placebo for four consecutive days.
The study is primarily focused on determining the effect of SENS-111 on the intensity of the vertigo as measured using a visual analog scale.
The secondary goals of the study will be to determine the effect of SENS-111 on the patient’s quality of life and the medium-term recovery of their vestibular function.
Sensorion CEO Laurent Nguyen said: “We are delighted to be able to launch a phase II clinical study of this size with SENS-111 that is a major first in acute severe vertigo.
“Our preclinical results and the activity signals observed in healthy volunteers during the phase Ib trial are enabling us to make rapid progress with this small orally active molecule that aims to treat this highly debilitating pathology, for which physicians lack effective and well-tolerated drugs.”