Out of 105 patients were enrolled and treated in Sensorion’s SENS-111 Phase 2 trial, the last patient’s last visit of the study took place on October 15th.
MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News:
Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biopharmaceutical company which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo, today announced the last patient’s last visit in its Phase 2 clinical trial for SENS-111 investigated for the potential treatment of Acute Unilateral Vestibulopathy (AUV).
“We are pleased to announce that 105 patients were enrolled and treated in our SENS-111 Phase 2 trial. The last patient’s last visit of the study took place on October 15th. We remain on track for topline data readout in Q4 2019,” said Nawal Ouzren CEO of Sensorion.
The objective of this proof of concept phase 2, multi-centered, randomized, double-blind, placebo-controlled study is to determine the efficacy of SENS-111 in patients with acute unilateral vestibulopathy. Participants were treated for four days with either one of the two doses of SENS-111 or placebo and followed up to 28 days after the start of treatment. The primary endpoint is vertigo intensity measured using a visual analogic scale and the objective is to achieve 20% improvement versus placebo. A total of 105 patients were included in Europe, Israel, South Korea and the United States.