Sensorion has reported positive topline results from the SENS-111-202 study after the trial met its primary endpoint of tolerability.
The SENS-111-202 study is designed to evaluate the safety and pharmacodynamic effects of Seliforant (SENS-111) for the treatment of experimentally evoked vestibular imbalance.
As part of the randomised, double-blind, placebo-controlled and Meclizine-calibrated crossover trial, Sensorion randomised 32 subjects to receive a dose of each of the four-treatment regimens, with a week between every treatment.
The treatments were Seliforant 100mg, Seliforant 200mg, Meclizine 50mg and a placebo.
The trial was carried out in the Netherlands, with repeated objective psychometric measures of vigilance and cognitive performance being the primary objectives.
The new topline results showed that Seliforant did not affect vigilance and cognitive performance during a motion stimulus.
The study showed that compared with Meclizine, Seliforant did not have any negative central nervous system (CNS) side effects including sedation, impairment of memory and cognitive performance.
Meclizine is a type of histamine H1 receptor antagonist, which is used as the first line of treatment in acute vertigo and motion sickness in the US. The drug has a sedative effect that stops the patient from functioning during treatment of the vertigo attack.
Sensorion CEO Nawal Ouzren said: “This significant achievement in the development of Seliforant adds to the evidence that Seliforant has the potential to become a new key drug in the treatment of acute vertigo with a robust safety profile compared to current standard of care.
“The next milestone is the Phase ll proof of concept (POC) efficacy trial readout in AUV in H2 2019.”
Sensorion’s Seliforant is an investigational histamine type 4 receptor antagonist class that aims to target the symptomatic treatment of vertigo crises.