Clinical Trials

Paragon Bioscience’s clinical biopharma spin-out, Emalex Bioscience, has announced that its lead candidate for the treatment of Tourette syndrome has met its primary and secondary endpoints in a recent phase 3 study.

The treatment, known as ecopipam, is a novel adopamine-1receptor antagonist. The study included 167 paediatric patients and 29 adult subjects enrolled at study sites across the EU and in Canada and the US. The primary endpoint was an increase in the time for paediatric subjects to have a relapse in symptoms following the taking of ecopipam or placebo, while the secondary endpoint was the same time to relapse in both paediatric and adult patients.

Tourette syndrome is a neurodevelopmental disorder most commonly characterised by vocal and motor tics. It can have a significant impact on the day-to-day lives of people with the condition, as well as have higher associated risks of mortality and morbidity.

Chief medical officer at Emalex Biosciences, Frederick Munschauer MD, stated: “These results strengthen our confidence in ecopipam as a potential first-in-class treatment for patients with Tourette syndrome. The topline data from our large, multinational, randomised withdrawal study show a statistically significant benefit for ecopipam in maintaining clinically meaningful reductions in vocal and motor tics for paediatric subjects with Tourette syndrome as compared to placebo.”

“The Emalex team worked closely with physician investigators and patient advocates throughout the drug development process and we are hopeful that ecopipam can provide symptomatic relief from the tics suffered by patients with Tourette syndrome. We’re entering a new era of progress for people with central nervous system conditions with limited or no treatment options and we look forward to developing innovative new options for them,” added Eric Messner, Emalex Biosciences CEO.