Health Canada has approved Neuren Pharmaceuticals' (ASX:NEU) clinical trial application for the Koala Phase 3 clinical trial evaluating NNZ-2591 for the treatment of Phelan-McDermid syndrome in children aged three to 12 years, clearing the way for the inclusion of clinical trial sites in Canada.
The Melbourne-based company said the trial had already received Investigational New Drug approval from the US Food and Drug Administration, with enrolment underway, and confirmed that a second US site in California has now been activated and is enrolling participants.
Neuren CEO Jon Pilcher said the approval marked a further regulatory milestone for the first ever Phase 3 trial in PMS, adding that the company looked forward to working with investigators and the PMS community in Canada while continuing to expand enrolment across both the east and west coasts of the United States.
At the time of reporting, Neuren Pharmaceuticals' share price was $20.04.