KGK Sciences receives approval for psilocybin clinical trial in Canada

KGK Sciences Inc. received a no objection letter from Health Canada to proceed with a phase 2a clinical trial evaluating the use of psilocybin for fragile X syndrome, the leading genetic cause of autism spectrum disorder.

According to a company press release, the results of a 10-person, open-label study will be used to support KGK’s client Nova Mentis’ drug development program under FDA orphan drug designation, which was received in late 2021. KGK will begin recruiting efforts for the phase 2a trial in early 2023.

Nova Mentis completed the production of pharmaceutical grade cGMP synthetic psilocybin 1.5 mg microdose capsules that will be used to advance necessary research and development steps needed for successful regulatory approval and commercialization.

“We are thrilled to receive approval for this pioneering phase 2a psilocybin clinical study for our client Nova Mentis,” KGK CEO Najla Guthrie said in the release.