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The partnership between contract research organization KGK Sciences Inc. and Nova Mentis Life Science Corp. NMLSF has started recruiting participants for the first-ever clinical trial assessing the effects of psilocybin in adults diagnosed with Fragile X Syndrome (FXS), the leading genetic cause of autism spectrum disorder.
Taking place at KGK’s London facility in Ontario, Canada, the 28-day Phase 2a study will test the safety and efficacy of repetitive oral microdoses (1.5 milligrams) of Nova’s synthetic psilocybin NM-1001 on the cognitive and behavioral symptoms commonly seen in people with FXS diagnosis.
Changes in the 10 participants will be measured through diagnostic and therapeutic mRNA and serotonin biomarker technology together with machine-learning artificial intelligence, or AI.
See Also: Cannabinoids & Autism — A Baltimore Company Is On Track To Start Phase 2 Clinical Trial For New Treatment
The study aims for an unusually tested health condition and, so far, is one of the sole take-home psilocybin trials to have received Health Canada’s approval.
KGK’s CEO Najla Guthrie says this trial is expected to make “a significant impact” in FXS, a disorder that “truly affects the lives of many families and that has not yet been studied.”
Dr. Marvin S. Hausman, scientific advisory board chairman of Nova, says the study builds on “very positive” preclinical results of psilocybin as a potential new treatment for symptoms associated with autism, “the fastest-growing developmental disability in the world.”
The companies anticipate dosing will begin in the second quarter of this year, with preliminary results following suit.
Photo: Benzinga edit with photo by Susie Hedberg and C4289N on Shutterstock.
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