Vancouver, British Columbia-November 17, 2022 – Nova Mentis Life Science Corp. (CSE: NOVA) (OTCQB: NMLSF) (FSE: HN3Q) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders is pleased to announce that it has entered into a research services agreement with KGK Sciences Inc. (KGK), a wholly owned subsidiary of Wellness Digital Science Inc., to conduct a planned Phase II A clinical trial to test the efficacy of psilocybin on patients diagnosed with fragile X syndrome (FXS).
“NOVA’s planned psilocybin treatment of FXS is a major drug development milestone for our company,” said William Rascan, President & CEO of Nova Mentis. “We are confident that KGK’s extensive experience in high-quality clinical research trials and expert regulatory support in the space will enable us to make considerable progress towards successful treatment of ASD and FXS, currently unmet medical needs.”
“We are thrilled to be working with Nova Mentis for their planned phase II A clinical trials to test the efficacy of psilocybin-based therapeutics for the treatment of behavioural and cognitive symptoms associated with FXS. Over the past 25 years, we have successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies that move products efficiently into the global markets,” commented Najla Guthrie, CEO of KGK.
The pioneering Phase II A clinical trial is the first human research investigating the potential of a microdose of psilocybin to improve behavioural and cognitive symptoms associated with FXS. The results of the 10-person, open-label study will be used to support NOVA’s drug development program under FDA Orphan Drug designation, which was received in late 2021. Under the research and services agreement with NOVA, KGK will perform research services, including the development of the clinical trial protocol, regulatory and ethics submissions, conduct of the trial, data management and validation, statistical analysis and drafting of the final report (“Services”). The clinical trial is planned to be conducted at KGK’s dedicated research facility in London, Ontario, Canada.