Health Canada Grant Waiver: Phase 2 Trial on Psilocybin for Genetic Disorders – Wellness Digital (OTC:KONEF), Nova Mantis Life Science (OTC:NMLSF)

Wellbeing Digital konf Assistant KGK Science will move forward with a first-ever Phase 2a clinical trial assessing repeatable, oral microdose psilocybin therapy for Fragile X syndrome (FXS), a genetic disorder.

KGK and its customers Nova Mantis nmlsf it is set to operate Leading Clinical Trials To study the effects of take-home microdose psilocybin on cognitive and behavioral symptoms associated with FXS.

Wellbeing Digital is exempt under section 56 of the Canadian Controlled Drugs and Substances Act (CDSA).

See also: Section 56(1) exemption takes effect today in British Columbia

KGK will lead the trial and utilize Nova’s recently completed API cGMP production of synthetic psilocybin 1.5mg microdose capsules.

Recruitment for the 10-person, open-label study is scheduled to begin in the first quarter of 2023. Results will be used to support NOVA drug development program Received in late 2021 under FDA orphan drug designation.

Nova President and CEO William Rasken says the latest regulatory approval from the Canadian government is “an important step forward” in the company’s research and drug development program.

“We are eager to begin recruiting participants as we seek to better understand the therapeutic potential of psilocybin in the treatment of fragile X syndrome,” he said.

On behalf of KGK, CEO Najla Guthrie The clinical trial is called a “state-of-the-art” study and the company says it will be “an impressive evaluation of the potential of psilocybin in a disorder that really affects the lives of many families and that has not yet been studied.” “

Photo: edit Benzinga with photos by Cytonn Photography on Pexels and Jynto on Wikimedia Commons.

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