Wellbeing Digital Sciences (NEO:MEDI.AQN, OTCQB:KONEF) Inc, formerly known as Ketamine One, announced that its wholly-owned subsidiary, KGK Science Inc, has formed a tactical partnership with Nova Mentis Life Science Corp to help develop Nova’s psychedelic drug portfolio in Canada.
Nova is a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders. Both companies plan to jointly submit a clinical trial application (CTA) to Health Canada for a Phase 2A clinical study evaluating psilocybin microdose therapy for fragile X syndrome, the company said.
“Nova’s microdose approach aims to address an unmet need that promises to have a significant impact on the lives of families impacted by Fragile X Syndrome,” said Najla Guthrie, CEO of KGK in a statement.
“KGK is proud to be able to contribute and is confident our expertise will guide Nova to success through the orphan drug pathway.”
READ: KetamineOne changes name to Wellbeing Digital Science
Nova’s research and clinical team initially identified unique opportunities in psychedelic drug development and chose a classic drug development pathway involving careful planning and execution of chemistry, manufacturing, and preclinical proof of efficacy studies.
Nova is the first biotech company to achieve psilocybin orphan drug designation in both the United States and European Union. It has also manufactured a large supply of more than 98% pure psilocybin for clinical studies and commercialization after drug approval.
“Nova and KGK have synergistic capabilities that will facilitate submission of the CTA to Health Canada and achieve, in my opinion, no objection to this unprecedented clinical study,” said Marvin S. Hausman, Nova SAB chairman. “In our discussions with KGK, we realized early on that our two teams had the ability to navigate the entire lifecycle journey of our novel psilocybin microdose treatment of Fragile X Syndrome from a Phase 2A clinical study to drug approval and commercialization.”
KGK brings expertise in regulatory submission, managing Investigational New Drug enabling activities, clinical trial design and trial execution, established clinical sites, and in-house virtual behavioral testing models.
Contact Ritika at ritika@proactiveinvestors.com