VANCOUVER, British Columbia–(Organization WIRE)– Wellbeing Digital Sciences Inc. (“Wellbeing” or the “Enterprise”) (NEO: MEDI) (OTC: KONEF) (FRA: SQ2), an proof-primarily based mental healthcare organization focused on the improvement and implementation of revolutionary clinical options, like psychedelic medicine and digital therapeutics as supported by clinical investigation, announces that its wholly owned subsidiary KGK Sciences Inc. (“KGK”), now announced that the Enterprise has completed the CMC package to be utilised in assistance of a phase 2A microdose psilocybin fragile X syndrome clinical trial for its client Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Client”).
Nova has developed 1.five mg psilocybin microdose capsules. These capsules have been developed according to defined manufacturing processes and solution specifications as outlined in chemistry, manufacturing, and controls (CMC) published recommendations.
The package to be submitted to Overall health Canada for approval contains:
– Phase two manufacturing approach file for psilocybin active pharmaceutical ingredient (API).
– Completed solution batch manufacturing records that confirms final capsule batch has been developed.
– Psilocybin capsule dissolution parameters that meet regulatory specifications.
“This is undoubtedly an fascinating time for KGK Science and our Client as we finalize the clinical trial application that will be submitted to Overall health Canada for approval of a Phase 2A study evaluation psilocybin microdose therapy for fragile X syndrome, the top lead to of autism spectrum disorder (ASD),” commented Najla Guthrie, CEO of Wellbeing Digital & KGK Science.
“KGK is a top contract investigation organization (CRO), supplying higher-top quality clinical investigation trials and specialist regulatory assistance. We are pleased to be functioning with the Enterprise in this venture. Additionally, NOVA is excited to initiate the availability of its 1.five mg psilocybin capsules to physicians, clinics and pharmaceutical firms in Canada for its possible therapeutic use in non-ASD clinical trials, like but not restricted to diabetes, heart illness, epileptic circumstances and post-traumatic tension disorder (PTSD),” added Will Rascan, President & CEO of Nova Mentis.
ABOUT KGK SCIENCE
Subsidiary of Wellbeing Digital Sciences, KGK is a top North American contract investigation organization primarily based in London, Ontario that mainly delivers higher-top quality clinical investigation trials with a concentrate on nutraceutical and emerging well being care goods. Founded in 1997, the organization has effectively helped hundreds of firms with custom made clinical trials and claim substantiation techniques to move goods into worldwide markets. KGK’s other current service lines incorporate specialist regulatory assistance and compliance options, participant recruitment, investigation assistance solutions and consulting solutions. Additionally, the organization has developed more than 150 publications, executed more than 400 clinical trials across additional than 40 indications, amassed 25,000 participants in its database and collected ten million information points. For further facts, please stop by kgkscience.com.
ABOUT WELLBEING DIGITAL SCIENCES
Wellbeing Digital Sciences Inc. is an proof-primarily based mental healthcare organization focused on the improvement and implementation of revolutionary clinical therapy options, like psychedelic medicine and digital therapeutics, as supported by clinical investigation. Its mission is supported by a network of North American clinics that offer forward-considering therapies and other sorts of therapy to sufferers as nicely as via a contract investigation organization that delivers clinical trials solutions to customers pursuing drug improvement. For further facts, please stop by wellbeingdigital.co.
ABOUT NOVA MENTIS LIFE SCIENCE CORP.
Nova Mentis Life Science Corp. is a Canadian-primarily based biotechnology organization and worldwide leader in establishing diagnostics and psilocybin-primarily based therapeutics for neuroinflammatory issues. Nova is the initial biotech organization to obtain orphan drug designation in each the United States and European Union for the use of psilocybin in the therapy of Fragile X Syndrome (FXS). Our purpose is to diagnose and treat debilitating chronic circumstances that have unmet healthcare wants, such as autism spectrum disorder (ASD) and FXS. For additional facts on the Enterprise, please stop by www.novamentis.ca or e-mail information@novamentis.ca.
On behalf of:
Najla Guthrie
Chief Executive Officer
WELLBEING DIGITAL SCIENCES
Notice With regards to Forward-Hunting Info:
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