Wellbeing Digital Sciences Inc. (“Wellbeing” or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA: SQ2), an evidence-based mental healthcare company focused on the development and implementation of innovative clinical solutions, including psychedelic medicine and digital therapeutics as supported by clinical research, announces that its wholly owned subsidiary KGK Sciences Inc. (“KGK”), today announced that the Company has completed the CMC package to be used in support 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 produced 1.5 mg psilocybin microdose capsules. These capsules were produced according to defined manufacturing processes and product specifications as outlined in chemistry, manufacturing, and controls (CMC) published guidelines.
The package to be submitted to Health Canada for approval includes:
- Phase 2 manufacturing process file for psilocybin active pharmaceutical ingredient (API).
- Finished product batch manufacturing records that confirms final capsule batch has been produced.
- Psilocybin capsule dissolution parameters that meet regulatory requirements.
“This is certainly an exciting time for KGK Science and our Client as we finalize the clinical trial application that will be submitted to Health Canada for approval of a Phase 2A study evaluation psilocybin microdose therapy for fragile X syndrome, the leading cause of autism spectrum disorder (ASD),” commented Najla Guthrie, CEO of Wellbeing Digital & KGK Science.
“KGK is a leading contract research organization (CRO), offering high-quality clinical research trials and expert regulatory support. We are pleased to be working with the Company in this venture. Furthermore, NOVA is excited to initiate the availability of its 1.5 mg psilocybin capsules to doctors, clinics and pharmaceutical companies in Canada for its potential therapeutic use in non-ASD clinical trials, including but not limited to diabetes, heart disease, epileptic conditions and post-traumatic stress disorder (PTSD),” added Will Rascan, President & CEO of Nova Mentis.
ABOUT KGK SCIENCE
Subsidiary of Wellbeing Digital Sciences, KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging health care products. Founded in 1997, the business has successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. Furthermore, the company has produced over 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database and collected 10 million data points. For additional information, please visit kgkscience.com.
ABOUT WELLBEING DIGITAL SCIENCES
Wellbeing Digital Sciences Inc. is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical treatment solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research. Its mission is supported by a network of North American clinics that provide forward-thinking therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trials services to clients pursuing drug development. For additional information, please visit wellbeingdigital.co.
ABOUT NOVA MENTIS LIFE SCIENCE CORP.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Nova is the first biotech company to achieve orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of Fragile X Syndrome (FXS). Our goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS. For further information on the Company, please visit www.novamentis.ca or email email@example.com.
On behalf of:
Chief Executive Officer
WELLBEING DIGITAL SCIENCES
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