Wellbeing Subsidiary KGK Science Receives Exemption Under Section 56 of the Controlled Drugs and Substances Act to Begin Psilocybin Clinical Trial

Rhea-AI Summary

Wellbeing Digital Sciences Inc. (KONEF, NMLSF) announces its subsidiary, KGK Sciences, has received a Section 56 exemption to proceed with a Phase IIA clinical trial evaluating microdose psilocybin therapy for fragile X syndrome (FXS). This trial aims to study cognitive and behavioral symptoms linked to FXS, a major genetic cause of autism spectrum disorder. The study is significant as it represents a pioneering approach in this area, supported by a No Objection Letter from Health Canada. With the production of cGMP synthetic psilocybin underway, the trial seeks to enhance understanding of psilocybin's therapeutic potential, with participant recruitment starting in early 2023.

Positive

• Received Section 56 exemption enabling progression to Phase IIA clinical trial.
• Trial focuses on unstudied effects of microdose psilocybin for fragile X syndrome, addressing a significant medical need.
• Successful production of cGMP synthetic psilocybin, crucial for advancing drug development.

Negative

• None.

A section 56 exemption can enable an approved medical professional to prescribe select controlled substances without legal consequence, in order to better treat people with otherwise treatment-resistant conditions.

VANCOUVER, British Columbia--(BUSINESS WIRE)-- 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”), has received an exemption under Section 56 of the Controlled Drugs and Substances Act, on behalf of client Nova Mentis Life Science Corp. (“Nova Mentis” or the “Client”) (CSE:NOVA, OTC:NMLSF, FRA:HN3Q) allowing KGK to proceed with the first-ever Phase IIA clinical trial assessing repetitive, oral microdose psilocybin therapy for fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD).

“KGK Science is thrilled to have received all of the regulatory approvals required to conduct this cutting-edge clinical trial. We believe that this study will be an impactful assessment of the potential of psilocybin in a disorder that truly affects the lives of many families and that has not yet been studied,” commented Najla Guthrie, CEO of Wellbeing and KGK. “We look forward to working with Nova Mentis and contributing to the science.”

KGK Science and Nova Mentis have partnered to conduct a pioneering first clinical trial to investigate the effects of microdose psilocybin on the cognitive and behavioural symptoms associated with fragile X syndrome. The results of the 10-person, open-label study will be used to support Nova Mentis’ drug development program under FDA Orphan Drug designation, which was received in late 2021. The trial will be led by KGK Science and recruiting efforts are expected to begin in early 2023. The clinical trial received a No Objection Letter from Health Canada in December of 2023 and is one of the first approved studies that will permit participants to take home the drug for dosing every other day.

Nova Mentis has completed production of pharmaceutical grade cGMP synthetic psilocybin 1.5 mg microdose capsules that will be used to advance the necessary research and development steps needed for successful drug regulatory approval and future commercialization.

“Securing this latest regulatory approval from the Canadian government is a critical step in Nova Mentis’ research and drug development program and allows us to begin our groundbreaking clinical trial. 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,” stated William 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

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 info@novamentis.ca.

On behalf of:
Najla Guthrie
Chief Executive Officer
WELLBEING DIGITAL SCIENCES

Notice Regarding Forward-Looking Information:

This news release contains forward-looking statements including but not limited to statements regarding the Company’s business, assets or investments, as well other statements that are not historical facts. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company.

The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made, by third parties in respect of the matters discussed above.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230214005176/en/

Natalie Dolphin

VP of Marketing & Investment Relations

Email: ir@wellbeingdigital.co

Twitter: @Wellbeing_IR

Source: Wellbeing Digital Sciences Inc.

FAQ

What is the purpose of Wellbeing Digital Sciences' clinical trial for fragile X syndrome?

The trial aims to study the effects of microdose psilocybin therapy on cognitive and behavioral symptoms associated with fragile X syndrome.

When will the clinical trial by KGK Sciences begin recruiting participants?

Recruiting efforts for the clinical trial are expected to begin in early 2023.

What regulatory approval did KGK Sciences receive for the psilocybin trial?

KGK Sciences received a Section 56 exemption and a No Objection Letter from Health Canada.

What is the significance of the Phase IIA trial for Nova Mentis Life Science Corp.?

This trial is vital as it investigates a novel treatment approach for fragile X syndrome, a condition with significant unmet medical needs.

What is the stock symbol for Wellbeing Digital Sciences?

The stock symbol for Wellbeing Digital Sciences is KONEF on the OTC market.