Wellbeing Subsidiary KGK Science Begins Recruitment in First-of-its-Kind Health Canada Approved Psilocybin Trial

Rhea-AI Summary

Wellbeing Digital Sciences Inc. (OTC: KONEF) announces the recruitment of participants for a pioneering clinical trial examining the effects of psilocybin on adults with fragile X syndrome (FXS). Conducted by its subsidiary KGK Sciences, the 28-day Phase IIA study is the first authorized by Health Canada allowing take-home psilocybin dosing. The study, set to treat its first participant in Q2 2023, aims to evaluate the safety and efficacy of Nova Mentis’ psilocybin drug (NM-1001) in a controlled environment, using advanced diagnostic technologies. Preliminary results are expected later this year, highlighting significant potential for psilocybin therapy in addressing unmet medical needs related to FXS.

Positive

• Initiation of the first-ever clinical trial for psilocybin effects on fragile X syndrome.
• Health Canada approved study allows take-home dosing of psilocybin.
• Partnership with Nova Mentis supports innovative research in mental health.
• Advanced technologies like AI and biomarker diagnostics will be utilized.

Negative

• None.

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 begun recruiting participants, on behalf of client Nova Mentis Life Science Corp. (“Nova Mentis” or the “Client”) (CSE:NOVA, OTC:NMLSF, FRA:HN3Q) in the first-ever clinical trial investigating the effects of psilocybin on adults diagnosed with fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD).

The 28-day study will test the safety and efficacy of Nova Mentis’ proprietary psilocybin drug (NM-1001) for the treatment of FXS and is one of the first Health Canada approved studies allowing participants to take home psilocybin for dosing every other day. Nova Mentis and KGK have partnered to conduct the Phase IIA clinical trial, which is being carried out at the KGK facility in London, Ontario, Canada. This 10-person, open-label study will assess repetitive, oral microdose psilocybin therapy for FXS. KGK and Nova Mentis intend to confirm changes in behavioral symptoms with state-of-the-art diagnostic and therapeutic mRNA and serotonin biomarker technology, combined with machine learning artificial intelligence (AI).

“KGK Science is eager to begin testing the efficacy of microdosing psilocybin in this cutting-edge clinical trial. Although we’ve seen the potential of psilocybin therapy being applied effectively for many health indications, we believe this Phase IIA clinical trial stands to make a significant impact 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.

The Company anticipates treating their first participant in Q2 2023 and having preliminary results ready later this year.

For more information, please click here.

To express your interest in participating in this study, please complete this eligibility questionnaire.

If you have questions, email participate@kgkscience.com or call 1-833-858-8359.

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/20230418005833/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 the clinical trial announced by Wellbeing Digital Sciences?

The trial aims to investigate the effects of psilocybin on adults diagnosed with fragile X syndrome.

When does Wellbeing Digital Sciences expect to treat its first participant?

The company anticipates treating its first participant in Q2 2023.

What is the stock symbol for Wellbeing Digital Sciences?

The stock symbol for Wellbeing Digital Sciences is KONEF.

Who is conducting the clinical trial for psilocybin therapy?

The clinical trial is being conducted by KGK Sciences, a subsidiary of Wellbeing Digital Sciences.

What are the expected outcomes of the psilocybin clinical trial?

The trial aims to assess the safety and efficacy of the proprietary psilocybin drug (NM-1001) for treating fragile X syndrome.

What technology will be used in the psilocybin trial?

The trial will employ advanced diagnostic technologies, including AI and biomarker diagnostics.

What is the significance of this clinical trial for fragile X syndrome?

It represents a significant step towards developing effective treatments for a condition that has not been extensively studied.