Wellbeing Subsidiary KGK Science Receives Institutional Review Board Approval

Rhea-AI Summary

Wellbeing Digital Sciences Inc. (KONEF, NMLSF) has announced that its subsidiary, KGK Sciences Inc., gained IRB approval in Canada to conduct a groundbreaking Phase IIA clinical trial. This study will test the efficacy of psilocybin on adults with fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD). The trial is part of a partnership with Nova Mentis Life Science Corp., aiming to assess psilocybin's impact on cognitive and behavioral symptoms. Patient recruitment is expected to begin this year. Notably, Health Canada has granted special permission for participants to take the drug home, marking a significant milestone in clinical research. This trial supports Nova's ongoing efforts to improve treatment options for FXS patients, following their FDA Orphan Drug designation received in 2021.

Positive

• KGK Sciences received IRB approval to conduct a Phase IIA clinical trial on psilocybin for FXS.
• The partnership with Nova Mentis aims to assess psilocybin's impact on autism-related symptoms.
• Health Canada granted a No Objection Letter and a section 56 exemption facilitating controlled substance prescriptions.

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 received institutional review board (IRB) approval in Canada, on behalf of client Nova Mentis Life Science Corp. (“Nova Mentis” or the “Client”) (CSE:NOVA, OTC:NMLSF, FRA:HN3Q) allowing KGK to begin its human study testing the efficacy of psilocybin on adults diagnosed with 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 the first-ever Phase IIA clinical trial 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 studies,” commented Najla Guthrie, CEO of Wellbeing and KGK. “We look forward contributing to the science and alongside Nova Mentis.”

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 autism behaviour spectrum symptoms associated with Fragile X Syndrome. The results of the 10-person, open-label study will be used to support Nova’s 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 this year. 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. In addition, the Company received a section 56 exemption in February of this year, enabling an approved medical professional to prescribe select controlled substances without legal consequence, in order to better treat people with otherwise treatment-resistant conditions.

“Our team has been methodically achieving the necessary approvals and clinical planning to initiate this important study that supports Nova’s mission to improve the quality of life for people with autism and fragile X,” stated Dr. Marvin S. Hausman MD, Chairman of Nova Mentis’ Scientific Advisory Board. “This approval further validates our high standards of ethical and clinical practice and is a significant clinical milestone for this study.”

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/20230411005484/en/

Natalie Dolphin

VP of Marketing & Investment Relations

Email: ir@wellbeingdigital.co

Twitter: @Wellbeing_IR

Source: Wellbeing Digital Sciences Inc.

FAQ

What is the recent approval received by Wellbeing Digital Sciences regarding psilocybin?

Wellbeing Digital Sciences' subsidiary, KGK Sciences, received IRB approval to conduct a Phase IIA clinical trial testing psilocybin on adults with fragile X syndrome.

How does the clinical trial relate to Nova Mentis Life Science Corp.?

The clinical trial is a partnership with Nova Mentis to assess the effects of microdose psilocybin on cognitive and behavioral symptoms associated with fragile X syndrome.

When is patient recruitment expected to begin for the psilocybin trial?

Patient recruitment for the trial is expected to begin in the current year.

What special permissions were granted by Health Canada for this clinical trial?

Health Canada granted a No Objection Letter and a section 56 exemption, allowing participants to take home psilocybin for dosing.

What is the significance of the FDA Orphan Drug designation for Nova Mentis?

The FDA Orphan Drug designation received by Nova Mentis supports its drug development program for psilocybin in treating fragile X syndrome.