Wellbeing Subsidiary KGK Science Begins Recruitment in First-of-its-Kind Health Canada Approved Psilocybin Trial
April 18 2023 - 8:30AM
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.
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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
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