Wellbeing Subsidiary KGK Science Receives Exemption Under Section 56 of the Controlled Drugs and Substances Act to Begin Psilocybin Clinical Trial
February 14 2023 - 8:30AM
Business Wire
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.
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.
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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
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