A randomized, triple-blind, placebo-controlled clinical trial
involving supplementation with a bioflavonoid ingredient UP446
provides evidence for a robust, healthy immune response in healthy
adults following influenza vaccination.
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, announced today that a clinical
study conducted by its wholly owned subsidiary KGK Science Inc.
(“KGK”), has shown positive results of UP446 supplementation
in helping mount a robust immune response following influenza
vaccination.
UP446, a natural health ingredient developed by Unigen Inc.
(“Unigen”), contains Acacia catechu and Scutellaria baicalensis,
botanicals with antioxidant and anti-inflammatory properties;
however, this is the first study to examine these ingredients using
a human vaccine model. The randomized, triple-blind,
placebo-controlled clinical trial involving supplementation with
bioflavonoid composition UP446 provides evidence for a robust,
healthy immune response in adults following influenza
vaccination.
Healthy adult participants, who had not yet received their
influenza vaccine, between 40-80 years of age were randomized to
either UP446 or placebo for 56 days. Halfway through the study, at
day 28, participants received a flu vaccine. The results, published
in Journal of the American Nutrition Association, showed that
supplementation with UP446 significantly increased levels of IgA
and IgG antibodies compared to placebo in the post-vaccination
period. Influenza-specific IgG antibodies significantly increased
with UP446 supplementation from Day 28 to 56 and from baseline at
Day 56. Blood levels of glutathione peroxidase, part of the
antioxidant defense system, were significantly increased in the
pre-vaccination period suggesting UP446 may help improve
antioxidant functions in conjunction with vaccination.
“Conducting gold-standard clinical studies is critical in
furthering our understanding of the complex interactions between
natural health products and immune function” says Dr. Erin D.
Lewis, Scientific Director at KGK Science. “Using a vaccine model
provided a unique and novel way to examine the effect of UP446
supplementation on the immune response”.
Unigen president and CEO, Dr. Qi Jia, added “This study is a
critical step toward providing consumers with scientifically based
and safe ingredients and bringing natural health products to market
as immune defense nutrients to support respiratory health in cold
and flu season. This immune response plays an important role in a
comprehensive vaccination strategy that can be applied across the
entire spectrum of healthy population especially in an aging
community.”
Future research on UP446 is warranted, prior to expanding the
specific application of the ingredient, and will be undertaken to
understand the effect on other immune cell populations, and in
populations at increased risk of upper respiratory tract
infections, such as older adults, teachers, and individuals with
seasonal respiratory allergy.
ABOUT UNIGEN INC.
Unigen discovers, develops, and manufactures proprietary
natural-product active ingredients for dietary supplements,
cosmetic and personal care products, prescription medical food and
botanical drug products. The Company discovers its ingredients
through its high throughput screening PhytoLogix® approach applied
to a proprietary well-annotated collection of botanicals and a
legacy mining approach applied to botanicals having known medicinal
benefits.
Mechanism of action, safety and efficacy are documented with
extensive preclinical in vitro and in vivo testing and by human
clinical studies. Unigen protects its discoveries with issued
patents and patent filings in all major territories and
manufactures its products to GMP standards. Unigen commercializes
its proprietary ingredients through licensing and ingredient supply
alliances with commercial partners engaged in the manufacture,
distribution, and marketing of end-products in each of Unigen’s
target markets.
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.
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/20221206005150/en/
Natalie Dolphin VP of Marketing & Investment
Relations Email: ndolphin@wellbeingdigital.co Twitter:
@Wellbeing_IR
Kathy Markham Marketing Manager Unigen, Inc. Email:
kmarkham@uniogen.net Website: http://unigen.net
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