A randomized, triple-blind, placebo-controlled clinical trial
involving supplementation with UP360 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 UP360 supplementation
in helping mount a robust immune response following influenza
vaccination.
UP360, a naturally-derived health and wellness ingredient
developed by Unigen Inc. (“Unigen”), contains extracts from both
the Poria cocos mushroom and rosemary as well as Aloe vera gel
powder. The resultant proprietary blend of these botanical
ingredients in UP360 produces antioxidant, anti-inflammatory, and
immunomodulatory effects. This is the first study to examine a
proprietary combination of these ingredients using a human vaccine
model. The randomized, triple-blind, placebo-controlled clinical
trial involving supplementation with UP360 provides evidence for a
robust, healthy immune response in adults following influenza
vaccination.
Healthy adult participants between 40-80 years of age, who had
not yet received their influenza vaccine, were randomized to either
UP360 or placebo for 56 days. Halfway through the study, at day 28,
participants received a flu vaccine. The results, published in
Frontiers in Nutrition, showed that supplementation with UP360
significantly increased the percentage of TCR gamma-delta cells,
known to provide a first line of immune defense for mucosal
membranes, in the post-vaccination period compared to placebo.
Furthermore, participants supplemented with UP360 had significant
increases in blood levels of glutathione peroxidase – antioxidative
stress biomarker – and influenza B-specific IgG antibodies before
and after vaccination, respectively.
“UP360 supplementation provided a beneficial immune defense
response and improved antioxidant function in conjunction with
traditional vaccination, adopted by many as part of their overall
immune health strategy,” says Dr. Corey Hilmas, Chief Scientific
Affairs and Regulatory Officer at KGK Science. “Using a vaccine
model offered a unique strategy to evaluate the effect of UP360
oral administration on the immune response.”
Unigen President and CEO, Dr. Qi Jia, added, “This study is a
critical step toward providing consumers with immune support
products backed by rigorous science. Selectively promoting the cell
types responsible for mucosal immune responses can play an
important role to offer further support for the immune system in
those who have already received a flu vaccine. This strategy can be
applied across the entire spectrum of the healthy, vaccinated,
general population, particularly the elderly.”
Prior to expanding the specific application of UP360
ingredients, further research is warranted to better understand
efficacy among populations at greater risk of upper respiratory
tract infections, such as older adults, teachers, and individuals
with seasonal respiratory allergy, as well as the effect on other
clinically relevant immune cell populations.
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.
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/20230503005380/en/
On behalf of: Najla Guthrie Chief Executive Officer
WELLBEING DIGITAL SCIENCES For further information, please
contact: Natalie Dolphin VP of Marketing & Investment
Relations Email: ndolphin@wellbeingdigital.co Twitter:
@Wellbeing_IR Kathy Markham Marketing Manager Unigen, Inc.
Email: kmarkham@unigen.net Website: http://unigen.net
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