Successful Clinical Results Announced on Unigen’s Novel Immune Support Ingredient with Mushroom Formulation
Vancouver, British Columbia-May 3, 2023: Wellbeing Digital Sciences Inc. (“Wellbeing” or the “Company”), 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 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”
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 PhytoLogix® high-throughput screening 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 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.
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