Elysium Health™ Announces Positive Results on Its Product Basis™ Published in Hepatology
Reduces Markers of Hepatic Inflammation in Non-Alcoholic Fatty Liver Disease (NAFLD)
NEW YORK, Oct. 12, 2022 /PRNewswire/ -- Elysium Health, Inc.™, a leading life sciences company focused on aging research, today announced that the detailed results from its clinical trial on Basis™ (NRPT) in people with non-alcoholic fatty liver disease (NAFLD) were published in Hepatology. The trial studied the effects of Basis on liver health, including accumulation of fat on the liver and markers of inflammation, in men and women with NAFLD, a condition that is estimated to affect up to 100 million Americans. The recommended dose of Basis (NRPT 1X) was shown to reduce multiple markers of liver inflammation: a decrease in the circulating levels of the liver enzymes alanine transferase (ALT) and gamma-glutamyl transferase (GGT) was observed in this group, and this decrease was significant with respect to placebo. Furthermore, a significant decrease in the circulating levels of the toxic lipid, ceramide 14:0, was also observed in the recommended dose group versus placebo, and this decrease was associated with an improvement in ALT in individuals of the same group. The study also further confirmed that Basis is safe and well tolerated in healthy individuals.
"The improvements in markers of liver health observed in Elysium Health's study are very encouraging," said Stephen Harrison, M.D., a co-author on the study and medical director of Pinnacle Clinical Research. "The magnitude of the reduction in the liver enzymes ALT and GGT observed in the study, as well as the reduction in the toxic lipid ceramide 14:0, indicates that NRPT (Basis) supports liver health and has potential to improve outcomes in people with NAFLD. Accordingly, NRPT warrants further study as a potential intervention to treat both NAFLD and more serious liver conditions such as nonalcoholic steatohepatitis (NASH), whether on its own or as a complement to another treatment."
While NAFLD is not classified as a disease, the current obesity epidemic is paralleled by manifestations of metabolic syndrome, such as insulin resistance, elevated blood pressure, increased waist circumference, and hypertriglyceridemia. All of these biomarkers are also conditions that are associated with excessive accumulation of liver fat, indicating that fatty liver may be regarded as the hepatic manifestation of metabolic syndrome.
"Fatty liver disease is an underrecognized epidemic in the U.S. and many other nations, largely related to poor diet," said Dariush Mozaffarian, M.D., a co-author on the study and Jean Mayer Professor at the Tufts Friedman School of Nutrition Science and Policy, professor of medicine at Tufts School of Medicine, and Elysium Health Scientific Advisory Board member. "This study provides novel evidence that targeting pathways of aging with natural compounds could help reduce liver inflammation in patients with this condition–an exciting proposition that calls for further research."
Basis is a combination of Elysium Health's proprietary nicotinamide riboside (NR-E) and pterostilbene (PT), which is designed to increase NAD+ levels and activate sirtuins. As an essential coenzyme involved in hundreds of metabolic processes, NAD+ has a critical role in the conversion of NAD+ to NADH for mitochondrial metabolism and the resulting synthesis of ATP–how cells create energy. The activation of sirtuins, which are NAD-dependent, also regulates important physiological processes like lipid metabolism. In an earlier clinical trial, Basis was shown to increase and sustain NAD+ levels on average by 40% from baseline.
"While NAFLD is not classified as a disease, it can lead to more severe liver conditions, such as NASH and cirrhosis," said Leonard Guarente, Ph.D., senior author on the study, Elysium Health chief scientist, and director of the Glenn Center for Biology of Aging Research at MIT. "It is also a sign of metabolic syndrome, which may lead to diabetes. Our exploratory trial of NRPT (Basis) in NAFLD individuals showed that liver inflammation, quantified by three relevant measures, was reduced in the group given the recommended dose of Basis over six months. These results indicate that Basis may be an efficacious supplement in people with NAFLD. Future trials are warranted to confirm these findings and test whether NRPT can slow progression of NAFLD to more severe liver conditions."
The randomized, double-blind, placebo-controlled trial involved 111 healthy adults with NAFLD aged 18 to 70 in three treatment arms - placebo, recommended dose of Basis (NRPT 1X), and double-dose of Basis (NRPT 2X), comparing the effects of the two doses of Basis to the matching placebo over the course of a 26-week treatment period. The study can be found on www.clinicaltrials.gov under the identifier NCT03513523.
About Elysium Health™
Elysium Health's™ mission is to solve the biggest challenges in health with science, to help people lead healthier lives. Working directly with the world's leading scientists and clinicians, Elysium Health™ is committed to translating critical advancements in aging research into health solutions people can access today. Learn more at elysiumhealth.com.
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SOURCE Elysium Health