Elysium Health™ Announces Initiation of Phase II Clinical Trial at Mayo Clinic to Evaluate BASIS™ for Prevention of Acute Kidney Injury After Cardiac Surgery
NEW YORK, Dec. 15, 2020 /PRNewswire/ -- Elysium Health, Inc.,TM a life sciences company developing clinically validated health products based on aging research, today announced the initiation of a Phase II clinical trial at Mayo Clinic to evaluate the efficacy of BASISTM for the prevention of acute kidney injury (AKI) in patients that have undergone a cardiac surgery. The company previously announced the acceptance of an Investigational New Drug (IND) application by the Food and Drug Administration (FDA) to evaluate the efficacy of Basis for the prevention of AKI. This marked the first IND approval for Elysium Health and its cellular health supplement Basis, a rare accomplishment for a dietary supplement. The Phase II, randomized, double-blinded, placebo-controlled clinical trial will be conducted at Mayo Clinic and is led by principal investigator Eduardo Chini, M.D., Ph.D., whose research specializations include aging, kidney disease, nicotinamide adenine dinucleotide (NAD+) metabolism and functions, and sirtuin 1 (SIRT1) function and regulation. The study will evaluate the efficacy of Basis for kidney protection against AKI in patients treated by complex aortic aneurysm repair and aortic arch reconstruction.
In 2018, a successful Phase I dose-escalating study to evaluate the safety of Basis in patients with AKI was conducted at Massachusetts General Hospital. In another earlier published clinical trial, Basis was shown to increase NAD+ levels safely and sustainably by an average of 40% from baseline in healthy adults. Often referred to as the "guardians of the cell," sirtuins are NAD-dependent enzymes that play a diverse role in cellular energy metabolism and maintaining undamaged DNA. In preclinical studies, animals that were deficient in SIRT1 have been shown to be more susceptible to developing AKI.
"While upwards of 30% of surgical cardiac patients are estimated to experience an incidence of AKI, it is a complication that generally affects 3% of all hospitalized patients," said Elysium Health chief scientist and director of the Glenn Center for Biology of Aging Research at MIT Leonard Guarente, Ph.D. "Preclinically, it's been demonstrated that the sirtuin SIRT1 is highly protective against kidney damage due to oxidative injury, and raising the activity of this sirtuin with NAD+ precursors is thus protective and restorative of kidney function. Dr. Chini's research focus on aging and kidney disease, among other areas, with a special interest in NAD+ metabolism and its functions, make him well-suited to lead this trial. We are looking forward to continuing to work with him and his team at Mayo Clinic."
AKI is a frequent complication in patients who undergo open surgical or endovascular repair and is associated with significant morbidity and mortality. According to the CDC's 2014 report – Trends in Hospitalizations for Acute Kidney Injury – the total number of hospitalizations with acute kidney injury increased from 953,926 in 2000 to 1,823,054 in 2006 and 3,959,560 in 2014 and this trend of increasing cases is expected to continue. Clinicians increasingly recognize acute kidney injury as an in-hospital complication of sepsis, heart conditions, and surgery. It is associated with higher likelihood of long-term care, increased incidence of chronic kidney disease, increased hospital mortality, and higher health care costs. A number of U.S. studies have indicated an increasing incidence of dialysis-treated acute kidney injury since the late 1990s. AKI has also been a noted complication for hospitalized patients with severe COVID-19 infections throughout the pandemic.
"Directed by Elysium Health's mission, our work focuses on identifying unmet needs and developing products to support lifelong health with the goal of preventing age-related preconditions and conditions," said Elysium Health CEO Eric Marcotulli. "It's incredibly rare for a supplement to receive IND approval and proceed to a Phase II clinical trial, especially at an institution as renowned and respected as Mayo Clinic. We are excited to work with Dr. Chini and his team and for the potential to establish a clinically proven method for the prevention of a condition that has life-changing implications and no available treatments."
Two hundred thirty-eight adults, ages 18 and older, undergoing complex aortic aneurysm repair or aortic arch reconstruction will be enrolled in the double-blind, placebo-controlled, randomized trial. The study will compare the effects of Basis, with administration for two weeks before surgery and six weeks after surgery, to a matching placebo. The primary study completion date is October 2023, and more information can be found on clinicaltrials.gov under the identifier NCT04342975.
Mayo Clinic and Dr. Chini have a financial interest in Elysium Health through its licensing arm, Mayo Clinic Ventures. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research.
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 scientific research into health solutions people can access today. Learn more at elysiumhealth.com.
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SOURCE Elysium Health