Elysium Health™ Announces FDA Acceptance of Investigational New Drug Application to Evaluate BASIS™ for Prevention of Acute Kidney Injury in Surgical Cardiac Patients
NEW YORK, Sept. 19, 2019 /PRNewswire/ -- Elysium Health, Inc.,™ a life sciences company developing clinically validated health products based on aging research, today 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 acute kidney injury (AKI) in surgical cardiac patients. 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. The approved IND enables the initiation of a Phase II, randomized, double-blinded, placebo-controlled clinical trial to evaluate the efficacy of Basis for kidney protection against AKI in patients treated by complex aortic aneurysm repair and aortic arch reconstruction, which is scheduled to begin later this year.
The IND marks the first acceptance for the company and its cellular health supplement Basis, which is designed to reverse the age-related decline of the critical coenzyme NAD+ and activate sirtuins. In an earlier published clinical trial, Basis was shown to increase NAD+ levels on average by 40% from baseline in healthy adults. Often referred to as "longevity genes," sirtuins are NAD-dependent, anti-aging enzymes that play a diverse role in cellular energy metabolism and gene regulation. 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, Dr. Leonard Guarente. "Preclinically, it's been demonstrated that the regulation of NAD+ biosynthesis plays a pivotal role in renal recovery from injury. The sirtuin, SIRT1, is highly protective against kidney damage due to oxidative injury, and raising the activity of this sirtuin with NAD+ precursors is also protective and restorative of kidney function. Our Phase I trial was a collaboration that was made possible by Elysium Health's open-access research model, and it combined work that has come out of numerous labs with ongoing work related to AKI and chronic kidney disease at Massachusetts General Hospital. This IND is an exciting advancement for Elysium Health but also more broadly for the field of aging research, as it allows for the further exploration of a potential treatment that targets a fundamental process of aging."
AKI is a frequent complication in cardiac 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. 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.
"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 conditions," said Elysium Health CEO Eric Marcotulli. "While it's incredibly rare for a supplement to receive IND approval, we are most excited about the further study that this acceptance enables and the potential to establish a clinically proven method for the prevention of a condition that has life-changing implications and no available treatments."
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