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Investigational new drug application accepted for treatment to prevent AKI after cardiac surgery
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The FDA has accepted an investigational new drug application to evaluate the efficacy of Elysium Health’s cellular health supplement in preventing acute kidney injury in patients who undergo cardiac surgery.
According to a press release, the supplement — entitled Basis — is meant to reverse the decline of the coenzyme NAD+, which occurs due to aging, and to activate anti-aging enzymes known as sirtuins.
“While upward 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,” Leonard Guarente, PhD, chief scientist at Elysium Health and director of the Glenn Center for Biology of Aging Research at MIT, said in the release. “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.”
The FDA action follows successful phase 1 study results that evaluated the safety of Basis in patients with AKI at Massachusetts General Hospital. Phase 2 — a randomized, double-blinded, placebo-controlled clinical trial designed to determine if Basis provides kidney protection in patients treated with complex aortic aneurysm repair or aortic arch reconstruction — will begin later in 2019.
“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,” Eric Marcotulli, CEO of Elysium Health, said. “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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