Life sciences company Elysium Health Inc revealed on Thursday that its New Drug (IND) application has been accepted by the US Food and Drug Administration (FDA) to evaluate the efficacy of BASIS for the prevention of acute kidney injury (AKI) in surgical cardiac patients.

AKI is a frequent complication in cardiac patients who undergo open surgical or endovascular repair and is associated with significant morbidity and mortality

The IND is based on the company's successful Phase I dose-escalating study to evaluate the safety of Basis in patients with AKI at Massachusetts General Hospital. The IND marks the first acceptance of its cellular health supplement Basis, which is designed to reverse the age-related decline of the critical coenzyme NAD+ and activate sirtuins.

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 the company's earlier published clinical trial, Basis was shown to increase NAD+ levels on average by 40% from baseline in healthy adults. In preclinical studies, animals deficient in SIRT1 have shown to be more susceptible to developing AKI.

Later this year, the company will launch 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.