Acute kidney injury is a common complication in patients who undergo open-heart surgery or cardiovascular repair linked to reduced health- and life-span. These patients also have an increased likelihood of long-term care, chronic kidney disease, and hospital mortality as well as higher health care costs. Also, acute kidney injury has been a noted complication for hospitalized patients with severe COVID-19 infections throughout the pandemic. So, there is a medical gap in the prevention of acute kidney injury caused by cardiovascular-related surgeries and other conditions like COVID-19.

Elysium Health, Inc. announced the initiation of a Phase II clinical trial (NCT04342975) for the prevention of acute kidney injury in patients that have undergone cardiac surgery. The study will compare the effects of their antioxidant and nicotinamide adenine dinucleotide (NAD+) supplement called BASISTM, with the administration for two weeks before surgery and six weeks after surgery, to a matching placebo. The primary study will take place at the Mayo Clinic and will enroll 138 adults, ages 18 and older, undergoing complex aortic aneurysm repair or aortic arch reconstruction. The Phase II trial has a target completion date of October 2023.

Elysium Health’s BASIS consists of the NAD+ precursor nicotinamide riboside (250 mg) and the antioxidant pterostilbene (50 mg). Nicotinamide riboside has been shown to increase levels of the vital molecule NAD+, which is critical to innumerable functions in cells and whose levels decline during aging. This NAD+ precursor has recently been in the news as the subject of a patent dispute. Pterostilbene is found in certain berries, particularly blueberries, that have demonstrated benefit to cholesterol, blood pressure, and oxidative stress in animals. It is chemically similar to the antioxidant resveratrol, which is also an activator of the anti-aging enzyme sirtuin 1 (SIRT1).

The Phase II clinical trial will be led by Eduardo Chini, M.D., Ph.D., a research specialist in aging, kidney disease, NAD+ metabolism and functions, and the function and regulation of SIRT1. This enzyme plays an essential role in keeping cells youthful and healthy and can only function in the presence of NAD+. SIRT1 is important for kidney health, as shown by studies where animals lacking this enzyme were more susceptible to developing acute kidney injury.

“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,” said Elysium Health chief scientist and director of the Glenn Center for Biology of Aging Research at MIT Leonard Guarente, Ph.D., in a press release. “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.”

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 BASISTM for the prevention of acute kidney injury. “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,” said Elysium Health CEO Eric Marcotulli in a press release. “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.”   

In 2018, a successful Phase I dose-escalating study to evaluate the safety of BASISTM in patients with acute kidney injury was conducted at Massachusetts General Hospital. In another earlier published clinical trial, BASISTM was shown to increase NAD+ levels safely and sustainably by an average of 40% from baseline in healthy adults. “While upwards of 30% of surgical cardiac patients are estimated to experience an incidence of acute kidney disease, it is a complication that generally affects 3% of all hospitalized patients,” said Dr. Guarente in a press release.

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.