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Elysium Health™ Announces Phase II Trial for Preventing Acute Kidney Injury Following Heart Surgery with NAD+ Plus Antioxidant Supplement

The clinical study will evaluate the effectiveness of nicotinamide riboside and pterostilbene treatment to protect the kidneys of heart surgery patients.

By Noemi Canditi

A complication that frequently occurs in patients who undergo open cardiovascular repair or open-heart surgery is acute kidney injury, and evidence suggests that this condition is associated with diminished health- and lifespan. Unfortunately, the chances of hospital mortality, accruing health care costs, receiving long-term care, and developing chronic kidney disease are all increased in people diagnosed with acute kidney injury. In addition, hospitalized COVID-19 patients with extreme infections were found to exhibit acute kidney injury throughout the pandemic. Moreover, there is a knowledge gap in preventative medical therapeutics for acute kidney injury in COVID-19 patients and patients that underwent cardiovascular-related surgeries.

Elysium Health, Inc. notified the start of a Phase II clinical trial (NCT04342975) attempting to utilize preventative therapeutics to combat acute kidney injury in patients undergoing cardiovascular-related surgeries. In this trial, investigators will differentiate the effects between their antioxidant and nicotine adenine dinucleotide (NAD+) supplement called BASISTM and a matching placebo. Investigators will administer the supplement or placebo to patients two weeks prior to surgery and six weeks post-operation. The Mayo Clinic will facilitate the primary study, comprised of 138 adults aged 18 and older who will undergo intricate aortic aneurysm repair or aortic arch reconstruction. The Phase II trial aims to complete experimentation by October 2023.

The NAD+ precursor nicotinamide riboside (250 mg) and the antioxidant pterostilbene (50mg) make up Elysium Health’s supplement BASIS. Evidence indicates that nicotinamide riboside elevates levels of the energy-producing compound NAD+, which facilitates a myriad of cellular functions and is known to decrease in concentration as humans age. Recently, news revealed that the main topic in a patent dispute is nicotinamide riboside. Some berries, especially blueberries, are known to contain pterostilbene and have been shown to improve cholesterol, blood pressure, and mitigate oxidative stress in animals. The chemical makeup of pterostilbene is close to that of the antioxidant resveratrol, which activates sirtuin 1 (SIRT1), an enzyme with anti-aging effects.

Eduardo Chini, M.D., Ph.D. will lead the Phase II clinical trial. Dr. Chini specializes in research about kidney disease, aging, NAD+ metabolism, and the regulation and function of SIRT1. For SIRT1 to function properly and promote cellular health, cells must contain sufficient amounts of NAD+. Optimal SIRT1 function is essential for kidney health, as exhibited by previous animal studies where animals with insufficient amounts of SIRT1 were more likely to develop 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.”

It was previously reported that the Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application from Elysium Health, Inc. to assess whether BASISTM is effective in preventing 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.”

At Massachusetts General Hospital in 2018, a conducted Phase 1 dose-escalating trial that investigated the safety of BASISTM in patients exhibiting acute kidney injury was successful. In a different previous clinical trial, investigators successfully showed that healthy adults who were safely treated with BASISTm displayed elevated NAD+ concentrations that were on average 40% greater than what was seen at baseline. “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.

 Through its licensing arm, Mayo Clinic Ventures, Mayo Clinic and Dr. Chini possess a financial stake in Elysium Health. All revenue received by the Mayo Clinic will be utilized to aid its nonprofit mission in education, patient care, and research.

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