Encouraging news from Elysium Health illustrates that the Longevity supplements market is building clinical and commercial traction.
Longevity.Technology: The Longevity supplements market is heating up, and the release of trial data from New York-headquartered Elysium Health demonstrates that momentum of the Longevity supplements market is set for growth.
Due to the ongoing coronavirus pandemic, Elysium’s NAD+ baseline study is ongoing, but the company recently shared the results of two studies for Basis with Longevity.Technology.
The first, an acute kidney injury (AKI) Phase I dose-escalating safety study conducted at Massachusetts General Hospital, enabled the company to receive acceptance of its first Investigational New Drug (IND) application from the FDA late last year. A rare achievement for a dietary supplement, the IND approval allows for a Phase II AKI clinical trial to evaluate the efficacy of Basis for kidney protection against AKI in surgical cardiac patients, which is scheduled to begin later this year.
The second published study – a 90-day toxicity study – demonstrates the superior safety of Elysium’s proprietary nicotinamide riboside (NR-E) compared to other NAD+ precursor consumer products.
The studies mark the third and fourth publications for Elysium, following the publication of the company’s first clinical trial in 2017, which demonstrated that Basis safely and sustainably increases NAD+ levels by an average of 40%, and the publication of a pilot study evaluating the efficacy of the company’s experimental therapeutic EH301 for amyotrophic lateral sclerosis (ALS).
The news of the two studies is encouraging and comes on the back of the launch of Elysium’s long-term brain health product ‘Matter’, which was developed in partnership with the University of Oxford.
“… IND approval 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.”
Commenting on the AKI Phase I trial, Leonard Guarente, Ph.D., Elysium chief scientist and director of the Glenn Center for Biology of Aging Research at MIT said: “Our Phase I trial was a collaboration that was made possible by Elysium’s open-access research model, and it combined research that has come out of numerous labs with ongoing work related to AKI and chronic kidney disease at Massachusetts General Hospital.
The IND approval 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.”
Nicotinamide riboside is a precursor to NAD+ and classifies as GRAS (generally recognized as safe) for use in foods. While it may be true that the NAD+ synthesis enzyme, NAMPT, declines with aging, it is only one contributing factor to the age-related reduction in NAD+.
New market-entrant Nuchido, whose CEO we interviewed last week, claims that its NAD+ supplement can increase NAD+ levels by a factor of four, but we understand that they have not yet demonstrated such an increase in a placebo-controlled clinical trial and it is perhaps unnecessary according to Guarente.
Guarente added: “In 2016, Elysium Health demonstrated in a 120-person, eight-week, placebo-controlled, double-blinded, randomized trial that the recommended dose of Basis safely and sustainably increases NAD+ levels by an average of 40%. NAD+ only declines by less than twofold with aging, so any increase beyond twofold may be unimportant.
Unlike other NAD+ boosting products, Basis contains not only an NAD+ precursor, nicotinamide riboside, but also pterostilbene, which activates the critical sirtuin, SIRT1, selectively and allows synergy with NAD+ boosters. “Data with an N=1 presented in a recent poster from Nuchido can not be taken as a reliable indication of the effects of an intervention on raising NAD+ levels.”
‘Basis’ is available from Elysium with prepaid subscription plans starting at $40 per month; single bottles are also offered for purchase.