• by Les Luchter , Staff Writer, December 5, 2024

Amino acids have long been labeled as the building blocks of life. For one company, they may be building a health empire.

Through AI, Amilyfe Bioscience has mapped over 1 quintillion combinations of amino acids and has so far identified over 50 formulations targeting health conditions in 25 categories.

If “you could take elemental amino acids in precise combinations as opposed to the way that we get them through foodstuffs, kind of co-mingled and haphazard, they act as what are called cell signalers,” Amilyfe Chairman/Chief Executive Officer Stephen Gatto tells Pharma & Health Insider. As a result, “you could correct imbalances.”

Amilyfe’s first products are Enterade, developed to treat side effects of cancer patients undergoing chemotherapy and radiotherapy, and Enterade IBS-D, treating diarrhea-predominant irritable bowel syndrome.

Since launching over the past couple of years, they’ve been sold largely to medical facilities, but also direct to consumers via Enterade.com and Amazon. Gatto also reports “large interest from retail.”

The products are available in both ready-to-drink form and in stick packs, for mixing into water.

Enterade has already been used in around a thousand cancer clinics and has served some 60,000 patients in the U.S. alone, Gatto says.

No prescription is needed, since they’re classified as medical food, a step up from supplements. Unlike supplements, Gatto explains, medical foods “are clinically tested and proven under very rigorous conditions.”

Around February or March, Amilyfe plans to launch its third product: to address the diarrhea and constipation symptoms of people taking GLP-1 drugs for obesity and/or diabetes.

With the increased popularity of these drugs, these side effects are “a massive issue,” notes Gatto. In a study of over 1,000 patients “55% had diarrhea, and that that was something that significantly affected their lives.” Meanwhile over half of health-care providers said that for their patients on GLP-1 drugs, “constipation was the number one issue.”

“Now this is huge,” especially “because 60%-65% of the population of patients are women, and they become very vocal on social media.”

Another upcoming product is a sports drink, called Xceed and awaiting commercialization.

Through some half dozen clinical trials for Enterade, as well as work with NASA, “we also learned that amino acids in the correct and precise combination, could dramatically improve hydration status,” Gatto continues. 

“Amino acids are eight times more efficient at bringing electrolytes and water into the body than water alone,” he reports. “And they are four times more efficient than any glucose-based beverage. That means faster, longer-lasting hydration without the sugar.”

That brings Amilyfe into potential competition with PepsiCo’s Gatorade, Coca-Cola’s Powerade, Uniliver’s Liquid I.V., and even Abbott’s Pedialyte.

To market XCeed, Amilyfe, per its website, is looking to connect with distributors or others “involved in the beverage industry.”

That jives with a business strategy in which Amilyfe has been partnering up with various players to bring its numerous formulations forward.

One of its health categories is respiratory, and Gatto points out how AmiLyfe’s partnership with Reckitt might work with that company’s Mucinex cold and flu brand: “We could take this and create brand extensions.”

“We can take these formulas and put them in anybody’s product and make those products better, faster, longer-lasting,” he declares.

Other current partnerships are with Nuvara therapeutics, Vyve skincare, and Cindy Crawford’s Meaningful Beauty.

The latter has added an Amilyfe product to its Age Recovery Night Cream, which Crawford explains in a video has been “reformulated with Aamplfy, an amazing blend of amino acids that boost skin resilience.” 

In the future, Gatto says, licensing will become ‘a very, very big part of our business.”

“The brand side is going to be hyper-focused on areas where we can be disruptive, where we have a vastly differentiated platform that we can offer patients, where we can make them feel better,” he explains.

Amilyfe has directed most of its marketing so far at healthcare providers through such areas as symposiums and other industry gatherings.

Consumer marketing has focused on cancer patients and their caregivers, but “we are right now looking to expand and grow exponentially – to expand our social media presence, our direct marketing and really focus on the needs states and patients.” Also in the plans: a “substantial increase” in paid advertising next year.

Here’s Shannon Miller, medal-winning Olympic gymnast and cancer survivor, in an early Enterade influencer video.