Multiple ingredients from prebiotic fibers to bacteria are claimed to trigger the production of appetite-regulating hormones such as GLP-1. But they don’t have the same effects as drugs that linger in the body for days, says Evolv cofounder Becca McCarthy.
San Francisco-based Evolv, she says, is targeting the sweet spot between these two options with Evolv GLP-1, a “biomimetic” dietary supplement made from baker’s yeast that has been engineered to produce a peptide that engages GLP-1 and GIP receptors and has a half-life of 1-2 days.
Rather than triggering GLP-1 and GIP production in the body, the supplement mimics these hormones but is not broken down so quickly by the enzyme DPP-4, which starts breaking down naturally-produced GLP-1 within minutes.
According to McCarthy: “What we’ve created is a GLP-1 and GIP receptor agonist oral supplement that is as effective as your endogenous native GLP-1 and GIP processes in the body, but extended and prolonged throughout a period of about 24 hours, or slightly longer, compared to 5-7 days for injectable drugs.”
Human clinical study underway
While blockbuster drugs such as Ozempic and Mounjaro are disrupting the weight loss market, many people cannot access, afford or tolerate them, said cofounder Dr. Cory Henderson, who founded Evolv with Dr. Kwang-Chul Kwon and McCarthy.
“I studied every GLP-1 receptor activating molecule that was out there. I spent months doing computational modeling [to design peptides with amino acid structures that would engage with the receptors] within a narrow category as I couldn’t choose a molecule that had previously been tested in a clinical context [because it could not then be legally marketed as a dietary supplement].
“Then I did a bunch of in vitro receptor activation assays to demonstrate that the molecule I designed interacted with the GLP-1 and GIP receptors, which is actually not something you can really measure in the body, where you have to look at things like impact on weight or glycemic control.”
Animal studies then followed, “which were really all about safety and toxicity to demonstrate that even at extremely high levels, it wouldn’t be dangerous,” he added.
“We’re now mid-way through a 90-day human clinical study with 120 participants looking at weight loss, appetite suppression, and HbA1C.”
Sweet spot between existing supplements and Ozempic et al
According to McCarthy: “We are a dietary supplement, so can’t make drug comparative claims, but if you think about the spectrum of products that exist in this category, at one end of the spectrum, you have drugs, and on the other you have supplements that like berberine or green tea extract. We sit somewhere in the middle of that spectrum and sit in a category called biomimetics.”
Henderson added: “The typical supplements get your own GLP-1 to be expressed, but it’s broken down very quickly in the body. We needed to design a new molecule that could both get across the intestinal epithelium and would also be resistant to those peptidases [the DPP-4 enzyme] we talked about.
“With the drugs, they are making these modifications like fatty acid lipidation that keeps them in your body for days at a time. We wanted something in the middle that was able to appropriately activate those receptors, but then also be able to clear effectively from your body.”
Platform can extend beyond GLP-1
Rather than extracting the peptide from the engineered yeast at great cost, Evolv is selling the dried shelf-stable yeast itself as the supplement. Once it hits the digestive tract, the peptide is then released and starts engaging with GLP-1 and GIP receptors, he said.
“The great thing about our platform is that it can be applied to any broad range of biologics that you might want to deliver orally. We don’t have to worry about refrigeration, and we don’t have to do purification [to extract the peptide], which can be very expensive. Also, nutritionally, yeast is a good supplement in and of itself.”
According to McCarthy, Evolv has submitted a new dietary ingredient notification (NDIN) to the FDA (which is not yet publicly available as there is a time lag on the website).
‘The response has been absolutely amazing’
The Evolv GLP-1 supplement has just been launched direct-to-consumer, said McCarthy. “The response has been absolutely amazing. We’re really excited about the early traction. The vast majority of our early adopter customers are also becoming brand evangelists and ambassadors for us.”
Beyond the initial direct-to-consumer launch, she added, “We have designs for other channels, strategic partnerships, and brand partnerships that will start to roll out over the next 12 months.
“Right now, we’re really focused on the supplement. We see the most demand for that. There’s a big gap in the GLP-1 space between a once-daily supplement of something like Berberine and an injection of diabetes medication. So that’s the gap we’re solving for most immediately. But the sky’s the limit, and we’re open to a lot of different formats and innovations.”
Evolv, which has raised a pre-seed round of $5.8 million, has been able to “tap into existing supply chain infrastructure for yeast manufacturing in the US” to manufacture the product, so does not need to raise money to fund capex, she added.
Further reading:
Where Siddhi Capital is placing its bets: ‘GLP-1 is our AI. It’s a huge opportunity’
‘Pharma is eating Big Food’s lunch…’ Lembas fights back with GLP-1 boosting peptide
ProFuse Technology expands focus from cultivated meat to drug discovery amid GLP-1 drug boom
GLP-1 drugs are rewriting America’s food preferences, says IFF: ‘GLP-1s alter taste perception’
