Amplifye, a UC Davis spinout led by former Amyris CEO John Melo, has launched its first product: a proprietary enzyme (P24) claimed to optimize protein digestion, unlocking a range of health benefits from improved blood glucose control to better sleep.
Formerly known as Digestiva, Amplifye leverages computational protein design methods to discover novel enzymes, focusing on a family of proteases (enzymes that break down proteins) called S53.
Founded in 2019 by Dr. Wilson Mak, Dr. Justin Siegel, Dr. Glenn Nedwin, and Dr. Bruce German, the company is on a mission to improve protein digestibility such that “more amino acids and small peptides are absorbable, delivering better nutrition.”
By commencing protein digestion early in the stomach (the enzyme is activated by stomach acid), P24 can also reduce digestive stress, claims the startup, which raised an $18.4 million Series A round last summer led by sugar cane processor Magdalena.
‘Bioactivity that wasn’t there before’
“Some of us are great digesters, others are not,” CEO John Melo tells AgFunderNews. “There isn’t an easy proxy [for how efficient we are at digesting protein]. But you can measure blood glucose levels after a meal, amino acid uptake in the blood, and then longer term you can monitor things like muscle mass over time.”
Melo, who joined Amplifye in 2023, explains: “What we’re trying to do is speed up the digestion process so that you get to a unique profile, both in peptides and amino acids. After we impact a protein with our enzyme, we see, on average, about a 30% increase in smaller peptides. We also see a unique signature of amino acids, with typically the essential amino acids increasing in concentration.”
He adds: “We’re cutting peptides very precisely, and that’s giving us a unique signature in amino acids and providing bioactivity that in some cases was not there before.
“Our fundamental message is to unlock the optimal nutritional benefit in every gram of protein you consume.”
Testing and validation
Amplifye is planning a human clinical study to validate its claims, and has a patent addressing the ability of P24 to help manage blood glucose, and/or lower the glycemic index of foodstuffs.
It has also done extensive work with the INFOGEST 2.0 model gut system (an in vitro digestion model used to simulate how food is digested in the human gastrointestinal tract), says Melo.
“We take a protein, we hydrolyze it using our enzyme and look at what we have done to the peptides, where have we cut them, and what’s happening with bioavailability. We’ve done that thousands of times with different proteins.”
A study using the INFOGEST 2.0 system published in the journal Frontiers in Nutrition early last year showed that P24 substantially improved the digestibility of animal and plant proteins including soy, pea, chickpea, rice, casein, and whey, elevating protein digestibility by 115% during the gastric phase and by 15% in the intestinal phase, based on the degree of hydrolysis.
The benefits of P24 (tagline: “The enzyme that can double protein absorption”) were particularly notable with plant proteins, which generally have lower protein digestibility (PDCAAS and DIAAS) scores than animal proteins, according to the study.
Amplifye also conducted an at-home consumer study earlier this year in which volunteers were asked to take P24 with their largest meal of the day over an extended period and provide feedback on everything from digestive comfort to mental clarity and sleep, areas that Amplifye believes could all be impacted by improved protein digestion.
“We were trying to connect the predictions we were making to the cut of the protein, or the amino acid and peptide profile to what people might expect to feel,” says Melo. “We had quite a bit of positive feedback and in light of that and all the data we have comparing this enzyme to other proteases in the market, we felt confident about bringing it to market. We believe it is the best performing acid activated protease on the market today.”
Blood glucose control
According to Melo: “You see steady blood glucose level with our enzyme so you don’t have spikes after a meal, which we think has a lot to do with changing the rate of digestion. You also change how you are absorbing amino acids, and [unlocking] peptides [which] may have an impact on receptors that affect blood glucose control.”
He adds: “Indirectly, I think we’re affecting insulin production because our enzyme is cutting peptides, some of which have bioactivity that connects to GLP-1 [a gut hormone which boosts insulin release when blood glucose levels are elevated].”
Regulatory and go-to-market
P24 is self-affirmed GRAS (Generally Recognized as Safe) and now available in supplement form direct to consumer, says Melo, who is also targeting undisclosed industrial applications in which the enzyme would serve as a processing aid.
Another key area of focus is the animal feed market, with a recent study suggesting P24 can reduce mortality rates in shrimp fed brewers’ spent yeast as a protein source by “unlocking certain peptides” that reduce inflammation.
P24 is produced via precision fermentation, says Melo. “We are now operating at scale. Our last runs were [in] 40,000-liter [bioreactors] and we’ll be in 100,000-liter tanks by the end of the year. We’re currently using a couple of contract manufacturing sites in India for our production but we also have a commitment from Magdalena [a sugar cane processor and key investor in Amplifye] to invest in a large-scale facility.
“We’re probably 24 months away from having a dedicated facility. Until then, we’ll use CMOs to ramp up our volume.”
Amplifye has filed four provisional patents in recent weeks with eight more in the pipeline, says Melo. “We’re pretty well protected around not just P24, but the platform technology to develop multiple enzymes.”
For industrial applications in which the protease could be used to turn a lower value protein into a higher value product, P24 can deliver significantly better bioavailability at significantly lower cost, “because we don’t need to use as much to be effective,” he claims.
“When you think about an enzyme, you’re looking for the unique site [on a peptide] that it’s cutting and then the load… how much enzyme do you need to effectively process a protein? With P24, these two things really come together.”
