Bactolife, a Danish startup on a mission to unlock a novel category of gut health ingredients with binding proteins, is aiming to launch its first products in the US market next year.
Probiotics (live microorganisms that confer health benefits) add to the mix of beneficial bacteria in the gut, while prebiotics provide food for these “good” bacteria. Antibiotics, meanwhile, are blunter instruments that kill harmful and good bacteria alike and can significantly disrupt the microbiome.
Binding proteins, in contrast, are precision tools that neutralize unhealthy microbes without disrupting the microbiome by selectively locking on to metabolites produced by the unhealthy microbes and preventing them from getting through the gut barrier.
Once they bind to their targets, the unhealthy metabolites in question move through the GI tract and are flushed out, without causing damage, says Bactolife, which was inspired by igG fragments found in immunoglobulins in the milk of camelids (camels, llamas, and alpacas) that are known to confer immune health benefits.
Rather than extracting the proteins from camel milk (not super-practical), Bactolife engineers microbes to express them at scale via precision fermentation.
‘A clear mode of action’
Immunoglobulins from camelids have a simple structure and a binding domain comprising a single polypeptide chain, serving as small stable proteins with a targeted binding activity, explains Liz Spence, who has just been hired to spearhead Bactolife’s operations in the US.
“What was most exciting to me [about Bactolife] was its highly differentiated technology with a very clear mode of action. We’re talking about a proactive gut health solution that has broad applicability to a range of consumers. The company [which has raised $50 million to date] is also backed by very strong investors including Novo Holdings, ATHOS, and the Gates Foundation.
“We anticipate having self-GRAS status for our first two binding proteins in the middle of next year, and we have our first partnership agreements in place for next year’s launch.
“And then over the course of the next three to five years, we’ll be launching a whole portfolio of binding proteins that have applicability across the most common gut health concerns. We are also preparing submissions in Asian countries and as a novel food in Europe.”
Leaky gut
Spence, a food and ag industry veteran who has worked in senior roles at Cargill, Verily, and Mineral.ai, acknowledges that binding proteins are a new concept to consumers, many of whom are still trying to get their heads around pre-, pro-, and postbiotics.
However, many consumers are aware that harmful bacteria can cause digestive issues such as gut disruption caused by unhealthy microbes, that a “leaky gut” is harmful, and that there is a connection between the gut microbiome and overall health, she says.
And this presents an opportunity for Bactolife to speak to specific buckets of consumers, from travelers to people experiencing periods of heightened stress, to the elderly, for whom changes in immune function and other factors associated with aging can create challenges in maintaining optimal gut health.
“One of our first binding proteins that will be going to market has the potential to help individuals with compromised gut health, such as people recently on antibiotics, and the elderly at nursing homes or hospitals. These groups are especially susceptible to gut issues – from mild to severe,” says Spence.
“Other things we’re looking at are metabolites associated with common types of E. coli.”
The go-to-market strategy
Unlike probiotics (which as live microbes do not work in many food applications), binding proteins (which are heat and pH stable) can be used in a wide range of food and supplement applications and are highly effective in very small doses [100-200 milligrams], says Spence.
“Unlike some animal-derived IgG solutions on the market, they work effectively at low daily intake and are easy to formulate with. They are also vegan-friendly, allergen-free, and lactose-free.”
She added: “We see the path to market through partnering with supplement brands, particularly with healthcare practitioner brands, and then down the road we hope to partner with medical nutrition and functional food and beverage companies as well. Our aspiration is to be cost competitive to not just purified bovine colostrum [which is rich in immunoglobulin G or ‘IgG’] but other gut health ingredients out there on the market.”
Bactolife is currently talking to a range of potential partners, with some expressing interest in creating formulations that combine Bactolife binding proteins with other gut health ingredients such as pre- and probiotics.
She added: “We see this as a unique additive to the current suite of gut health solutions. I think consumers more and more are understanding that ‘biotics are important for feeding and seeding beneficial bacteria, but everyone, over the course of their life goes through a time of unbalance or struggle with their gut. And during those times, there aren’t a lot of other tools to help remove what does not belong.
“Binding proteins are a way to proactively rebalance the gut. So if you know you’re going on a trip, or there’s an upcoming time of potential gut stress, take this product before, during, and after to maintain that balance or play it safe and include it in your daily supplement regimen.”
Claims could include things like, “supports a healthy gut barrier” or “maintains microbiota diversity,” says Spence, who says Bactolife has robust in-vitro data from gut simulators and in-vivo (animal) data to back up such claims. It is also investing in human intervention studies addressing tolerance and consumer experience studies as well as efficacy.
Consumers and the gut microbiome
While consumer and industry education will be required to support market entry for binding proteins, says Spence, “I think the awareness and the interest of consumers in the power of their microbiome has increased exponentially since my time at Epicor [Cargill’s postbiotic product, which Spence worked on until 2022].
“The fact that prebiotics are now in the mass market in soda [through brands such as Poppi and Olipop] is a huge indicator.”
Further reading:
BiomEdit raises $18.4m Series B to expand designer probiotics platform