Binding proteins are fragments of immunoglobulins which can be found naturally in camel’s milk. Produced via precision fermentation, they bind to and neutralize harmful metabolites, enhancing gut resilience.
After successfully closing its Series B funding round, Bactolife is preparing to launch its binding protein products under the brand Helm, first in the U.S, followed by Europe and Asia.
The company expects the launch to change industry perspectives on gut health and spark the creation of new gut health solutions such as dietary supplements, functional foods and beverages, and animal feed.
“Binding Proteins have the potential to fundamentally shift how we think about gut health, moving the focus from treatment to proactive health management,” Sebastian Søderberg, CEO of Bactolife, told NutraIngredients.
“Within five years, we expect to have launched additional binding proteins relevant to a broader range of everyday gut challenges and established a presence in the US, EU and Asia. We also aim to make our products available in the low- and middle-income countries, where improving gut health has the potential to radically transform—and in some cases save—lives by helping people stay healthy.”
How do binding proteins differ from other gut health solutions?
Binding proteins were first discovered in the 1990s by scientists researching the natural immune properties of camelid immunoglobulins (found in animals like camels, llamas and alpacas). They discovered that specific fragments could bind to harmful toxins and pathogens without disrupting beneficial bacteria in the gut microbiome.
This novel ingredient therefore differs from other gut health solutions on the market, according to Bactolife CSO and co-founder Sandra Wingaard Thrane.
“Compared to probiotics, which ‘seed’ the gut with beneficial bacteria, and prebiotics, which ‘feed’ those bacteria, binding proteins work in tandem by sustaining a healthy gut and fostering the optimal conditions for a flourishing microbiome,” she said. “Essentially, binding proteins are the missing piece for proactively ensuring a resilient gut.
“Moreover, compared to many other gut health solutions, binding proteins are highly stable and concentrated with a low recommended daily intake, making them convenient to use for manufacturers and consumers alike.”
Bactolife has conducted several pre-clinical studies on binding proteins in gut cell and animal models. In piglets, binding proteins have been shown to support weight gain and healthy weaning, promote gut microbiota diversity and reduce gastrointestinal issues, such as diarrhea. However, their effect on human health has not yet been clinically tested.
Now, with investments from Novo Holdings, Athos, CBIV, EIFO and the Gates Foundation, Bactolife plans to execute its first comprehensive human study program.
“Firstly, we will ensure that binding proteins are well tolerated by a broad range of consumers,” said Søderberg. “When assessing how binding proteins can support a healthy gut, focus will be on regularity, well-being and gut microbiota composition—including abundance of specific harmful metabolites and microbes known to be associated with an unhealthy gut.
“Multiple studies will be initiated to cover benefits for different consumers ranging from the more proactive gut health seekers to those with existing challenges or a generally sensitive gut, an example being consumers using antibiotics who can benefit from gut health support.”
Chasing global regulatory approval
Bactolife is currently in the final stages of submitting its novel food dossier for regulatory approval in Europe. However, with the average wait time for a novel food approval currently sitting at two-and-a-half years, it could be a while until this ingredient hits the shelves.
In the U.S., the company is actively pursuing GRAS (Generally Recognized as Safe) status and aims to have self-affirmed GRAS status for its first two proteins in the coming months.
Once approved, Bactolife expects its binding proteins to be incorporated into a variety of supplement formats, including tablets, capsules and powders, as well as fresh and processed foods and beverages.
