Advanced HMOs: Inbiose applies for FDA GRAS approval of four new ingredients

07 Jul 2021 --- Biotech company Inbiose has applied for Generally Recognized as Safe (GRAS) approval by the US Food & Drug Administration (FDA) for four of its human milk oligosaccharides (HMOs).

“The four HMOs we submitted for regulatory approval are advanced HMOs that go beyond the current standard HMO 2-fucosyllactose (2’FL) that is currently added to infant formula milk,” Dr. Wim Soetaert, CEO and chairman of Inbiose, tells NutritionInsight.

The HMOs submitted are 6’-Sialyllactose (6’SL), 3-Sialyllactose (3’SL), Lacto-N-Tetraose (LNT) and Lacto-N-neoTetraose (LNnT). 

“2FL is the most abundant HMO in human milk but it is also the simplest one. Our advanced HMOs have significantly more complex structures and also belong to a different class of HMOs, namely the acidic sialylated HMOs and neutral non-fucosylated HMOs,” Soetaert adds.

Inbiose will also file for Novel Food approval of these HMOs by the European Commission in the coming weeks and is preparing a global regulatory roll-out. 

Closer composition to human milk
Inbiose has been developing a wide range of human-identical milk oligosaccharides that can be industrially produced by sustainable fermentation processes. 

 Professor Wim Soetaert, CEO and chairman of Inbiose. Human milk contains over 100 different HMOs and mimicking this structural HMO complexity is a key target of Inbiose. 

“We are now making it possible to come closer to the natural HMO composition of human milk,” Soetaert says.

Inbiose expects to obtain regulatory approval for these HMOs in 2022 and is currently organizing its industrial production for timely deliveries to customers in infant nutrition, dietary supplements and functional food and beverages. 

HMOs are the newest ingredients for premium infant formula, and industry watchers expect this market to reach €500 million (US$591 million) by 2025 and grow further to well over €1 billion (US$1.2 billion), the company says. 

Beyond infant nutrition
Scientific studies have demonstrated that HMOs may play an important role as bio-active ingredients for improved immunity, gut health, learning ability and brain health of the general population.

Soetaert asserts that the company is also targeting adult nutrition as “it is increasingly clear that the positive health benefits of HMOs for babies also apply to the general population.” 

“The positive effects of HMOs on cognition are becoming increasingly clear and this is particularly relevant for elder people where cognition becomes a key factor for healthy aging,” Soetaert notes.

Key health benefits
Natural evolution has been very effective in finding solutions to promote the health of babies, Soetaert continues.

“As a result human milk contains a wide variety of HMOs with very different health benefits. These beneficial effects are varied but have been well studied,” he adds.

The HMOs submitted for GRAS approval are 6’SL, 3’SL, LNT and LNnT.  HMOs have a prebiotic effect, which is the growth stimulation of beneficial bacteria in the infant gut, particularly Bifidobacterium.

Moreover, they have an antimicrobial effect. “HMOs can ward off many pathogenic bacteria and viruses and thus protect the baby against infectious diseases.”

Modulating and training the immune system of the baby is another benefit. “The building of a healthy immune system of a baby happens primarily during infancy and these effects are felt throughout the rest of their life.”

Lastly, they promote brain development and cognition. “Certain HMOs are critical for brain development of the baby. Whereas most studies in the past have relied on animal testing, some recent articles from Nestlé and others have shown that for instance 3’SL effectively promotes the language learning ability in children,” Soetaert explains.

Inbiose’s journey to market
Inbiose is a Belgium-based biotech company, originally a spinoff from the University of Ghent. It is focused on the research, development and commercialization of specialty carbohydrates, including HMO. 

“Our unique proprietary technology platform GlycoActives enables cost-effective manufacturing of a wide range of specialty carbohydrates by sustainable fermentation processes,” Soetaert says.

In 2016, DuPont Nutrition & Health announced a joint development and licensing agreement with Inbiose. The agreement covered exclusive rights to selected fucosylated HMOs, including 2’-fucosyllactose. 

Two years later, DuPont and Inbiose gained regulatory approval of their first HMO ingredient for infant formula in the European market. 

HMOs are proliferating in supplement applications with US-based nutrition start-up Layer Origin Nutrition recently launching seven supplements containing HMOs.

Meanwhile, DSM is putting HMOs in the spotlight with new supplement concepts as research findings are linking them to wider gut health and immunity industry trends. 

By Kristiana Lalou