Next-gen probiotic gets FDA no objection GRAS

02-May-2023 - Last updated on 26-Jun-2023 at 08:43 GMT

Netherlands-based Caelus Health has received a letter of no objection from the US FDA regarding the GRAS (generally recognized as safe) status for a next-generation microbe.

The company received the letter, dated April 14, to its GRAS notification (GRN 1065) for the use of Anaerobutyricum soehngenii strain CBS 145175 (A. soehngenii CBS 145175, previously referred to as E. hallii) in sports drinks and fluid replacement drinks; ready-to-eat breakfast cereals; cereal, granola, “energy”, protein, and meal replacement bars; ice cream; plain fermented milk; yogurt (including non-dairy yogurt); nut spreads; and chocolate at a maximum level of 1.0 × 1010 total fluorescent unit (TFU)/serving.

Luc Sterkman, MD, CEO of Caelus commented: “The endorsement by the FDA of the safety of the A. soehngenii strain as an ingredient marks the completion of the development of the product. This enables the global commercialization of products based on the patent-protected strain of A. soehngenii with an imminent start in the US.”

Sterkman told NutraIngredients-USA that the plan is to “first fully focus on the launch in the US; seeking regulatory approval in other markets comes later. However, the Novel Food procedure with EFSA has already been initiated.”

Health indications

A. soehngenii CBS 145175 is an anaerobic butyrate-producing strain that promotes cardio-metabolic health, stated the company in a release.

Data from a pilot study, published in npj Biofilms and Microbiomes in 2020, indicated that four weeks of A. soehngenii supplementation improved peripheral insulin sensitivity, and this was “accompanied by an altered microbiota composition and a change in bile acid metabolism”.

This was followed by a mechanism of action study, which was published in 2021 in Gut.

Two more clinical trials of a product based on A. soehngenii in pre-diabetes and in Type 2 diabetes were also recently completed successfully. The new studies were performed with a product based on gastro-resistant capsules, which are stable at room temperature for over two years.

Sterkman confirmed that the manuscript on the clinical trial of A. soehngenii in Type 2 diabetes was performed at the Amsterdam University Medical Center (AUMC). The researchers have prepared a manuscript that has recently been submitted to a high impact factor journal, he told us. The clinical development was performed in close cooperation with team of Prof. Max Nieuwdorp, a co-founder of Caelus Health with Prof Willem M de Vos.

The other clinical study, which focused on people with pre-diabetes, was performed in close cooperation with Atlantia in Cork. They have just completed the Clinical Study Report. A manuscript on the data of this study is scheduled to be submitted in July

Prof de Vos stated: “A. soehngenii CBS 145175 is capable of converting sugars as well as lactate and acetate into butyrate and hence is involved in important trophic chains in the human gut. This strain is the first next-generation beneficial microbe isolated from the human gut that has received this No Objections Letter from the FDA, opening the way for broader access to the product.”

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