Caelus has built a platform to identify, validate, protect, manufacture and commercialise precisely defined next-generation microbial strains for cardio-metabolic health. The platform brings together microbiome science, human evidence, regulatory expertise, intellectual property, process development and partner-led market access.
The platform’s lead strain, Anaerobutyricum soehngenii CH106 (A. soehngenii), is the first live commensal gut bacterium of its kind to receive a positive safety opinion from the European Food Safety Authority (EFSA) under the EU Novel Food Regulation. Caelus’s GRAS notification for A. soehngenii resulted in FDA-notified GRAS status (GRN 1065), a testimony of the excellent safety profile and the rigour of the underlying data that Caelus presented.
Our portfolio consists of naturally occurring gut bacteria with distinct roles in pathways relevant to cardio-metabolic health. Several produce butyrate, a short-chain fatty acid involved in glucose metabolism, insulin signalling and intestinal-barrier function. Each strain is precisely characterised and developed in its own right with its own evidence and development pathway.
A. soehngenii is a naturally occurring, butyrate-producing gut bacterium and the most extensively studied strain in the Caelus portfolio. Four human clinical trials published in high-quality peer-reviewed journals have evaluated the strain in metabolic syndrome, prediabetes and type 2 diabetes. Across these studies, administration was safe and well tolerated. Individual studies reported improvements in insulin sensitivity, glycaemic variability and overall glycaemic control, HbA1c and blood pressure, while a mechanistic study using direct duodenal administration showed increased intestinal GLP-1 production.
Intestinimonas butyriciproducens is a butyrate producer with a distinctive metabolic pathway: it converts fructoselysine, a compound formed when dietary sugars react with proteins, into butyrate. Research to date links the strain to markers relevant to body weight, triglycerides, glucose metabolism and advanced glycation end-products. Caelus is advancing the strain within its platform.
Anaerostipes rhamnosivorans metabolises complex sugars through a distinctive inositol-based pathway. Preclinical research points to potential relevance in early metabolic dysfunction and the progression towards type 2 diabetes. Its differentiated biology makes it complementary to the portfolio, and the strain is being further developed within the Caelus platform.
Mitsuokella is an earlier-stage research species within the Caelus portfolio. It is being studied for its role in metabolic pathways relevant to cardio-metabolic health and illustrates the broader discovery depth of the platform.
Behind every strain sits a reproducible development and manufacturing pathway covering fermentation, preservation, formulation, analytical testing and quality control. This allows Caelus to provide partners not only with scientific and intellectual property support, but also with a consistent microbial ingredient designed for scalable incorporation into finished products.
