Research & Development Landscape for Maternal Enteric Microbiome Medicines (2000-2023)

Changes in the composition of the maternal gut microbiome during pregnancy are normal and are driven by physiological immune and inflammatory changes. However, as can happen at any stage in life, the maternal gut microbiome is susceptible to imbalance. Maternal environmental enteric dysfunction (EED) describes this imbalance and the associated inflammation in the gut, which may lead to altered maternal metabolism, decreased nutrient absorption and impaired barrier function. Maternal environmental enteric dysfunction (EED) can have significant direct and indirect impacts on pregnancy and neonatal outcomes.

While some medicines can effectively prevent and treat pregnancy-related conditions such as preeclampsia and preterm birth, nearly all are off-label. Many have undesirable side effects, limited efficacy, or target only the isolated, downstream effects of the condition. Additionally, while there are candidates under development for these conditions in the R&D pipeline, new and transformative medicines continue to be a distant prospect. With increasing evidence of the key role that maternal EED plays in the development and progression of major pregnancy-related conditions, as well as in determining neonatal outcomes, attention is slowly turning to upstream interventions that target the maternal enteric microbiome. Incorporating these interventions during pregnancy and lactation presents a promising opportunity to impact and improve maternal and infant health outcomes, particularly in LMICs.