Clinical-stage pharmaceutical company Cirius Therapeutics Incannounced on Tuesday a planning grant from the Gates Foundation to advance the development of CIR-0602K as a potential postpartum therapeutic for women with a history of gestational diabetes mellitus (GDM).

The company says that this planning grant can potentially inform a multi-stage development programme to generate scientific and clinical evidence supporting CIR-0602K for postpartum use in women who develop GDM during pregnancy. The initial grant supports a planning and preparation phase for examining potential exposure of CIR-0602K in breast milk, with the objective of enabling future clinical studies in women immediately postpartum, subject to outcomes and regulatory feedback.

Outputs from this planning phase will potentially inform the design, regulatory expectations and execution of subsequent clinical studies, including trials conducted in LMIC settings. As part of this planning phase, Cirius says that it will also work with Certara, a global company involved in model-informed drug development, bringing specialised expertise in maternal-foetal and lactation modelling. Using the Simcyp Simulator, Certara scientists can predict drug exposure in breastfeeding mothers and infants, populations that are historically under-represented in clinical research.

CIR-0602K is an orally administered MPC inhibitor that has been evaluated in multiple Phase 2 studies across cardiometabolic indications. If future studies demonstrate safety and efficacy in the postpartum setting, the therapy could offer a practical and scalable intervention to reduce progression to type 2 diabetes, kidney disease and other chronic metabolic diseases following GDM.

According to Cirius, the compound's profile may be particularly advantageous for use in resource-limited settings. Cirius has committed to managing all project outputs in alignment with the Gates Foundation's Global Access principles, ensuring early consideration of affordability, accessibility, and relevance for LMIC populations.