Designing a Clinical Development Path for Anti- Fibrotic Therapy in CKD to Establish Early Proof-of- Concept & De-Risk Phase II
1:30 pm - Thursday 18th March 2027
- Advancing MTX-439 from healthy-volunteer Phase I into kidney disease patients to translate a novel anti-fibrotic mechanism into a clinically relevant CKD development program and define the exposure required for therapeutic activity
- Prioritizing diabetic kidney disease and other populations with persistent fibrotic progression despite treatment of the underlying disease to target residual kidney damage where anti-fibrotic intervention could help delay dialysis or transplantation
- Integrating SMOC2, fibrosis biomarkers and non-proteinuric development endpoints into Phase II design to identify patients most likely to benefit, establish proof-of-concept earlier and address the uncertainty around how to develop therapies that do not primarily act at the glomerulus