CalciMedica Secures FDA Path for Acute Pancreatitis Drug Trial

The trial will focus on preventing new-onset severe respiratory failure, which federal regulators and the company identified as the primary endpoint. Secondary measures include tracking multi-organ failure and the time required for a medically indicated discharge. By prioritizing these clinical outcomes, the company aims to move toward a well-powered Phase 3 program that reflects the realities of how the disease presents in hospitals.

To refine patient selection, CalciMedica will investigate whether elevated lactate dehydrogenase (LDH) can serve as an enrichment marker. Previous exploratory data from the CARPO trial suggested that higher LDH levels correlate with both tissue injury and an increased risk of severe respiratory complications. Sudarshan Hebbar, Chief Medical Officer at CalciMedica, noted that this strategy provides a path to validating a treatment for a condition that accounts for roughly 300,000 hospitalizations annually in the United States. Timothy B. Gardner, Director of Pancreatic Disorders at Dartmouth–Hitchcock Medical Center, emphasized that the lack of a standardized endpoint framework has historically hampered progress in the field, making this collaboration a significant step toward defining a practical clinical path.