Auxora - (CARPO)

July 29, 2026: CalciMedica, Inc. (NASDAQ: CALC) reported FDA alignment (Type C Focused Meeting) on the Phase 2b trial design for Auxora (zegocractin), an IV CRAC channel inhibitor, in acute pancreatitis (AP) as part of a planned registration program. FDA agreed that new-onset severe respiratory failure will be the Phase 2b primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints. FDA and the company also aligned on using Phase 2b to confirm patient selection criteria and inform the Phase 3 endpoint, with additional Phase 3 design discussions planned.

The company will prospectively assess elevated lactate dehydrogenase (LDH) as a potential enrichment marker to identify AP patients at higher risk of new-onset severe respiratory failure, supported by exploratory CARPO trial analysis; in CARPO, LDH >240 U/L was associated with higher median IL-6 (134 vs 49 pg/mL; p=0.004). CalciMedica said CARPO showed a 100% reduction in new-onset severe respiratory failure with medium/high Auxora doses vs placebo.

Other pipeline timing: Auxora PAH Phase 1b proof-of-concept data are anticipated mid-2027; CM5480 oral CRAC inhibitor IND submission is expected mid-2027.