CalciMedica's inhibitor aids pancreatitis patients in eating solids sooner

CalciMedica has announced promising results from its phase 2b CARPO trial, which enrolled 216 patients suffering from acute pancreatitis (AP) and systemic inflammatory response syndrome (SIRS). This trial tested the effectiveness of Auxora, a calcium release-activated calcium channel inhibitor, in reducing the time it took for patients to tolerate solid food again.

Patients in the trial were divided into groups receiving either 2 mg/kg, 1 mg/kg, or 0.5 mg/kg doses of Auxora or a placebo, administered intravenously every 24 hours for a total of three doses. Notably, 43% of participants were identified as having hyperinflamed pancreatitis. The trial's primary endpoint focused on this subgroup, revealing that even the lowest dose of Auxora led to a 1.5-day reduction in the time required before patients could consume solid food compared to the 4.7 days needed for those on placebo.

Further analysis demonstrated that higher doses of Auxora resulted in even more significant improvements. Patients on the medium dose experienced a 2.1-day reduction, while those on the highest dose saw a 1.9-day reduction in time to solid food tolerance. Despite the positive outcomes in the hyperinflamed subgroup, patients without hyperinflammatory AP did not show a significant benefit from the drug, as they generally tolerated solid food relatively quickly.

CalciMedica emphasized that the CARPO trial met its objectives by demonstrating a dose response in the time to solid food tolerance and various other clinical endpoints. Rachel Leheny, Ph.D., CEO of CalciMedica, highlighted the importance of these results, stating that they provide strong evidence of Auxora's potential as a treatment for critically ill patients with acute inflammatory diseases. The company plans to advance the drug into a phase 3 trial for acute pancreatitis and is eager to discuss their plans with the FDA once all data from the CARPO trial is available.

Additionally, the trial showed a statistically significant dose response in reducing severe organ failure. Specifically, 9.4% of patients in the placebo group experienced organ failure, while 9.6% of those receiving the lowest dose of Auxora experienced similar outcomes. In contrast, only 3.6% and 3.8% of patients in the medium- and high-dose groups, respectively, suffered from organ failure.

Auxora was well tolerated across the trial, with no treatment-emergent serious adverse events (TESAEs) reported in the medium- and high-dose groups being deemed drug-related. There was only one TESAEs in the low-dose group that was considered drug-related. In the placebo group, 20 TESAEs were documented. The trial also recorded treatment-emergent adverse events leading to the death of one patient in the placebo group and one in the medium-dose group, with no deaths in the high- and low-dose groups.

Beyond this trial, CalciMedica has explored Auxora in other contexts, including testing it on COVID-19 patients during the pandemic. The company is currently conducting a separate phase 2 trial focusing on acute kidney injury and a phase 1/2 trial for children experiencing pancreatic toxicity induced by asparaginase, a side effect of leukemia treatment.

With the promising data from the CARPO trial, CalciMedica is optimistic about the future of Auxora as a treatment for acute inflammatory diseases and looks forward to progressing to the next stages of clinical development.