Auxora™ Phase 2b CARPO Trial Completes Enrollment

CalciMedica, a biopharmaceutical firm in the clinical stage, has successfully completed the enrollment of 216 participants for its Phase 2b CARPO trial. This trial is investigating the effects of Auxora™, a CRAC channel inhibitor, on acute pancreatitis (AP). The company is dedicated to developing new treatments for inflammatory and immunological conditions and has reached a milestone with the completion of patient enrollment.

The CARPO trial is a global, randomized, double-blind, and placebo-controlled study designed to determine the optimal dosage and effectiveness of Auxora™ in treating AP, which often presents with systemic inflammatory response syndrome (SIRS). Participants have been divided into four groups to receive varying doses of Auxora™ or a placebo. The protocol mandates a 30-day treatment and observation period, with preliminary results expected to be released in the second quarter of 2024.

Auxora™, CalciMedica's leading compound, is a potent and selective inhibitor of CRAC channels, which are implicated in various cell types and may contribute to inflammatory diseases. The compound is under evaluation in several clinical trials, including CARPO for AP with SIRS, a Phase 2 trial for acute kidney injury (AKI) with acute hypoxemic respiratory failure (AHRF) named KOURAGE, and a Phase 1/2 trial for pediatric patients with asparaginase-induced pancreatic toxicity (AIPT) known as CRSPA. There are no approved treatments currently available for AP, AKI, or AIPT.

AP is a severe and potentially fatal condition that can result in cell death, systemic inflammation, and organ failure. In the United States, approximately 275,000 hospitalizations occur due to AP annually, with around 40% of cases involving SIRS, which is associated with more severe outcomes. CalciMedica's CARPO trial details can be found on clinicaltrials.gov with the identifier NCT04681066.

CalciMedica is leveraging its proprietary technology to target CRAC channel inhibition, aiming to modulate the immune response and mitigate tissue damage. The company's flagship product, Auxora™, has shown promising results in previous trials, and CalciMedica is also exploring its potential for treating other acute conditions, such as acute respiratory distress syndrome.

The company, founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, is headquartered in La Jolla, California, and is committed to advancing treatments for life-threatening diseases without current approved therapies. CalciMedica is eagerly anticipating the CARPO trial results, which will be a significant step towards potentially offering a new treatment option for AP.