The Company's randomized, double-blind, placebo-controlled Phase 2b trial evaluating Auxora™ for the treatment of acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS). The trial established a dose response for Auxora across multiple endpoints, identified both the target patient population and the likely drug dose for a pivotal trial, and re-affirmed Auxora's safety profile and tolerability as seen in prior clinical trials.
"With these results, CARPO has added significantly to the body of evidence showing Auxora's potential as an effective treatment for critically ill patients with acute inflammatory disease and warrants advancing our drug in both AP and acute kidney injury," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "We plan to move quickly towards initiating our Phase 3 trial in AP and are eager to engage with the FDA to discuss our trial plans once we have all the data from CARPO. We look forward to unlocking Auxora's potential to treat these patients who have few treatment options."
"There are currently no drugs for the treatment of AP and the CARPO data show a benefit in multiple endpoints, supporting the need for Auxora," said Joseph Miller, M.D., Clinical Associate Professor of Emergency Medicine at Henry Ford Health and Michigan State University and Associate Director Emergency Care Research at Henry Ford Health and a principal investigator in the CARPO trial. "AP is one of the costliest gastrointestinal diseases for hospitals due to prolonged lengths of stay for severe patients. By reducing the occurrence of severe organ failure and extended hospital stays, Auxora may provide significant benefits to patients with AP and to the health care system and should be welcomed by clinicians and hospitals."
About CalciMedica:
CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic diseases. CalciMedica's proprietary technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases for which there are currently no approved therapies. CalciMedica's lead product candidate Auxora™, has demonstrated positive and consistent clinical results in multiple completed efficacy clinical trials. CalciMedica has completed a Phase 2b trial (called CARPO – NCT04681066) in AP with SIRS and a Phase 2b trial (called CARDEA – NCT04345614) in COVID pneumonia patients, continues to support the ongoing Phase 1/2 AIPT study (called CRSPA – NCT04195347), with data expected in 2025, and has initiated its Phase 2 study (called KOURAGE – NCT06374797) in AKI with associated AHRF with data expected in 2025. CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, CA.
For more information, please visit www.calcimedica.com.
