CalciMedica: Auxora Calcium Channel Inhibitor Improves Time to Solids in Patients with Pancreatitis

1. Patients with pancreatitis on high-dose Auxora showed a 2.1-day improvement in time to solid food tolerance compared to the placebo group.
2. Auxora was well tolerated with none of the 34 treatment-emergent serious adverse events deemed drug-related.

The Latest

CARPO is a recent phase 2b international, randomized, double-blind, placebo-controlled, dose-ranging trial designed by CalciMedica to determine dose-response and efficacy of Auxora in patients with acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS). The trial enrolled 216 patients with AP with accompanying SIRS. Patients received either a low dose (0.5 mg/kg), medium dose (1mg/kg), high dose (2mg/kg), or placebo by intravenous injection every 24 hours for 3 doses. Patients on the lowest dose showed a 1.5-day improvement compared to the placebo group in terms of when they could tolerate solid food. The effect was enhanced to a 1.9-day improvement and 2.1-day improvement in the high-dose and medium-dose drug cohorts, respectively. The drug was generally well tolerated with a similar number of adverse events seen in the drug cohorts compared to the placebo group.

Physician’s Perspective

Inflammation of the pancreas can be a life-threatening condition. There are an estimated 275, 000 hospitalizations for AP annually in the United States. Approximately 40% of these cases present with SIRS, which is a predictor for further morbidity and mortality. Organ failure is the cause of much of the mortality seen in AP. However, there are currently no approved therapies for AP. Through this trial, Auxora has shown to be an effective treatment for critically ill patients with not only AP but also other acute inflammatory diseases such as acute kidney injury and asparaginase-induced pancreatic toxicity.

Molecular Targets

Calcium release-activated channels (CRACs) are found on many cell types in the body including immune system cells, endothelial cells, and pancreatic acinar cells. Aberrant activation of CRACsplay a key role in the pathophysiology of acute and chronic inflammatory syndromes such as AP. Auxora is a potent and selective small molecule inhibitor of Orai1-containing CRACs which works by protecting pancreatic acinar cell death and rapidly reducing inflammatory responses that manifest clinically as SIRS.

Company History

CalciMedia is a clinical-stage biopharmaceutical company headquartered in La Jolla, California focused on developing novel CRAC channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses. The biotech company has already tested Auxora in COVID-19 patients during the pandemic and has another phase 2 trial ongoing in acute kidney injury. They are also conducting a phase 1 of 2 trial in children with asparaginase-induced pancreatic toxicity as a side effect of leukemia treatment.

Further Reading: https://ir.calcimedica.com/news-releases/news-release-details/calcimedica-announces-positive-topline-data-phase-2b-carpo-trial

©2024 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.