CalciMedica has announced the completion of patient enrollment for its Phase IIb CARPO clinical trial, which is evaluating the efficacy of Auxora in treating acute pancreatitis.
A new therapy from CalciMedica, Auxora is a potent and selective inhibitor of Orai1-containing calcium release-activated calcium (CRAC) channels.
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It is being developed to treat acute inflammatory and immunologic illnesses, with a focus on its potential benefits for patients suffering from acute pancreatitis.
The CARPO trial is a global, double-blind, randomised, placebo-controlled, dose-ranging study designed to determine the dose-response and efficacy of Auxora in patients with acute pancreatitis and accompanying systemic inflammatory response syndrome (SIRS).
Patients in the trial have been randomised into four groups to receive varying doses of Auxora or a placebo intravenously every 24 hours for three doses.
The CARPO protocol mandates a 30-day treatment and observation period for patients, with the company set to report topline results later this quarter.
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By GlobalDataCalciMedica CEO Rachel Leheny said: “We are a significant step closer to delivering a potential treatment for acute pancreatitis, for which there is currently no approved therapy. We look forward to sharing the results of this clinical trial in the coming weeks once the last patient has finished treatment and the data have been analysed.”
In February, the US Food and Drug Administration approved CalciMedica’s investigational new drug application to advance Auxora to a Phase II study.
The KOURAGE trial is designed to analyse the ability of Auxora to treat acute kidney injury with associated acute hypoxemic respiratory failure.
