Published Date : 15/10/2025
AI tools will allow CalciMedica to analyze Phase 2 datasets to refine the target patient populations and efficacy endpoints for upcoming pivotal trials.
CalciMedica Inc. (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, and Telperian, a clinical trial intelligence company, today announced a collaboration on the integration of Telperian's artificial intelligence (AI) engine into the analysis of clinical trial datasets from completed clinical trials of Auxora™ as well as data set simulations from publications of third-party trials.
Auxora, CalciMedica's lead clinical compound, is a potent and selective small molecule CRAC channel inhibitor being developed for use in patients with acute inflammatory and immunologic illnesses. Auxora has been evaluated in multiple efficacy clinical trials, including the Phase 2b CARPO trial in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS) and the Phase 2 CARDEA trial in patients with severe COVID-19 pneumonia. CalciMedica is currently in discussions with the U.S. Food and Drug Administration (FDA) on a final pivotal trial design for Auxora in AP. Auxora is also currently being evaluated in the Phase 2 KOURAGE trial in patients with acute kidney injury (AKI) with respiratory failure, with data expected in early 2026.
Telperian's platform, powered by AI, biostatistics, and domain expertise, is comprised of its asynchronous review platform for statistical data in regulatory submissions, its ability to leverage historical evidence for design intelligence, its novel subtyping methodologies, and its deep study design expertise. By applying these tools to analyze clinical trial data of Auxora, Telperian will provide deep, data-supported insights into the benefits of treatment with Auxora to different patient subtypes, as well as other discernible patterns and benefits of treatment. Telperian will also apply its platform to conduct emulations of historical studies in the critical care space to determine useful insights for planning a pivotal program for Auxora. These findings will be used to support CalciMedica in the Company's regulatory discussions.
Q: What is Auxora™?
A: Auxora™ is a potent and selective small molecule CRAC channel inhibitor being developed by CalciMedica for use in patients with acute inflammatory and immunologic illnesses.
Q: What is the purpose of the collaboration between CalciMedica and Telperian?
A: The collaboration aims to integrate Telperian's AI engine into the analysis of clinical trial datasets of Auxora™ to refine patient populations and efficacy endpoints for upcoming pivotal trials.
Q: What are some of the clinical trials Auxora™ has been evaluated in?
A: Auxora™ has been evaluated in the Phase 2b CARPO trial for acute pancreatitis, the Phase 2 CARDEA trial for severe COVID-19 pneumonia, and the ongoing Phase 2 KOURAGE trial for acute kidney injury with respiratory failure.
Q: What is Telperian's platform used for?
A: Telperian's platform, powered by AI, biostatistics, and domain expertise, is used to automate the data review process, provide detailed insights into pharmacokinetics and therapeutic effects, and leverage historical evidence for design intelligence.
Q: What is the expected outcome of this collaboration?
A: The expected outcome is to enhance the design of pivotal trials for Auxora™ by providing deep, data-supported insights into treatment effects across different patient subgroups and other discernible patterns.