CalciMedica Inc. (Nasdaq: CALC) has entered into a strategic collaboration with clinical trial intelligence company Telperian to integrate advanced artificial intelligence analytics into the analysis of completed clinical trials for Auxora, the company's lead CRAC channel inhibitor compound.
The partnership will leverage Telperian's AI-powered platform to conduct comprehensive analysis of Phase 2 datasets from CalciMedica's completed clinical trials, including the CARPO and CARDEA studies, as well as simulations from third-party trial publications. This analytical approach aims to refine target patient populations and optimize efficacy endpoints for upcoming pivotal trials.
Clinical Development Progress
Auxora, a potent and selective small molecule CRAC channel inhibitor, has been evaluated across multiple efficacy clinical trials targeting acute inflammatory and immunologic illnesses. The compound has demonstrated positive and consistent clinical results and has been well-tolerated in over 350 critically ill patients.
Key completed trials include the Phase 2b CARPO trial (NCT04681066) in patients with acute pancreatitis and accompanying systemic inflammatory response syndrome, and the Phase 2 CARDEA trial (NCT04345614) in patients with severe COVID-19 pneumonia. CalciMedica is currently in discussions with the U.S. Food and Drug Administration regarding final pivotal trial design for Auxora in acute pancreatitis.
The company is also conducting the ongoing Phase 2 KOURAGE trial (NCT06374797) in patients with acute kidney injury with associated respiratory failure, with data expected in early 2026.
AI-Powered Clinical Intelligence
Telperian's platform combines AI, biostatistics, and domain expertise through several key capabilities: an asynchronous review platform for statistical data in regulatory submissions, the ability to leverage historical evidence for design intelligence, novel subtyping methodologies, and deep study design expertise.
The collaboration will apply these tools to provide data-supported insights into the benefits of Auxora treatment across different patient subtypes, identify discernible patterns and treatment benefits, and conduct emulations of historical studies in the critical care space to inform pivotal program planning.
"CARPO and CARDEA are two critical trials contributing to the strong body of evidence supporting Auxora as a potentially transformative treatment for acute inflammatory and immunologic illnesses," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "Telperian's advanced AI engine will be beneficial in the further analysis of these trials, allowing us to dig deeper into the effects of Auxora, to refine our identification and understanding of treatment effects across patient subgroups, and to enhance the design of our pivotal program in AP."
Regulatory Strategy Enhancement
The findings from this AI-powered analysis will support CalciMedica's ongoing regulatory discussions with the FDA as the company advances toward pivotal development of Auxora. The collaboration represents an integration of artificial intelligence into clinical development and regulatory processes.
Rick Landin, co-Founder and Chief Executive Officer of Telperian, noted: "We're thrilled to utilize our transformative AI engine to support CalciMedica in the analysis of completed Auxora clinical trials and of key critical care clinical trials. Our tools will seamlessly automate the data review process, allowing for accelerated, detailed insights into pharmacokinetics and therapeutic effects."
CRAC Channel Inhibition Technology
CalciMedica's proprietary technology targets the inhibition of calcium release-activated calcium channels to modulate immune response and protect against tissue cell injury. This mechanism has potential therapeutic benefits in life-threatening inflammatory and immunologic diseases for which there are currently no approved therapies.
The company's focus on CRAC channel inhibition represents a novel approach to treating acute and chronic inflammatory conditions, with Auxora serving as the lead clinical compound in this therapeutic class.
