CalciMedica and Telperian Announce Collaboration to Integrate Innovative Artificial Intelligence Engine to Analysis of Clinical Trials of Auxora™
Rhea-AI Summary
CalciMedica (NASDAQ: CALC) announced a collaboration with Telperian to integrate Telperian's AI engine into analysis of completed Phase 2 clinical trial datasets for Auxora, including the CARPO (acute pancreatitis with SIRS) and CARDEA (severe COVID-19 pneumonia) trials.
Telperian will apply AI, biostatistics, subtyping, and historical-study emulations to refine target patient subgroups, efficacy endpoints, and to generate data-supported insights to support CalciMedica's regulatory discussions with the FDA for a final pivotal trial design in acute pancreatitis. Auxora is also being evaluated in the Phase 2 KOURAGE trial, with data expected in early 2026.
Positive
- Integration of AI to analyze completed Phase 2 CARPO and CARDEA datasets
- Findings intended to support FDA discussions on pivotal trial design
- Planned emulations of historical critical care studies to inform trial planning
- Phase 2 KOURAGE data expected early 2026
Negative
- Final pivotal trial design for Auxora is not yet finalized and remains under FDA discussion
Insights
Collaboration uses AI to mine Phase 2 data and simulations to refine pivotal trial design for Auxora ahead of regulatory talks.
CalciMedica will apply Telperian's AI, biostatistics, and subtyping tools to reanalyze completed Phase 2 datasets (CARPO, CARDEA) and simulated datasets to identify treatment effects by patient subgroup and inform endpoint selection; those outputs will feed ongoing discussions with the FDA about a final pivotal design.
Key dependencies include the quality and completeness of the Phase 2 datasets and the transparency of Telperian's methods; analytic results must map cleanly to prespecified, regulator‑acceptable endpoints to influence a pivotal plan. Watch for the deliverables and methods summary, and for the
AI tools will allow CalciMedica to analyze Phase 2 datasets to refine the target patient populations and efficacy endpoints for upcoming pivotal 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
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.
"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. We are eager to review the findings and share them with the FDA as we discuss pivotal development of Auxora."
Rick Landin, co-Founder and Chief Executive Officer of Telperian, said, "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. This collaboration represents another critical step forward in the integration of artificial intelligence into the clinical development and regulatory processes, demonstrating the inherent compatibility between them."
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 and been well-tolerated in over 350 critically ill patients dosed. CalciMedica has announced data for a Phase 2b trial (called CARPO – NCT04681066) in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS) and for a Phase 2 trial (called CARDEA – NCT04345614) in patients with COVID pneumonia. The Company is currently conducting a Phase 2 trial (called KOURAGE – NCT06374797) in patients with acute kidney injury (AKI) with associated respiratory failure, with data expected in early 2026. For more information, please visit www.calcimedica.com.
About Telperian
For drug developers frustrated with the slow, costly, and error-prone clinical trial design, data preparation, and regulatory review, Telperian, a clinical trial intelligence company, delivers Statistical Lifecycle solutions that provide automation and optimization of the design, analysis, and regulatory submission of clinical trials.
Unlike the standard process of trial design through assumptions based on limited information, labor-and-time intensive statistical programming, and the linear synchronous handoffs between sponsors, CROs, and regulatory agencies, Telperian transforms clinical trial statistics from a slow, manual bottleneck into an automated intelligence engine—through 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—accelerating drug development, reducing costs, and improving the odds of success.
Forward-Looking Statements
This communication contains forward-looking statements which include, but are not limited to CalciMedica's planned and ongoing clinical trials and the timing, design, and the release of data from those trials including its Phase 2 KOURAGE trial of Auxora in AKI with associated respiratory failure in early 2026; the potential of CalciMedica's proprietary technology to provide therapeutic benefits in acute and chronic inflammatory and immunologic diseases; the ability of Telperian to provide data-supported insights into the benefits of treatment with Auxora; and the ability of Telperian's AI powered platform to conduct emulations of historical studies in the critical care space to determine useful insights for planning a pivotal program for Auxora. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. CalciMedica's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances, including but not limited to risks and uncertainties related to: the impact of fluctuations in global financial markets on CalciMedica's business and the actions it may take in response thereto; CalciMedica's ability to execute its plans and strategies; the ability to obtain and maintain regulatory approval for Auxora; results from clinical trials or preclinical studies may not be indicative of results that may be observed in the future; potential safety and other complications from Auxora; the scope, progress and expansion of developing and commercializing Auxora; the size and growth of the market therefor and the rate and degree of market acceptance thereof; economic, business, competitive, and/or regulatory factors affecting the business of CalciMedica generally; CalciMedica's ability to protect its intellectual property position; the impact of government laws and regulations; and CalciMedica's financial position and need for additional capital. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" in CalciMedica's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the Securities and Exchange Commission (SEC) on August 12, 2025, and elsewhere in CalciMedica's subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time and available at www.sec.gov. These documents can be accessed on CalciMedica's web page at ir.calcimedica.com/financials-filings/sec-filings. The forward-looking statements contained herein are made as of the date hereof, and CalciMedica undertakes no obligation to update them after this date, except as required by law.
CalciMedica Contact Information
Kevin Murphy
calcimedia@argotpartners.com
(212) 600-1902
Telperian Contact Information
Samantha Drake
sdrake@telperian.com
(919) 667-6574
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SOURCE CalciMedica, Inc.
FAQ
What did CalciMedica (CALC) announce on October 14, 2025 about Auxora?
Which Auxora trials will Telperian analyze for CalciMedica (CALC)?
How will Telperian's AI work support CalciMedica's (CALC) regulatory plans?
When is additional Auxora clinical data expected that could affect CALC's development timeline?
Does the announcement confirm a finalized pivotal trial for Auxora (CALC)?
