CalciMedica Partners With Telperian to Leverage AI Technology for Auxora Clinical Data Analysis

In a strategic move to accelerate drug development, CalciMedica Inc. (Nasdaq: CALC) has joined forces with Telperian, a clinical trial intelligence firm, to harness advanced artificial intelligence capabilities for analyzing its therapeutic pipeline. The partnership focuses on deeper examination of Auxora™, the company’s lead candidate targeting inflammatory and immunologic conditions, with particular attention to optimizing patient selection and clinical endpoints for future regulatory submissions.

What This Collaboration Means

The partnership leverages Telperian’s AI-powered statistical platform to dissect existing trial data from CalciMedica’s completed studies. This technological integration enables automated pattern recognition across patient populations, potentially identifying subgroups most likely to benefit from Auxora treatment. Rather than relying on traditional manual analysis methods, the AI engine will streamline data review processes—a capability that could reshape how clinical evidence is synthesized in regulatory discussions with the FDA.

“The combination of our trial data with Telperian’s intelligence tools creates a pathway to extract insights we might otherwise miss,” explains Rachel Leheny, Ph.D., CEO of CalciMedica. “This collaboration strengthens our ability to design more targeted pivotal programs while supporting ongoing FDA engagement on Auxora development.”

CalciMedica’s Clinical Portfolio

CalciMedica has invested years developing Auxora, a selective inhibitor of CRAC channels designed to suppress excessive immune responses in life-threatening conditions. The compound has moved through multiple efficacy studies:

Completed trials include the Phase 2b CARPO study in acute pancreatitis patients with systemic inflammatory response syndrome, and the Phase 2 CARDEA trial evaluating Auxora in severe COVID-19 pneumonia. Both demonstrated clinical benefit with favorable tolerability profiles across more than 350 critically ill patients.

Currently underway is the Phase 2 KOURAGE trial examining Auxora in acute kidney injury patients experiencing respiratory failure—data delivery anticipated in early 2026. Meanwhile, CalciMedica is actively working with FDA officials to finalize the design of pivotal-stage trials in acute pancreatitis, representing a critical inflection point for the program.

The AI Advantage in Drug Development

Telperian’s platform goes beyond standard statistical analysis. The system combines machine learning with biostatistical expertise and domain knowledge to conduct what amounts to computational “trial emulations”—examining how historical critical care studies might inform Auxora’s development strategy. This approach reduces the traditional bottleneck where data preparation and statistical review consume months of manual effort.

“Clinical trial statistics has been a labor-intensive, error-prone bottleneck for too long,” notes Rick Landin, co-founder and CEO of Telperian. “Our AI transforms this from a manual constraint into an intelligent engine. For CalciMedica’s program, this means accelerated insights into pharmacokinetics and therapeutic mechanisms across diverse patient subtypes.”

Strategic Importance

The timing of this collaboration underscores CalciMedica’s commitment to evidence-based development. By extracting granular insights from CARPO and CARDEA datasets, the company gains intelligence to refine patient identification strategies and clinical efficacy measures—inputs crucial for designing pivotal trials that satisfy regulatory requirements while maximizing success probability.

These findings will feed directly into CalciMedica’s regulatory strategy, potentially strengthening FDA discussions around Auxora’s path forward. For a clinical-stage biotech, such data-driven optimization can be the difference between trial success and costly setbacks.

About the Companies

CalciMedica focuses on CRAC channel inhibition as a therapeutic mechanism for inflammatory and immunologic diseases with limited treatment options. The company’s platform technology modulates immune response while protecting tissue from injury—addressing conditions where current approved therapies fall short. Auxora represents the lead program emerging from this approach, with robust clinical feasibility demonstrated across multiple patient populations.

Telperian provides what it calls “Statistical Lifecycle solutions”—automation tools that streamline clinical trial design, analysis, and regulatory submissions. The platform enables asynchronous workflows between sponsors, contract research organizations, and regulatory bodies, replacing sequential handoffs with intelligent automation and historical evidence integration.

This announcement contains forward-looking statements regarding CalciMedica’s clinical development plans, the timing of trial data releases, the potential therapeutic benefits of Auxora, and Telperian’s platform capabilities. Actual results may differ materially due to uncertainties, regulatory risks, trial outcomes, safety considerations, market factors, and financial constraints. Investors should review CalciMedica’s SEC filings for comprehensive risk disclosures.