CalciMedica Inc. announced the publication of a manuscript in the American Journal of Nephrology (AJN) detailing the design and rationale of its Phase 2 KOURAGE trial. This trial evaluates Auxora, the company's lead candidate, in acute kidney injury (AKI) with respiratory failure. The publication includes preclinical data and a post-hoc analysis from the Phase 2 CARDEA trial, reinforcing the scientific basis for Auxora's development.
The manuscript highlights preclinical evidence where Auxora significantly increased glomerular filtration rate (GFR) and prevented mortality in ischemia/reperfusion models of AKI in rats. Furthermore, a post-hoc analysis of a subgroup of 38 CARDEA trial patients with AKI at enrollment showed a 62.7% relative reduction and a 29.3% absolute reduction in mortality for Auxora compared to placebo. Specifically, 7 out of 15 (46.7%) placebo patients died by day 30 and day 60, versus 4 out of 23 (17.4%) Auxora patients.
The KOURAGE trial is a randomized, double-blind, placebo-controlled study expected to enroll approximately 150 patients with Stage 2 and 3 AKI who also have respiratory failure. The primary endpoint for the trial is days alive not on a ventilator and not on dialysis. Data from the KOURAGE trial are expected around the end of 2025, with this publication providing a strong scientific foundation for its anticipated results.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.