CalciMedica Shares Promising AKI Data on Auxora at International Conference

CalciMedica Unveils Promising AKI Data from CARDEA Trial at 30th International Conference

CalciMedica Inc., a clinical-stage biopharmaceutical company, recently made headlines by presenting pivotal findings from the Phase 2 CARDEA trial of Auxora™ during the 30th International Acute Kidney Injury (AKI) & Continuous Renal Replacement Therapy (CRRT) Conference held in San Diego, California. The company’s Chief Medical Officer, Dr. Sudarshan Hebbar, delivered an impactful plenary presentation, emphasizing the hereditary potential of CRAC channel inhibition in treating acute kidney injuries, particularly in patients suffering from severe COVID-19 pneumonia.

A Closer Look at Auxora and the CARDEA Trial

Auxora is CalciMedica's leading product candidate, designed to inhibit calcium release-activated calcium (CRAC) channels, which play a significant role in the pathophysiology of AKI. The Phase 2 CARDEA trial investigated the impact of Auxora in patients diagnosed with severe COVID-19 pneumonia alongside AKI—defined as an estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m² with moderate or severe respiratory distress.

In a post-hoc analysis focusing specifically on the subset of 38 AKI patients, extraordinary results were unveiled: a relative reduction of 62.7% in mortality at the 30-day mark when compared to a placebo group, with this survival benefit persisting through day 60. In stark contrast, the mortality rates stood at 46.7% for those on placebo versus just 17.4% for the Auxora group, showcasing an absolute mortality reduction of 29.3%.

Broader Implications Beyond the Study

The data from this subgroup of AKI patients highlights the efficacy of Auxora, which appears to provide significant therapeutic advantages not only for the broader patient population of the CARDEA trial, but specifically for individuals wrestling with both kidney and respiratory failures. The entire study cohort, consisting of 261 participants, showed a promising 56.3% relative mortality reduction at 30 days, reinforcing Auxora’s potential as a vital treatment option.

During his presentation, Dr. Hebbar reinforced the importance of CRAC channel inhibition as a potent therapeutic approach to AKI. He elaborated on several key preclinical and clinical findings:

- Immunomodulatory Effects: In animal models of AKI following ischemic reperfusion injury, the use of a CRAC inhibitor resulted in reduced Th17 cell populations in kidneys, suggesting a potential for immunomodulation.
- Tissue Protection: In vitro experiments demonstrated that inhibiting CRAC channels improved viability in kidney podocyte cells damaged by high levels of glucose or angiotensin II, shedding light on the protective capabilities of Auxora.
- Enhanced Recovery Metrics: In preclinical outcomes, subjects receiving Auxora exhibited quicker recovery of glomerular filtration rates (GFRs) and reduced mortality rates.
- Biomarker Changes: Patients in CARDEA showed favorable shifts in cardiorenal biomarkers, linked to the prevention of endothelial damage, correlating with improved clinical outcomes.

Future Directions and Ongoing Research

As CalciMedica moves forward, they are currently enrolling patients in a Phase 2 study named KOURAGE, aimed at further evaluating Auxora’s safety and effectiveness in patients with acute kidney injury and associated respiratory distress. Results from this ongoing clinical trial are expected in 2025, continuing Sols’ commitment to address urgent medical needs in critical settings.

In conclusion, the promising data emerging from the CARDEA trial underscores the pivotal role that Auxora may play in the treatment of AKI patients suffering from severe COVID-19 pneumonia. With ongoing trials and further analysis, CalciMedica aims to solidify Auxora's place in therapeutic regimens designed to combat life-threatening conditions where traditional solutions are sorely lacking. For further details on the presentation, visit CalciMedica's IR website.

About CalciMedica

Founded by scientific leaders with roots in prestigious research institutions, CalciMedica is on the forefront of developing innovative CRAC channel inhibition therapies intended to combat severe inflammatory and immunologic diseases. Given the urgent need for effective treatments, especially in critical care settings, the company’s ongoing research efforts are more crucial than ever before.