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CalciMedica's Auxora™: A Potential Breakthrough for Acute Kidney Injury

CalciMedica Inc., a biopharmaceutical company dedicated to developing innovative therapies for inflammatory and immunological diseases, recently presented compelling data demonstrating the efficacy of their lead product, Auxora™, at the ASN Kidney Week 2025 conference. The findings, which emerged from a preclinical study involving an animal model of acute kidney injury (AKI), reveal significant improvements in kidney function and hint at Auxora's potential as a transformative treatment for patients suffering from severe AKI.

Overview of the Study

At the conference, CalciMedica showcased results from a study co-authored by leading researchers from Indiana University School of Medicine. The study aimed to evaluate the therapeutic effects of Auxora™ in a rat model of ischemia/reperfusion (I/R)-induced AKI. This model is typically used to simulate renal injury conditions that can result from various traumatic events in humans, thus providing a controlled environment to assess the drug's efficacy.

In the experiment, rats received either Auxora™ or a placebo at specified intervals following the induced kidney injury, with observations made at multiple time points. The primary focus was on measuring the glomerular filtration rate (GFR), a crucial indicator of kidney function, alongside immune cell infiltration in the kidneys and lungs.

Key Findings

The study delivered strong evidence supporting Auxora's role in mitigating inflammation and enhancing kidney function. Notable findings from the research included:

• - Significant Reductions in Inflammatory Cells: Treatment with Auxora™ resulted in a remarkable 64% reduction in Th-17 cells within the kidney and a 59% reduction in the lungs. Both reductions were statistically significant (p<0.05). Furthermore, IL-6 producing CD4 cells saw a substantial decrease of 69% in the lungs.
• - Improved Kidney Function: The rats treated with Auxora™ displayed a marked improvement in GFR 72 hours post-treatment, highlighting a significant recovery compared to the placebo group (p<0.01). Lower serum creatinine levels were also observed in the Auxora™ group.
• - Reduced Renal Injury: Histological assessments revealed that Auxora-treated animals experienced over 50% less tubular injury and pronounced necrosis in the kidneys than their placebo counterparts, indicating a protective effect against renal damage.

Implications for Clinical Practice

These compelling results emphasize the potential of Auxora™ as a treatment for patients with severe AKI, particularly those experiencing acute hypoxemic respiratory failure (AHRF). Elevated IL-17 levels in critically ill AKI patients are correlated with poor outcomes, including increased mortality. Therefore, the drug's ability to down-regulate this cytokine could alter the course of treatment for AKI and its associated complications, potentially reducing multi-organ failure risk.

Dr. Sudarshan Hebbar, Chief Medical Officer at CalciMedica, expressed enthusiasm about the study’s findings, stating, "The data presented at ASN Kidney Week further reinforce the mechanistic rationale for CRAC channel inhibition as a way to broadly modulate inflammatory and tissue-injury pathways in AKI and other critical illnesses."

As CalciMedica progresses towards the readout from its Phase 2 KOURAGE clinical trial, the increasing evidence supporting Auxora’s efficacy could pave the way for a new standard of care for patients facing the dire consequences of AKI.

About CalciMedica

CalciMedica is strategically focused on developing novel therapies through its proprietary CRAC channel inhibition technology to treat severe inflammatory and immunologic diseases. Auxora™, their flagship product, has demonstrated positive outcomes in previous clinical trials and is currently being evaluated in various conditions, including acute pancreatitis and COVID-19 pneumonia. With a commitment to addressing unmet medical needs, CalciMedica continues to spearhead innovation in therapeutic interventions for critical illnesses.

For more information on CalciMedica and their research initiatives, visit CalciMedica's website.