CalciMedica Presents Data from Preclinical Study of Auxora™ in an Animal Model of AKI at ASN Kidney Week 2025
Rhea-AI Summary
CalciMedica (NASDAQ: CALC) presented preclinical data at ASN Kidney Week 2025 showing that three-day IV dosing of Auxora (16 mg/kg) in a rat ischemia/reperfusion AKI model reduced kidney Th‑17 cells by 64% versus placebo and lung Th‑17 cells by 59% (each p<0.05).
Auxora also decreased IL‑6–producing CD4 cells in lung by 69% (p<0.05), produced greater GFR recovery (p<0.01), lower serum creatinine (p<0.05) at 72 hours, and reduced tubular injury by >50% versus placebo. Findings support the mechanistic rationale for Auxora in severe AKI with acute hypoxemic respiratory failure and align with the ongoing Phase 2 KOURAGE trial targeting patients with elevated IL‑17.
Positive
- Kidney Th‑17 cells reduced by 64% versus placebo (p<0.05)
- Lung Th‑17 cells reduced by 59% versus placebo (p<0.05)
- IL‑6–producing CD4 lung cells reduced by 69% (p<0.05)
- Greater GFR recovery at 72 hours (p<0.01)
- Tubular injury reduced by >50% versus placebo
Negative
- None.
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Treatment with Auxora significantly reduced IL-17–related inflammation in both kidney and lung, significantly increased glomerular filtration rate (GFR), and decreased renal injury in a rat model of AKI
Findings reinforce the mechanistic rationale for Auxora as a potential treatment for severe AKI with respiratory failure, currently being evaluated in the Phase 2 KOURAGE trial
In the study, rat models of ischemia/reperfusion (I/R)-induced acute kidney injury (AKI) were treated with either Auxora™ (16 mg/kg, administered intravenously over 4 hours) or placebo at 6, 24, and 48 hours following I/R. GFR was reassessed at 72 hours to evaluate the effects of Auxora on renal function following an established loss of GFR. Flow cytometry was also performed at 72 hours to quantify immune cell subsets in the kidney and lung.
Key findings from the study include:
- Three-day dosing of Auxora significantly reduced the levels of Th-17 cells in the kidney by
64% versus placebo (p<0.05) consistent with previously reported50% reductions following a single dose of drug (p<0.05). - Three-day dosing of Auxora reduced Th-17 cells in the lung by
59% versus placebo and IL-6-producing CD4 cells by69% (each p<0.05). - Auxora significantly improved kidney function at 72 hours, with greater GFR recovery (p˂0.01) and lower serum creatinine (p<0.05) versus placebo.
- Auxora-treated animals experienced less prominent kidney necrosis and a greater than
50% reduction in tubular injury versus placebo, as determined by blinded histological assessment.
These new observations of reductions in IL-17 and IL-6 producing immune cells in animal lungs provide strong mechanistic support for Auxora as a potential treatment of severe AKI with acute hypoxemic respiratory failure (AHRF). Critically ill patients with severe AKI have markedly elevated IL-17 levels that correlate with mortality and major adverse kidney events. IL-17 is implicated in lung-kidney crosstalk that can drive multi-organ failure in patients, so down-regulation of this cytokine may be key to dampening this damaging disease pathway. The inclusion and exclusion criteria of CalciMedica's Phase 2 KOURAGE study in severe AKI patients with AHRF are expected to enrich for patients with elevated IL-17 levels.
"The data presented at ASN Kidney Week further reinforce the mechanistic rationale of CRAC channel inhibition as a way to broadly modulate inflammatory and tissue-injury pathways in AKI and other critical illnesses," said Sudarshan Hebbar, M.D., CMO of CalciMedica. "As we approach the readout from the Phase 2 KOURAGE trial of Auxora in AKI with AHRF, it is encouraging to see the growing body of evidence supporting Auxora's potential to be a transformative therapy for this critically ill population with profound unmet need."
The presentation is now available on the Medical Events & Presentations section of CalciMedica's IR website at https://ir.calcimedica.com/news-events/medical-events-publications.
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. For more information, please visit www.calcimedica.com.
Forward-Looking Statements
This communication contains forward-looking statements which include, but are not limited to CalciMedica's belief that treatment with Auxora reduces IL-17-related inflammation in kidney and lung, reduces IL-6-producing CD4 cells in the lung, and significantly improves kidney function which reinforces the mechanistic rationale for Auxora as a potential treatment for severe AKI with AHRF; 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; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in acute and chronic inflammatory and immunologic diseases. 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.
Contact Information
Kevin Murphy
calcimedica@argotpartners.com
(212) 600-1902
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SOURCE CalciMedica, Inc.
FAQ
What did CalciMedica announce about Auxora at ASN Kidney Week 2025?
How did Auxora affect kidney function in the rat AKI study (CalciMedica CALC)?
What dose and dosing schedule of Auxora was used in the November 10, 2025 preclinical poster?
Do the ASN Kidney Week data link Auxora to lung‑kidney inflammation relevant for AKI patients?
How do the preclinical findings relate to CalciMedica's Phase 2 KOURAGE trial (CALC)?
Where can investors view CalciMedica's ASN Kidney Week presentation for CALC?
