CalciMedica Presents AKI Data from a Post-Hoc Analysis of the Phase 2 CARDEA trial of Auxora™ in Severe COVID-19 Pneumonia at the 30th International AKI & CRRT Conference
CalciMedica (CALC) presented new data from a post-hoc analysis of their Phase 2 CARDEA trial studying Auxora™ in severe COVID-19 pneumonia patients with Acute Kidney Injury (AKI). The analysis revealed:
- A 62.7% relative reduction in mortality at day 30 (sustained through day 60) in AKI patients treated with Auxora versus placebo
- Only 17.4% (4/23) Auxora-treated patients died compared to 46.7% (7/15) on placebo
- An absolute mortality reduction of 29.3% in the AKI subset
The study included 38 patients with AKI (defined as eGFR ≤ 60 ml/min/1.73 m²) and moderate/severe respiratory failure. Preclinical studies showed CRAC channel inhibition reduced Th17 cells in rat kidneys, protected podocyte cells, and improved GFR recovery. The company is currently conducting a Phase 2 trial of Auxora in Stage 2/3 AKI patients with acute hypoxemic respiratory failure, with results expected in 2025.
CalciMedica (CALC) ha presentato nuovi dati da un'analisi post-hoc del loro trial di Fase 2 CARDEA che studia Auxora™ in pazienti con polmonite severa da COVID-19 e Lesione Renale Acuta (AKI). L'analisi ha rivelato:
- Una riduzione relativa della mortalità del 62,7% al giorno 30 (sostenuta fino al giorno 60) nei pazienti con AKI trattati con Auxora rispetto al placebo
- Solo il 17,4% (4/23) dei pazienti trattati con Auxora è deceduto rispetto al 46,7% (7/15) del gruppo placebo
- Una riduzione assoluta della mortalità del 29,3% nel sottogruppo AKI
Lo studio ha incluso 38 pazienti con AKI (definito come eGFR ≤ 60 ml/min/1,73 m²) e insufficienza respiratoria moderata/severa. Studi preclinici hanno mostrato che l'inibizione dei canali CRAC ha ridotto le cellule Th17 nei reni dei ratti, protetto le cellule podocitarie e migliorato il recupero della GFR. Attualmente, la società sta conducendo un trial di Fase 2 di Auxora in pazienti con AKI di Stadio 2/3 con insufficienza respiratoria ipossiemica acuta, con risultati attesi nel 2025.
CalciMedica (CALC) presentó nuevos datos de un análisis post-hoc de su ensayo de Fase 2 CARDEA que estudia Auxora™ en pacientes con neumonía severa por COVID-19 con Lesión Renal Aguda (AKI). El análisis reveló:
- Una reducción relativa de la mortalidad del 62,7% al día 30 (sostenida hasta el día 60) en pacientes con AKI tratados con Auxora en comparación con el placebo
- Solo el 17,4% (4/23) de los pacientes tratados con Auxora fallecieron en comparación con el 46,7% (7/15) en el grupo placebo
- Una reducción absoluta de la mortalidad del 29,3% en el subgrupo de AKI
El estudio incluyó a 38 pacientes con AKI (definido como eGFR ≤ 60 ml/min/1,73 m²) y falla respiratoria moderada/severa. Estudios preclínicos mostraron que la inhibición de los canales CRAC redujo las células Th17 en los riñones de ratas, protegió las células podocitarias y mejoró la recuperación de la GFR. Actualmente, la compañía está llevando a cabo un ensayo de Fase 2 de Auxora en pacientes con AKI en Etapa 2/3 con falla respiratoria hipoxémica aguda, con resultados esperados para 2025.
CalciMedica (CALC)는 급성 신장 손상(AKI)이 있는 중증 COVID-19 폐렴 환자에서 Auxora™에 대한 2상 CARDEA 시험의 후속 분석 결과를 발표했습니다. 분석 결과는 다음과 같습니다:
- Auxora로 치료받은 AKI 환자에서 30일째 사망률이 62.7% 감소했으며(60일째까지 지속됨)
- Auxora로 치료받은 환자 중 17.4% (4/23)가 사망한 반면, 위약 그룹에서는 46.7% (7/15)가 사망했습니다
- AKI 하위 그룹에서 절대 사망률 감소가 29.3% 나타났습니다
이 연구에는 AKI 환자 38명이 포함되었으며(AKI는 eGFR ≤ 60 ml/min/1.73 m²로 정의됨) 중등도/중증 호흡 부전이 있었습니다. 전임상 연구에서는 CRAC 채널 억제가 쥐의 신장에서 Th17 세포를 감소시키고, 포도세포를 보호하며, GFR 회복을 개선하는 것으로 나타났습니다. 이 회사는 현재 급성 저산소성 호흡 부전이 있는 2/3기 AKI 환자에 대한 Auxora의 2상 시험을 진행 중이며, 결과는 2025년에 발표될 예정입니다.
CalciMedica (CALC) a présenté de nouvelles données issues d'une analyse post-hoc de leur essai de Phase 2 CARDEA étudiant Auxora™ chez des patients atteints de pneumonie sévère due à la COVID-19 avec lésion rénale aiguë (AKI). L'analyse a révélé :
- Une réduction relative de la mortalité de 62,7% au jour 30 (maintenue jusqu'au jour 60) chez les patients AKI traités avec Auxora par rapport au placebo
- Seulement 17,4% (4/23) des patients traités avec Auxora sont décédés contre 46,7% (7/15) dans le groupe placebo
- Une réduction absolue de la mortalité de 29,3% dans le sous-groupe AKI
L'étude a inclus 38 patients atteints d'AKI (défini comme eGFR ≤ 60 ml/min/1,73 m²) et d'insuffisance respiratoire modérée/sévère. Des études précliniques ont montré que l'inhibition des canaux CRAC réduisait les cellules Th17 dans les reins de rats, protégeait les podocytes et améliorait la récupération de la GFR. La société mène actuellement un essai de Phase 2 d'Auxora chez des patients atteints d'AKI de stade 2/3 avec insuffisance respiratoire hypoxémique aiguë, dont les résultats sont attendus en 2025.
CalciMedica (CALC) hat neue Daten aus einer post-hoc Analyse ihrer Phase 2 CARDEA-Studie vorgestellt, die Auxora™ bei Patienten mit schwerer COVID-19-Pneumonie und akuter Nierenverletzung (AKI) untersucht. Die Analyse ergab:
- Eine relative Reduktion der Sterblichkeit von 62,7% am Tag 30 (bis Tag 60 aufrechterhalten) bei AKI-Patienten, die mit Auxora behandelt wurden, im Vergleich zu Placebo
- Nur 17,4% (4/23) der mit Auxora behandelten Patienten starben im Vergleich zu 46,7% (7/15) in der Placebo-Gruppe
- Eine absolute Reduktion der Sterblichkeit von 29,3% in der AKI-Untergruppe
Die Studie umfasste 38 Patienten mit AKI (definiert als eGFR ≤ 60 ml/min/1,73 m²) und moderater/schwerer Ateminsuffizienz. Vorklinische Studien zeigten, dass die Hemmung von CRAC-Kanälen Th17-Zellen in den Nieren von Ratten reduzierte, Podozyten schützte und die GFR-Wiederherstellung verbesserte. Das Unternehmen führt derzeit eine Phase-2-Studie zu Auxora bei Patienten mit AKI im Stadium 2/3 mit akuter hypoxämischer Ateminsuffizienz durch, deren Ergebnisse für 2025 erwartet werden.
- 62.7% relative reduction in mortality at day 30 and 60 in AKI patients
- 29.3% absolute reduction in mortality in AKI subset
- Positive preclinical data showing improved GFR recovery
- Ongoing Phase 2 trial with results expected in 2025
- Small AKI patient subset (only 38 patients)
- Results based on post-hoc analysis rather than primary endpoint
Insights
CalciMedica's post-hoc analysis from their Phase 2 CARDEA trial reveals striking efficacy in a critical patient subset. The
This data strengthens the scientific rationale for Auxora's mechanism of action in AKI through CRAC channel inhibition. The supporting preclinical and biomarker evidence demonstrates both immunomodulatory and tissue-protective effects, potentially addressing multiple pathways in kidney injury.
What's particularly valuable about this analysis is how it aligns with CalciMedica's ongoing Phase 2 KOURAGE study, which targets a similar patient population with kidney and respiratory failure. The substantial mortality benefit observed provides encouraging validation for their clinical development strategy.
While post-hoc analyses have inherent limitations, the magnitude of effect seen here warrants attention. The sample size is modest (38 patients), but the consistent mortality benefit, coupled with mechanistic rationale from multiple complementary studies, suggests Auxora may represent a meaningful advancement for a condition with few treatment options.
From a clinical perspective, this post-hoc analysis reveals intriguing therapeutic potential for Auxora. The
What strengthens this finding is the comprehensive mechanistic evidence supporting CRAC channel inhibition in AKI. The preclinical data showing decreased Th17 cells in injured kidneys highlights important immunomodulatory effects, while the protection of podocytes demonstrates direct cellular benefits. These dual mechanisms suggest Auxora could address both inflammatory and direct tissue injury pathways in AKI.
The biomarker data showing favorable changes in angiopoietin-1/2 and D-dimers provides valuable translational evidence connecting the preclinical observations to clinical outcomes. These biomarkers strongly correlate with endothelial protection, a critical factor in preserving kidney function during systemic illness.
Though this analysis comes from COVID-19 patients, the pathophysiological mechanisms of AKI extend beyond specific triggering conditions. The consistent benefit seen across preclinical models and this clinical subset analysis suggests potential applicability to broader AKI populations. The upcoming KOURAGE trial results will be important for confirming these promising signals in the specific population CalciMedica is targeting.
The new data presented were based on a post-hoc analysis from the previously completed Phase 2 CARDEA trial of Auxora in severe COVID-19 pneumonia. The study included 38 patients who enrolled with AKI, defined as an estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m², in addition to moderate or severe respiratory failure, which was an inclusion criterion. Within this subset:
- Patients treated with Auxora showed a
62.7% relative reduction versus placebo in mortality at day 30 which persisted through day 60.
- 7 out of 15 (
46.7% ) patients on placebo died by day 30 and day 60 as compared to 4 out of 23 (17.4% ) patients on Auxora. - Auxora exhibited an absolute reduction in mortality of
29.3% .
This reduction in mortality in the patient subset with AKI exceeded that of the entire study population. In the entire population (n = 261), a
In his presentation, Dr. Hebbar also summarized previously disclosed data supporting the role of CRAC channel inhibition as a potential therapeutic mechanism in AKI. Key data include:
- In preclinical biomarker studies, rats with AKI following ischemic reperfusion injury had decreased Th17 cells in their kidneys when receiving a CRAC inhibitor versus control, highlighting immunomodulatory effects.
- In in-vitro experiments, CRAC channel inhibition ameliorated injury to podocyte cells (kidney cells involved in filtration) caused by high glucose or angiotensin II, highlighting tissue-protective effects.
- In preclinical outcome studies, GFRs recovered more quickly and mortality was reduced in rats with severe or moderately severe AKI that received Auxora versus placebo.
- In clinical trial biomarker studies, CARDEA patients who received Auxora versus placebo had changes in cardiorenal biomarkers—increases in angiopoietin-1 and decreases in angiopoietin-2 and D-dimers—which have been linked to the prevention of endothelial damage in prior studies and were correlated with improved outcomes in CARDEA.
- At doses used experimentally and clinically, Auxora potentially provides a therapeutic window to treat acute critical illnesses without increasing risk of infection.
"As illustrated by these data, the biological rationale for CRAC channel inhibition as a potential therapeutic mechanism for AKI is compelling," said Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica. "The post-hoc analysis from CARDEA is especially relevant given that the
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. 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). The Company has also completed 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 acute hypoxemic respiratory failure (AHRF) with data expected in 2025 and continuing to support the ongoing Phase 1/2 trial (called CRSPA – NCT04195347) in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT) with data expected in 2025. CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, CA. For more information, please visit www.calcimedica.com.
Forward-Looking Statements
This communication contains forward-looking statements which include, but are not limited to, results of post-hoc analyses from the previously completed Phase 2 CARDEA trial of Auxora and CalciMedica's ongoing and planned clinical trials and the timing and design thereof, and the expected timing for the release of data from those trials, including its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT and its ongoing Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF; the potential benefits of Auxora for the treatment of AP, AKI and AIPT; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in life-threatening 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. 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 September 30, 2024, filed with the U.S. Securities and Exchange Commission (SEC) on November 13, 2024, 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
Argot Partners
Sarah Sutton/Kevin Murphy
calcimedica@argotpartners.com
(212) 600-1902
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FAQ
What were the mortality reduction rates for CALC's Auxora in AKI patients during the CARDEA trial?
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