CalciMedica Announces Publication in the American Journal of Nephrology Discussing Design and Rationale of Phase 2 KOURAGE Trial of Auxora™ in AKI with Respiratory Failure
CalciMedica (NASDAQ:CALC) announced the publication of a manuscript in the American Journal of Nephrology detailing the design and rationale of their Phase 2 KOURAGE trial for Auxora™ in acute kidney injury (AKI) with respiratory failure. The publication includes promising preclinical data and a post-hoc analysis from the CARDEA trial.
Key findings include: 62.7% relative reduction and 29.3% absolute reduction in mortality for Auxora versus placebo in AKI patients from the CARDEA trial. The drug showed significant benefits in preclinical models, increasing glomerular filtration rate and preventing mortality. The research addresses a critical medical need, as approximately 3.7 million patients are hospitalized with AKI annually in the U.S., with a 50% mortality rate for severe cases with respiratory failure.
CalciMedica (NASDAQ:CALC) ha annunciato la pubblicazione di un manoscritto sull'American Journal of Nephrology che illustra il design e la motivazione dello studio di Fase 2 KOURAGE per Auxora™ nell'insufficienza renale acuta (AKI) con insufficienza respiratoria. La pubblicazione include dati preclinici promettenti e un'analisi post-hoc dello studio CARDEA.
I risultati principali mostrano una riduzione relativa del 62,7% e una riduzione assoluta del 29,3% della mortalità per Auxora rispetto al placebo nei pazienti con AKI dello studio CARDEA. Il farmaco ha dimostrato benefici significativi nei modelli preclinici, aumentando il tasso di filtrazione glomerulare e prevenendo la mortalità. La ricerca risponde a un bisogno medico critico, dato che circa 3,7 milioni di pazienti vengono ricoverati ogni anno negli Stati Uniti con AKI, con un tasso di mortalità del 50% nei casi gravi con insufficienza respiratoria.
CalciMedica (NASDAQ:CALC) anunció la publicación de un manuscrito en el American Journal of Nephrology que detalla el diseño y la justificación del ensayo de Fase 2 KOURAGE para Auxora™ en lesión renal aguda (AKI) con insuficiencia respiratoria. La publicación incluye datos preclínicos prometedores y un análisis post-hoc del ensayo CARDEA.
Los hallazgos clave incluyen una reducción relativa del 62,7% y una reducción absoluta del 29,3% en la mortalidad para Auxora frente a placebo en pacientes con AKI del ensayo CARDEA. El fármaco mostró beneficios significativos en modelos preclínicos, aumentando la tasa de filtración glomerular y previniendo la mortalidad. La investigación aborda una necesidad médica crítica, ya que aproximadamente 3,7 millones de pacientes son hospitalizados anualmente en EE. UU. con AKI, con una tasa de mortalidad del 50% en casos graves con insuficiencia respiratoria.
CalciMedica (NASDAQ:CALC)는 급성 신손상(AKI)과 호흡부전 환자를 대상으로 한 Auxora™의 2상 KOURAGE 임상시험 설계와 근거를 상세히 설명한 논문을 American Journal of Nephrology에 발표했다고 밝혔다. 이 출판물에는 유망한 전임상 데이터와 CARDEA 임상시험의 사후 분석이 포함되어 있다.
주요 결과로는 CARDEA 시험에서 AKI 환자에 대해 Auxora가 위약 대비 사망률을 62.7% 상대적 감소 및 29.3% 절대적 감소시켰다는 점이 있다. 이 약물은 전임상 모델에서 사구체 여과율을 증가시키고 사망을 예방하는 등 유의한 효과를 보였다. 연구는 미국에서 매년 약 370만 명의 환자가 AKI로 입원하며, 중증 호흡부전 환자의 사망률이 50%에 달하는 심각한 의료적 필요를 다루고 있다.
CalciMedica (NASDAQ:CALC) a annoncé la publication d'un manuscrit dans l'American Journal of Nephrology détaillant la conception et la justification de leur essai de phase 2 KOURAGE pour Auxora™ dans l'insuffisance rénale aiguë (IRA) avec insuffisance respiratoire. La publication comprend des données précliniques prometteuses ainsi qu'une analyse post-hoc de l'essai CARDEA.
Les résultats clés montrent une réduction relative de 62,7% et une réduction absolue de 29,3% de la mortalité pour Auxora par rapport au placebo chez les patients atteints d'IRA dans l'essai CARDEA. Le médicament a démontré des bénéfices significatifs dans des modèles précliniques, augmentant le taux de filtration glomérulaire et prévenant la mortalité. Cette recherche répond à un besoin médical crucial, environ 3,7 millions de patients étant hospitalisés chaque année aux États-Unis pour une IRA, avec un taux de mortalité de 50% pour les cas graves avec insuffisance respiratoire.
CalciMedica (NASDAQ:CALC) gab die Veröffentlichung eines Manuskripts im American Journal of Nephrology bekannt, das das Design und die Begründung der Phase-2-KOURAGE-Studie für Auxora™ bei akutem Nierenversagen (AKI) mit Atemversagen beschreibt. Die Veröffentlichung enthält vielversprechende präklinische Daten und eine Post-hoc-Analyse der CARDEA-Studie.
Wesentliche Ergebnisse sind eine relative Reduktion der Sterblichkeit um 62,7% und eine absolute Reduktion um 29,3% bei Auxora im Vergleich zu Placebo bei AKI-Patienten aus der CARDEA-Studie. Das Medikament zeigte in präklinischen Modellen signifikante Vorteile, indem es die glomeruläre Filtrationsrate erhöhte und die Sterblichkeit verhinderte. Die Forschung adressiert einen kritischen medizinischen Bedarf, da jährlich etwa 3,7 Millionen Patienten in den USA mit AKI hospitalisiert werden, mit einer Sterblichkeitsrate von 50% bei schweren Fällen mit Atemversagen.
- Post-hoc analysis showed 62.7% relative reduction in mortality for Auxora vs placebo in AKI patients
- Preclinical models demonstrated significant increase in glomerular filtration rate
- Publication in prestigious American Journal of Nephrology validates research approach
- Addresses large market with 3.7 million AKI patients hospitalized annually in U.S.
- Still in early Phase 2 clinical trial stage
- Current data based on small subgroup of only 38 patients
- Results derived from post-hoc analysis rather than primary trial endpoints
Insights
Publication showcases promising mortality reduction data for Auxora in AKI with respiratory failure, supporting ongoing Phase 2 trial.
The American Journal of Nephrology publication of CalciMedica's KOURAGE trial design represents an important scientific validation step for their CRAC channel inhibition approach in acute kidney injury (AKI) with respiratory failure. The preclinical data demonstrating Auxora's ability to increase glomerular filtration rate and prevent mortality in animal models provides mechanistic support for the drug's potential efficacy.
Most compelling is the post-hoc analysis from the CARDEA COVID-19 trial, showing a
The KOURAGE trial's primary endpoint – days alive not on ventilator and not on dialysis – directly addresses the most critical clinical outcomes for these patients. With an estimated 3.7 million AKI hospitalizations annually in the US, this represents a significant unmet medical need.
While these preliminary signals are encouraging, it's important to note the limitations of post-hoc analyses and the small subgroup sample size (n=38). The involvement of prominent nephrologists like Dr. Chertow on the steering committee adds credibility to the trial design, potentially increasing the likelihood of generating definitive evidence of Auxora's efficacy in this life-threatening condition.
Publication includes previously announced preclinical data of Auxora™ in acute kidney injury (AKI) models as well as a post-hoc analysis of patients in the Phase 2 CARDEA trial of Auxora in severe COVID-19 pneumonia who had AKI with respiratory failure at enrollment
The manuscript, entitled, "Inhibition of Calcium Release-Activated Calcium (CRAC) Channels to Treat Acute Kidney Injury: Design and Rationale of the KOURAGE Study," was co-authored by Lakhmir Chawla, M.D., Clinical Professor of Medicine at University of California San Diego, Chief Medical Officer at ExThera Medical, and Chair of the KOURAGE Steering Committee; Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica; Glenn Chertow, M.D., Norman S. Coplon/ Satellite Healthcare Professor of Medicine, Professor of Epidemiology and Population Health and Health Policy at Stanford Medicine, and Member of the KOURAGE Steering Committee; and other CalciMedica collaborators.
"Approximately 3.7 million patients are hospitalized with AKI in the
The manuscript describes the preclinical and clinical evidence supporting Auxora as a development candidate in AKI with respiratory failure, as well as the rationale for the patient selection and endpoint selection for CalciMedica's KOURAGE trial. In ischemia/reperfusion (I/R) models of AKI in rats, Auxora was found to significantly increase glomerular filtration rate (GFR) and to prevent mortality in Auxora-treated animals versus placebo-treated controls. In the CARDEA trial of patients with severe and critical COVID pneumonia, a post-hoc analysis of a subgroup of 38 patients with AKI at the time of enrollment showed a
About KOURAGE
KOURAGE is a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of Auxora in patients with severe acute kidney injury (AKI) with respiratory failure. The study is expected to enroll approximately 150 patients with Stage 2 and 3 AKI who have respiratory failure, and patients are randomized to receive 5 daily doses of Auxora or placebo. The study will assess patients up to day 30 following the final dosing to evaluate the number of days alive without the need for a ventilator or dialysis. The study's secondary endpoints include a composite measure of all-cause mortality, decline in estimated glomerular filtration rate (eGFR) and the occurrence of dialysis over a 90-day period, also known as MAKE-90 (Major Adverse Kidney Events at 90 days). Data from KOURAGE are expected around the end of 2025.
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, with data expected around the end of 2025. 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 planned and ongoing clinical trials and the timing, design, expected patient enrollment thereof and the expected timing for updates and the release of data from its Phase 2 KOURAGE trial of Auxora in AKI with associated respiratory failure around the end of 2025; the number of the treatable patients with AKI; the potential benefits of Auxora for the treatment of AKI and AP; 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 March 31, 2025, filed with the Securities and Exchange Commission (SEC) on May 14, 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
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calcimedica@argotpartners.com
(212) 600-1902
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