{"id":986302,"date":"2026-07-29T07:18:56","date_gmt":"2026-07-29T11:18:56","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/calcimedica-announces-fda-alignment-on-phase-2b-trial-design-for-auxora-in-acute-pancreatitis-and-identifies-diseases-first-potential-registrational-endpoints\/"},"modified":"2026-07-29T07:18:56","modified_gmt":"2026-07-29T11:18:56","slug":"calcimedica-announces-fda-alignment-on-phase-2b-trial-design-for-auxora-in-acute-pancreatitis-and-identifies-diseases-first-potential-registrational-endpoints","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/calcimedica-announces-fda-alignment-on-phase-2b-trial-design-for-auxora-in-acute-pancreatitis-and-identifies-diseases-first-potential-registrational-endpoints\/","title":{"rendered":"CalciMedica Announces FDA Alignment on Phase 2b Trial Design for Auxora in Acute Pancreatitis and Identifies Disease’s First Potential Registrational Endpoints"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n FDA aligned on new-onset severe respiratory failure as the Phase 2b primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints<\/i>\n <\/p>\n

\n FDA aligned on a strategy to evaluate elevated lactate dehydrogenase (LDH) as a potential enrichment marker for identifying patients at increased risk of new-onset severe respiratory failure
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\n LA JOLLA, Calif.<\/span>, July 29, 2026<\/span> \/PRNewswire\/ — CalciMedica, Inc. (“CalciMedica” or the “Company”) (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing calcium release-activated calcium (CRAC) channel inhibition therapies for serious inflammatory, immunologic, and cardiopulmonary diseases, today announced that, following a Type C Focused Meeting, \u00a0the U.S. Food and Drug Administration (FDA) and the Company have aligned on Phase 2b trial endpoints and a patient population enrichment strategy for its planned registration program evaluating Auxora\u2122 in acute pancreatitis (AP).<\/p>\n

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\n \"CalciMedica\n <\/p>\n<\/p><\/div>\n

Auxora is designed to inhibit CRAC channels, which regulate calcium entry into endothelial cells and drive the vascular injury and inflammation seen across acute inflammatory diseases.\u00b9,<\/sup>\u00b2 In AP, this endothelial injury is believed to contribute to new-onset severe respiratory failure, a major driver of mortality and morbidity in the disease and the endpoint on which FDA and CalciMedica aligned for the Phase 2b trial. In the completed CARPO trial in patients with AP, patients treated with medium and high doses of Auxora experienced a 100% reduction in new-onset severe respiratory failure.3<\/sup> These findings are consistent with Auxora’s observed clinical effects on respiratory compromised patients.<\/p>\n

“Acute pancreatitis is a serious disease with no approved therapies, and this alignment with FDA is an important step toward what would be the first U.S. pivotal program evaluating a therapeutic candidate for AP,” said Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica. “Alignment on a biomarker-based enrichment approach using LDH to potentially identify patients at greater risk of severe disease gives us a clear path to a Phase 2b trial designed to inform a well-powered Phase 3 program.”<\/p>\n

“There hasn’t been a validated and practical way to identify which patients with AP are most likely to progress to severe, life-threatening disease,” said Timothy B. Gardner, M.D., Director of Pancreatic Disorders at Dartmouth\u2013Hitchcock Medical Center and senior author of the American College of Gastroenterology’s acute pancreatitis clinical guidelines. “Respiratory failure is the primary driver of prolonged hospital stays and mortality in this disease, yet no therapy has been approved for AP, and the field has not established a clinical trial endpoint framework to evaluate treatments. CalciMedica’s program will help define that framework directly with FDA, and it reflects how AP actually presents in the clinic.”<\/p>\n

FDA aligned on new-onset severe respiratory failure as the Phase 2b trial’s primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints. FDA and CalciMedica also aligned on the Phase 2b trial’s role in confirming patient selection criteria and informing the endpoint for the Phase 3 program. The parties agreed to discuss additional Phase 3 program design features at future meetings. Based on its discussions with FDA, the Company believes that new-onset severe respiratory failure could be an important component of the Phase 3 registrational endpoint strategy.<\/p>\n

The Phase 2b trial will also prospectively assess whether elevated LDH, a recognized marker of tissue injury and disease severity and a component of the Ranson criteria for AP severity, identifies patients at greater risk of developing severe disease. This approach is supported by an exploratory analysis of the completed CARPO trial, in which elevated LDH was associated with a higher incidence of new-onset severe respiratory failure. The Company believes LDH may offer a rapid and readily available assessment of risk because, in CARPO, higher LDH was associated with higher levels of IL-6, a known correlate of severe outcomes in AP patients. Among the patients with both baseline LDH and IL-6 measurements, those with LDH above 240 U\/L (n=30) had a median IL-6 of 134\u00a0pg\/mL, compared with 49 pg\/mL among those with LDH below 240 U\/L (n=24) (p=0.004). CalciMedica plans to evaluate the relationship between LDH and events of new-onset severe respiratory failure in the Phase 2b trial to establish that LDH may be used as an enrichment criterion for the Phase 3 program.<\/p>\n

CalciMedica continues to advance preparations for the Phase 2b trial, including engaging with a contract research organization and holding discussions with potential clinical sites.<\/p>\n

\n About Acute Pancreatitis
<\/b>Acute pancreatitis is a serious inflammatory disease with no FDA-approved therapies and accounts for approximately 300,000 hospitalizations annually in the U.S.5<\/sup> Mortality in AP follows a bimodal pattern: early deaths are driven primarily by respiratory failure, while later deaths typically follow infected pancreatic necrosis that progresses to septic shock and, ultimately, respiratory failure. Respiratory failure is therefore both a leading cause of death in AP and a major driver of intensive care resource use, including prolonged mechanical ventilation and hospitalization.<\/p>\n

No therapy has been approved for AP in the United States, and no clinical trial endpoint framework for the disease has been established through a completed U.S. registration program. CalciMedica’s planned Phase 2b trial is designed to prospectively evaluate new-onset severe respiratory failure as a primary endpoint in AP, with multi-organ failure and time to medically indicated discharge as key secondary endpoints. This endpoint framework was developed in consultation with FDA in the absence of an established regulatory precedent for AP.<\/p>\n

\n About Auxora
<\/b>Auxora\u2122 (<\/span>zegocractin) is <\/span>CalciMedica’s proprietary intravenous <\/span>CRAC channel inhibitor and most advanced pipeline candidate. <\/span>Auxora is designed to act through a dual mechanism: in immune cells, it modulates the immune response by inhibiting <\/span>CRAC channel activation that drives <\/span>cytokine release and inflammation; in organ tissue cells, it limits excess calcium entry that can cause tissue injury and cell death. In a Phase 2 trial in COVID-19 pneumonia, <\/span>Auxora treatment was associated with reduced levels of <\/span>D-dimer and other biomarkers of endothelial activation, an effect that correlated with improved oxygenation and clinical status.<\/span>4<\/sup><\/p>\n

Auxora has been evaluated in multiple completed and ongoing clinical trials involving more than 350 patients across indications characterized by endothelial damage and respiratory failure:<\/p>\n