预约演示
更新于：2026-07-06
Zegocractin
更新于：2026-07-06
概要
基本信息
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
分子式C19H11ClF3N3O3 |
InChIKeyQQMKTHUGOQDEIL-UHFFFAOYSA-N |
CAS号1713240-67-5 |
关联
9
项与 Zegocractin 相关的临床试验NCT06374797
Auxora for the Treatment of AKI and Modulation of Injurious "Crosstalk" With the Lung: A Randomized Control Trial (KOURAGE)
Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be randomly assigned to either Auxora or matching placebo. Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions.
开始日期2024-07-01 |
申办/合作机构 |
CTRI/2023/05/053175
A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of Auxora in Patients with Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (CARPO)
开始日期2023-06-02 |
申办/合作机构 |
NCT05171920
A Placebo-Controlled Study of Auxora for the Extended Treatment of High- Risk Patients With Critical COVID-19 Pneumonia (CARDEA-Plus)
Up to 240 patients with confirmed COVID-19 pneumonia with a baseline imputed PaO2/FiO2 ≤200 receiving oxygen therapy via a high flow nasal cannula (HFNC) or non-invasive ventilation (NIV) will be enrolled at up to 40 sites. All patients will receive three doses of Auxora. Patients who continue to have severe hypoxemic respiratory failure at 48 hours will be randomized to receive three additional doses of Auxora or three doses of placebo. All patients will be followed for 60 days after enrollment into the study.
开始日期2022-01-24 |
申办/合作机构 |
100 项与 Zegocractin 相关的临床结果
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100 项与 Zegocractin 相关的转化医学
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100 项与 Zegocractin 相关的专利（医药）
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22
项与 Zegocractin 相关的文献（医药）2026-06-01·ARTERIOSCLEROSIS THROMBOSIS AND VASCULAR BIOLOGY
Orai1 Facilitates Angiogenesis After Myocardial Infarction Through Notch1 Signaling Pathway
Article
作者: Dominguez-Liste, Beltzane ; Rosado, Juan Antonio ; Siegfried, Geraldine ; Asprón, Carlos ; Smani, Tarik ; Escacena-Izquierdo, Loreto ; Galeano-Otero, Isabel ; Khatib, Abdel-Majid ; Rojas-Torres, Marta ; Durán-Ruiz, Mª Carmen ; Fernández-Chacón, Macarena ; Del Toro, Raquel ; Ordóñez-Fernández, Antonio
BACKGROUND::
Post-ischemic neovascularization is crucial for cardiac repair after myocardial infarction (MI). While Orai1-dependent store-operated calcium entry is known to support angiogenesis, its specific role after MI remains unclear.
METHODS::
We stimulated human umbilical vein endothelial cells (ECs) with serum from patients with ST-segment–elevation MI to analyze proangiogenic mechanisms and to mimic the post-infarct systemic environment. We performed integrative analysis, including transcriptomics, proteomics, post-MI mouse heart single-cell RNA sequencing, and immunostaining.
RESULTS::
ST-segment–elevation MI serum enhanced angiogenesis by upregulating VEGF (vascular endothelial growth factor), Notch, and Ca
2+
signaling pathways in EC. Notably, it increased Orai1 expression and store-operated calcium entry activity, required for EC migration and proliferation. Consistently, Orai1 inhibition with CM4620 significantly impaired subintestinal venous plexus development in zebrafish embryos. Single-cell RNA sequencing confirmed Orai1 upregulation, particularly in tip cells and proliferating EC clusters, which was confirmed in peri-infarct regions of mouse hearts and in tip-like cells in a 3-dimensional culture model. Proteomics analysis revealed that Orai1 silencing dysregulated VEGF and Notch1-related proangiogenic proteins. Furthermore, IL (interleukin)-17A mimicked ST-segment–elevation MI serum, inducing Orai1-mediated store-operated calcium entry and EC migration.
CONCLUSIONS::
Together, these findings reveal a novel role for the Orai1-dependent mechanism in post-MI angiogenesis, highlighting Orai1 as a potential therapeutic target for cardiac repair.
2026-04-01·HUMAN IMMUNOLOGY
Single-cell transcriptomics reveals targeted modulation of inflammatory repertoire by SOCE blockers
Article
作者: De Vlaminck, Iwijn ; Lagman, Mila ; Muthukumar, Thangamani ; Machaca, Khaled ; Suthanthiran, Manikkam ; Mantri, Madhav ; Pan, Chendong ; Stephanou, Andreas ; Shankaranarayanan, Divya ; Sun, Yanjie ; Xiang, Jenny ; Li, Carol
Store-operated calcium entry (SOCE) plays a critical role in regulating intracellular calcium signaling and is essential for immune cell functions. SOCE blockade with the pyrazole derivative BTP2 has been explored as an anti-inflammatory strategy in preclinical models, and Zegocractin (CM4620) is under clinical investigation as a CRAC channel inhibitor with activity in multiple tissues, including immune cells. However, the cell type-specific consequences of SOCE blockade under defined activation contexts remain incompletely understood. Here, we used multiplexed single-cell RNA sequencing to investigate the effects of two prototypic SOCE blockers, BTP2 and CM4620, on polyclonally stimulated, normal human peripheral blood mononuclear cells (PBMCs) in a phytohemagglutinin (PHA)-driven T-cell activation model. The data revealed that SOCE blockade suppressed cytotoxicity-associated transcriptional programs in CD8+ effector T cells and natural killer (NK) cells, restoring them to levels comparable to unstimulated cells. At the same time, SOCE blockade allowed CD4+ regulatory T cells to retain transcriptional signatures associated with immune regulation. These results indicate that, in this experimental model, SOCE blockade dampens cytotoxic programs while maintaining tolerance signatures, suggesting a potential avenue for targeted immune modulation in transplantation and other immune-mediated conditions. SIGNIFICANCE STATEMENT: Store-operated calcium entry (SOCE) is essential for immune activation, but broad immunosuppression can cause significant side effects. Using single-cell transcriptomics in a phytohemagglutinin (PHA)-driven T-cell activation model, we show that SOCE blockade with BTP2 or CM4620 suppresses pro-inflammatory and cytotoxic programs in CD8+ effector T cells and NK cells while preserving tolerance-associated pathways in CD4+ regulatory T cells. These findings suggest that SOCE blockade may provide a more targeted form of immune modulation, warranting future head-to-head comparisons with conventional immunosuppressants. Our results highlight the potential of SOCE blockers to reduce immune-mediated damage while maintaining tolerance, motivating further functional and translational studies in transplantation and other immune-mediated conditions.
2026-03-01·EClinicalMedicine
Zegocractin for acute pancreatitis with systemic inflammatory response syndrome: a randomized, controlled, dose-ranging, phase 2b trial
Article
作者: Wu, Bechien U ; Garg, Pramod K ; Buxbaum, James L ; Miller, Joseph ; Sutton, Robert ; Zhang, Jeffrey ; Stauderman, Kenneth ; Gardner, Timothy B ; Philip, Mathew ; Kumar, S Suresh ; Peacock, W Frank ; Hebbar, Sudarshan
Background:
Acute pancreatitis (AP) is without specific drug therapy. We conducted a phase 2b trial of the calcium release-activated calcium channel inhibitor zegocractin, previously found to accelerate recovery of food intake in AP, to determine dose-response, target population, endpoints, safety and tolerability in AP with systemic inflammatory response syndrome.
Methods:
This double-blind, randomised, placebo-controlled, phase 2b trial enrolled adults (aged ≥18 years) with AP and systemic inflammatory response syndrome at 37 centres in the US and India. Patients were randomly assigned (1:1:1:1) to receive placebo or 0.5 (low), 1.0 (medium) or 2.0 (high) mg per kilogramme intravenous zegocractin once daily for 3 days. The primary outcome was time to solid food tolerance, and all outcomes were specified a priori. This trial is registered with ClinicalTrials.gov (NCT04681066) and is complete.
Findings:
Between 30th March, 2021 and 16th April, 2024, 216 patients were assigned to placebo (N = 53), low (N = 53), medium (N = 56) or high (N = 54) dose zegocractin. The primary outcome of median time to solid food tolerance was 66, 78, 64, and 67 h in these groups respectively (n.s.). Dose-response was observed in patients with a high haematocrit (n = 92), the median times being 113.5, 78, 64 and 67 h, and in those with Balthazar D or E computed tomography at presentation (n = 145), at 112, 68.5, 68.5, and 66 h respectively. Overall, there were dose-dependent responses for the secondary outcomes new-onset severe respiratory failure (4, 4, 0, and 0 patients), new-onset necrotising pancreatitis (17, 17, 20 and 11 patients) and time to medically indicated discharge (104, 109.5, 104.5 and 89 median hours), reflected in an exploratory win ratio for high dose zegocractin compared to placebo of 1.640 (95% CI 1.030-2.612; p = 0.04).
Interpretation:
This trial was negative for the primary endpoint of time to solid food tolerance in the whole trial population but improvement with zegocractin was seen in patients with a high haematocrit or Balthazar score. Multiple secondary endpoints improved consistently with zegocractin compared to placebo, most notably in preventing new-onset severe respiratory failure. These findings identified a suitable dose, a potential patient population, and endpoints for a phase 3 trial.
Funding:
CalciMedica.
73
项与 Zegocractin 相关的新闻（医药）2026-06-27
Proceeds expected to support a focused pulmonary hypertension strategy, including a Phase 1b proof-of-concept study evaluating Auxora™ in PAH, with data anticipated mid-2027, and advancement of oral CRAC channel inhibitor CM5480 to IND clearance expected mid-2027
Anticipated cash runway into 2H 2027 with upfront proceeds
June 24, 2026 -- CalciMedica, Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for serious inflammatory, immunologic, and cardiopulmonary diseases, today announced it has entered into a definitive securities purchase agreement with leading healthcare investors for a private placement for up to approximately $49 million in gross proceeds.
The financing includes participation from new and existing investors, including members of CalciMedica's Board of Directors and management team. In the private placement, the Company will sell an aggregate of 18,673,429 units, with each unit comprised of (i) one share of its common stock or one pre-funded warrant to purchase shares of common stock at an exercise price of $0.0001 per share, (ii) a right to receive one Series A warrant to purchase shares of its common stock or pre-funded warrants to purchase shares of its common stock at an exercise price of $0.8033 per share, and (iii) a right to receive one Series B warrant to purchase shares of its common stock or pre-funded warrants to purchase shares of its common stock at an exercise price of $1.00 per share. The private placement is comprised of (i) upfront gross proceeds of approximately $15 million, representing a purchase price of $0.8033 for each unit or $0.8032 for each unit including a pre-funded warrant sold in lieu of common stock, (ii) Series A warrants with the potential for up to an additional $15 million in gross proceeds if exercised in full, and (iii) Series B warrants with the potential for up to approximately an additional $19 million in gross proceeds if exercised in full. Both Series A warrants and Series B warrants are issuable subject to stockholder approval in accordance with Nasdaq listing rules. The purchase price for each unit for the members of CalciMedica's Board of Directors and management team will be priced at or above the Nasdaq Consolidated Closing Bid Price as of June 23, 2026.
CalciMedica intends to use the proceeds to advance a focused pulmonary hypertension (PH) strategy built on its CRAC channel inhibition platform. The Company plans to conduct a capital-efficient Phase 1b proof-of-concept study evaluating Auxora™, its intravenous CRAC channel inhibitor, in patients with pulmonary arterial hypertension (PAH), with data anticipated mid-2027. This study is intended to generate early human evidence for CRAC channel inhibition in PH and de-risk the development of CM5480, the Company's proprietary oral CRAC channel inhibitor candidate for chronic treatment, for which IND clearance is anticipated in mid-2027. Proceeds are also expected to support continued IND-enabling activities for CM5480 and general corporate purposes.
"This financing reflects strong validation from leading biotech investors of our strategy to develop a differentiated, mechanistically novel therapy for patients with pulmonary hypertension, where PAH represents an established multi-billion-dollar market and significant unmet need remains across the broader pulmonary hypertension spectrum," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "Right ventricular failure is the principal driver of morbidity and mortality across PH, yet approved therapies act primarily on the pulmonary vasculature. CRAC channel inhibition has shown activity in both the pulmonary vasculature and the heart in preclinical models, and we believe it has the potential to be the first therapy to provide direct right ventricular support and anti-remodeling activity. With this capital, we expect to generate human proof-of-concept data with Auxora while advancing our oral candidate, CM5480, into the clinic."
PH includes a diverse group of diseases, but progressive right ventricular dysfunction is a shared consequence and a key determinant of survival across disease groups. Orai1, the pore-forming subunit of the CRAC channel, is upregulated in diseased pulmonary vasculature and cardiac tissue, where persistent CRAC channel signaling has been linked to proliferation, inflammation, vasoconstriction, fibrosis, and remodeling. In preclinical PH models, CM5480 and other CRAC channel inhibitors have been observed to reduce pulmonary vascular resistance, improve cardiac output, reduce right ventricular hypertrophy and fibrosis, and improve left ventricular function. In a rodent pulmonary artery banding model, which isolates cardiac effects from pulmonary vascular effects, CRAC channel inhibition with CM5480 also demonstrated evidence of direct protective activity in the right ventricle.
The planned Auxora Phase 1b study is designed to deliver an early, capital-efficient clinical signal on CRAC channel inhibition in PH. Auxora has been evaluated in more than 350 patients across completed and ongoing clinical trials. Following the Company's pause of enrollment in the Phase 2 KOURAGE trial of Auxora in acute kidney injury (AKI), comprehensive internal and external safety reviews identified no evidence of drug-related toxicity. CalciMedica subsequently submitted a protocol amendment and interim safety data to the FDA, and the agency completed its review without comments or questions, allowing clinical development of Auxora to proceed. The Company believes Auxora's established safety profile supports its continued development across the PH program and other indications.
"The preclinical animal model and genetic expression data supporting CRAC channel inhibition in pulmonary hypertension are compelling, particularly given the evidence of direct effects on cardiac function and right ventricular remodeling and failure," said Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica. "Auxora's safety database allows us to move directly into a focused proof-of-concept design in PAH with hemodynamic and imaging endpoints. A positive signal would both establish Auxora's potential in hospitalized PH settings and potentially de-risk our oral chronic-dosing program with CM5480."
Guggenheim Securities, LLC is acting as sole placement agent in connection with the private placement financing.
The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (Securities Act), or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws. Pursuant to the securities purchase agreement, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (SEC) registering the resale of the shares of common stock issued in the private placement and the shares of common stock issuable upon the exercise of the pre-funded warrants, the Series A warrants (including upon exercise of any pre-funded warrants issued upon exercise of the Series A warrants), and the Series B warrants (including upon exercise of any pre-funded warrants issued upon exercise of the Series B warrants) issued in the private placement no later than the 30th day after the closing of the private placement.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.
CM5480 is CalciMedica's proprietary, selective, oral CRAC channel inhibitor candidate in preclinical development for chronic inflammatory diseases, with the potential to be a first-in-class, differentiated therapy targeting pulmonary vascular and right ventricular remodeling — key drivers of disease progression in PH. Auxora™ (zegocractin) is CalciMedica's intravenous CRAC channel inhibitor, which has been evaluated in more than 350 patients across completed and ongoing clinical trials in acute pancreatitis, severe COVID-19 pneumonia, and acute kidney injury.
CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory, immunologic, and cardiopulmonary diseases. The Company's pipeline includes Auxora™ (zegocractin), its intravenous CRAC channel inhibitor, and CM5480, its proprietary, selective oral CRAC channel inhibitor candidate. Auxora has been evaluated in more than 350 patients across completed and ongoing clinical trials and is planned to be evaluated in a Phase 1b proof-of-concept study in patients with pulmonary arterial hypertension (PAH). CM5480 is being developed as a potential chronic oral therapy for chronic inflammatory diseases such as pulmonary hypertension (PH), with IND clearance expected in mid-2027. Together, the programs are intended to establish CRAC channel inhibition as a differentiated therapeutic approach targeting both pulmonary vascular remodeling and right ventricular dysfunction in PH.
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融资
2026-06-24
FDA reviewed a protocol amendment and interim safety data from the KOURAGE trial evaluating Auxora in AKI patients
No comments or questions were received
Confirms CalciMedica's ability to continue clinical development of Auxora across indications
LA JOLLA, Calif., June 24, 2026 /PRNewswire/ -- CalciMedica, Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for serious inflammatory, immunologic, and cardiopulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has reviewed a protocol amendment and interim safety data for CalciMedica's Phase 2 KOURAGE trial in patients with Stage 2 or Stage 3 acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF). Following the applicable review period, the Company has received no comments from the FDA on the submission, meaning that CalciMedica may continue to dose patients with Auxora™ in the study.
In January 2026, CalciMedica announced a pause in enrollment for the Phase 2 KOURAGE trial following a recommendation from the trial's Independent Data Monitoring Committee (IDMC) regarding a safety concern relating to a mortality imbalance that warranted reevaluation of the study design. The IDMC did not identify evidence of drug-related toxicity, and the Company's comprehensive review, performed in conjunction with external experts, reached the same conclusion while identifying imbalances in patients' baseline disease severity that necessitated revisions to the protocol design.
In March 2026, CalciMedica submitted an amendment to the KOURAGE trial to address design issues, which included refinements to patient inclusion criteria and changes to stratification methodology. The submission included a comprehensive safety assessment of the 107 patients who were dosed prior to the pause in enrollment, including cause-of-death information for all deaths and an analysis of serious adverse events (SAEs). Based on the Company's review, the observed SAEs were consistent with previous clinical experience with Auxora and did not appear to be drug related. The FDA has confirmed that the Clinical Pharmacology team of the Division of Cardiology and Nephrology has no comments regarding this submission. As the KOURAGE trial was never placed on clinical hold, and the decision to pause enrollment was made solely at the discretion of the Company, the FDA is not obligated to respond to the IND amendment. Following more than 60 days of review, the information contained in the amendment has resulted in no comments or questions from the FDA and no clinical hold communication.
CalciMedica expects feedback from the FDA on the design of a potential pivotal program evaluating Auxora in acute pancreatitis in the third quarter of 2026.
About CalciMedica
CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory, immunologic, and cardiopulmonary diseases. The Company's pipeline includes Auxora™ (zegocractin), its intravenous CRAC channel inhibitor, and CM5480, its proprietary, selective oral CRAC channel inhibitor candidate. Auxora has been evaluated in more than 350 patients across completed and ongoing clinical trials and is planned to be evaluated in a Phase 1b proof-of-concept study in patients with pulmonary arterial hypertension (PAH). CM5480 is being developed as a potential chronic oral therapy for chronic inflammatory diseases such as pulmonary hypertension (PH), with IND clearance expected in mid-2027. Together, the programs are intended to establish CRAC channel inhibition as a differentiated therapeutic approach targeting both pulmonary vascular remodeling and right ventricular dysfunction in PH. For more information, please visit .
Forward-Looking Statements
This communication contains forward-looking statements which include, but are not limited to, statements regarding CalciMedica's clinical development plans for Auxora™, including in acute kidney injury and acute pancreatitis; CalciMedica's ability to continue dosing patients with Auxora in the KOURAGE trial or otherwise continue clinical development of Auxora following FDA review of the KOURAGE protocol amendment and interim safety data; CalciMedica's interpretation of the FDA's lack of comments or questions regarding the submission; the potential resumption, continuation, design, conduct, timing, enrollment or completion of the KOURAGE trial or any future clinical trial evaluating Auxora in AKI; the potential safety, efficacy, clinical utility and regulatory development path for Auxora; CalciMedica's expectation to receive feedback from FDA regarding the design of a potential pivotal program evaluating Auxora in acute pancreatitis in the third quarter of 2026; CalciMedica's plans to advance CM5480 as a potential oral therapy for PH; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in inflammatory, immunologic and cardiopulmonary 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 and CM5480; 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 and CM5480; 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, 2026, filed with the SEC on May 12, 2026, 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 . 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
[email protected]
(212) 600-1902
SOURCE CalciMedica, Inc.
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临床2期临床1期
2026-05-12
FDA feedback on the Auxora™ pivotal program in acute pancreatitis and potential future development in acute kidney injury expected in 2Q 2026
Preclinical and IND-enabling studies advancing for CM5480, an oral CRAC channel inhibitor candidate, with IND submission in pulmonary hypertension expected in 2027
LA JOLLA, Calif., May 12, 2026 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for serious acute and chronic inflammatory, immunologic, and cardiopulmonary diseases, today reported financial results for the first quarter ended March 31, 2026 and provided clinical and corporate updates.
"We continue to work closely with the FDA as we finalize the design of our pivotal program for Auxora in AP and explore potential future development in AKI, both serious illnesses with high unmet need that are not adequately addressed by current standard of care," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "As we progress in these discussions and continue to advance our oral CRAC channel inhibitor, CM5480, in preclinical and IND-enabling studies for pulmonary hypertension, we are encouraged by preclinical data recently published in Human Immunology, which offers a strong endorsement of the mechanistic rationale for selective CRAC channel inhibition in inflammatory and immune-mediated diseases."
Recent Program Highlights:
Acute Pancreatitis (AP) Program Update
Continued positive FDA engagement on pivotal program in AP: CalciMedica continues to engage constructively with the U.S. Food and Drug Administration (FDA) regarding the design of a potential pivotal program evaluating Auxora in AP, with FDA feedback on program design expected in the second quarter of 2026. This would represent the first U.S. pivotal program evaluating a therapeutic candidate for AP, a serious inflammatory disease with approximately 300K hospitalizations annually in the U.S. alone.
Phase 2b CARPO trial results published in
eClinicalMedicine
: In February 2026, a manuscript authored by CalciMedica and collaborators titled "Zegocractin for acute pancreatitis with systemic inflammatory response syndrome: a randomized, controlled, dose-ranging, phase 2b trial" was published in eClinicalMedicine, a journal in The Lancet Discovery Science suite. The publication details previously announced topline results from 214 patients enrolled in the Phase 2b CARPO trial of Auxora in AP with systemic inflammatory response syndrome (SIRS). In hyper-inflamed patients, Auxora demonstrated clinically meaningful, dose-dependent reductions in median time to solid food tolerance. Across the overall study population, Auxora was well-tolerated and demonstrated dose-dependent improvements in multiple clinically relevant endpoints, including reductions in organ failure, necrotizing pancreatitis, and time to medically indicated discharge. Notably, medium- and high-dose Auxora arms achieved a statistically significant 100% reduction in new-onset severe respiratory failure compared to placebo (p < 0.05), and the high-dose Auxora arm achieved a statistically significant stratified win ratio of 1.640 (p < 0.05), which represents a hierarchical composite of mortality, new-onset severe respiratory failure, new-onset necrotizing pancreatitis, and time to medically indicated discharge.
Preclinical data published in
Human Immunolog
y: In April 2026, a manuscript authored by CalciMedica collaborators titled "Single-cell Transcriptomics Reveals Targeted Modulation of Inflammatory Repertoire by SOCE Blockers" was published in Human Immunology. The publication describes preclinical data showing that in normal human peripheral blood mononuclear cells (PBMCs) in a T-cell activation model, store-operated calcium entry (SOCE) blockers such as Auxora inhibit the expression of pro-inflammatory and cytotoxic genes within regulatory T cells, while crucially preserving tolerance-associated anti-inflammatory pathways. This selective modulation provides further mechanistic support for the continued evaluation of Auxora in acute and chronic inflammatory and immunologic illnesses such as AP and acute kidney injury. The data also suggest potential implications for targeted immune modulation in transplantation settings.
Acute Kidney Injury (AKI) with Acute Hypoxemic Respiratory Failure (AHRF) Program Update
FDA feedback expected regarding potential future development in AKI: Following comprehensive internal and external safety reviews after the Company paused enrollment in the Phase 2 KOURAGE trial of Auxora in patients with Stage 2 or Stage 3 AKI with associated AHRF, no evidence of drug-related toxicity was identified. The Company expects feedback from the FDA regarding potential future development of Auxora in AKI in the second quarter of 2026.
Pulmonary Hypertension (PH) Program Update
Preclinical activities to advance CM5480 in PH underway: Studies are ongoing to further characterize the pharmacology, pharmacokinetics, and safety profile of CM5480, CalciMedica's proprietary oral CRAC channel inhibitor candidate with the potential to be a first-in-class, differentiated therapy targeting pulmonary vascular and right ventricular remodeling, key drivers of disease progression in PH, including pulmonary arterial hypertension. An IND submission for CM5480 is anticipated in 2027.
Financial Results for the First Quarter Ended March 31, 2026:
Cash Position: Cash and cash equivalents were $8.2 million as of March 31, 2026. The Company expects its cash position to be sufficient to fund its current operating plan into the fourth quarter of 2026.
R&D Expenses: Research and development expenses were $3.5 million for the three months ended March 31, 2026, compared to $4.2 million for the three months ended March 31, 2025. The decrease of $0.7 million was primarily due to a decrease in preclinical and clinical trial related activities, and a decrease in chemistry, manufacturing and controls activities.
G&A Expenses: General and administrative expenses were $2.1 million for the three months ended March 31, 2026, compared to $2.3 million for the three months ended March 31, 2025. The decrease of $0.2 million was primarily due to a decrease in personnel costs.
Other Income: Other income was $10.6 million for the three months ended March 31, 2026, compared to $1.5 million for the three months ended March 31, 2025. The increase of $9.1 million was primarily due to the fair value adjustments to our promissory note and common stock warrants.
Net Income/Loss: Net income was $5.0 million, or $0.31 per basic share and $0.30 per diluted share, for the three months ended March 31, 2026, compared to a net loss of $5.0 million, or $0.36 per basic and diluted share, for the three months ended March 31, 2025.
About CalciMedica
CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory, immunologic, and cardiopulmonary 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 serious and life-threatening conditions with high unmet need. CalciMedica's lead product candidate Auxora™ has demonstrated positive clinical results in multiple completed efficacy clinical trials. The Company has reported data from a Phase 2b trial (CARPO; NCT04681066) evaluating Auxora in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS), as well as from a Phase 2 trial (CARDEA; NCT04345614) in patients with severe COVID-19 pneumonia. The Company initiated a Phase 2 trial (KOURAGE; NCT06374797) evaluating Auxora in patients with acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF); in January 2026, CalciMedica paused enrollment in the trial following a recommendation from the Independent Data Monitoring Committee and, as a next step, plans to discuss potential future development in AKI with the FDA. In addition, CalciMedica is advancing CM5480 as a potential oral therapy for pulmonary hypertension (PH), supported by preclinical data demonstrating effects on pulmonary vascular and right ventricular remodeling. For more information, please visit .
Forward-Looking Statements
This communication contains forward-looking statements which include, but are not limited to, CalciMedica's expected cash runway; CalciMedica's planned and ongoing clinical trials and the timing, design, and the expected timing for updates; statements regarding the anticipated timing of filing an IND; statements regarding the safety and efficacy of its product candidates; statements regarding FDA's constructive engagement on a pivotal program for Auxora in AP and expectations for FDA feedback on program design in the second quarter of 2026; statements regarding the potential of Auxora's clinical data to support a first U.S. pivotal program in AP; statements regarding the positive safety review of the unblinded KOURAGE dataset and discussions with the FDA in the second quarter of 2026 regarding the future development of Auxora in AKI; statements regarding expected cash runway; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in acute and chronic inflammatory and immunologic diseases such as AP, AKI and PH, including in transplantation settings. 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, 2026, being filed with the Securities and Exchange Commission (SEC) later today, 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 . 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
[email protected]
(212) 600-1902
SOURCE CalciMedica, Inc.
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 新型冠状病毒感染 | 临床3期 | 美国 | 2021-02-05 | |
| 急性肾损伤 | 临床2期 | 美国 | 2024-07-01 | |
| 胰腺炎 | 临床2期 | 美国 | 2018-03-12 | |
| 急性坏死性胰腺炎 | 临床2期 | 美国 | 2018-03-12 | |
| 全身炎症反应综合征 | 临床2期 | 美国 | 2018-03-12 | |
| 肺动脉高压 | 临床申请 | 美国 | 2026-07-01 | |
| 炎症 | 临床前 | 美国 | 2026-04-01 | |
| 成人呼吸窘迫综合征 | 临床前 | 美国 | 2021-09-07 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床2期 | 216 | 齋鏇襯艱夢遞構艱製衊(鹽獵獵蓋壓範鹽憲鏇襯) = 簾醖鑰繭窪鏇簾選鬱艱 醖廠膚顧膚壓艱遞窪蓋 (衊襯鹹衊鑰醖獵選淵憲 ) 更多 | 不佳 | 2026-03-01 | |||
齋鏇襯艱夢遞構艱製衊(鹽獵獵蓋壓範鹽憲鏇襯) = 製鬱膚遞選築觸鹹糧顧 醖廠膚顧膚壓艱遞窪蓋 (衊襯鹹衊鑰醖獵選淵憲 ) 更多 | |||||||
临床2期 | 10 | Placebo | 願築窪範範構鏇鑰遞觸(糧遞選鑰範顧憲壓廠醖) = 鑰齋遞醖範憲觸鹽鹽遞 鑰廠窪醖簾糧製鑰齋餘 (顧觸製憲齋顧願齋鏇範, 9.7) 更多 | - | 2025-11-21 | ||
临床2期 | 216 | Placebo | 願遞獵夢襯選蓋網鹹齋(製衊築襯構壓廠鑰觸鑰) = 餘鹽構選遞願壓遞醖淵 範襯鏇鏇襯齋憲醖製鹹 (製築艱獵築顧鬱構鏇壓, 蓋醖繭鹽糧憲鏇獵壓衊 ~ 廠鹽觸衊築鑰構獵壓鹽) 更多 | - | 2025-10-16 | ||
临床2期 | 38 | 醖選蓋顧壓膚鑰築廠觸(築膚製獵觸簾網顧觸願) = 窪築網築壓築觸襯鏇鏇 繭繭膚網襯醖膚醖壓廠 (鹹繭繭積願襯蓋艱窪膚 ) | 积极 | 2025-05-14 | |||
Placebo | 醖選蓋顧壓膚鑰築廠觸(築膚製獵觸簾網顧觸願) = 積簾齋廠遞襯選顧顧餘 繭繭膚網襯醖膚醖壓廠 (鹹繭繭積願襯蓋艱窪膚 ) | ||||||
临床2期 | 216 | 遞壓網鑰獵選糧淵淵鏇(壓艱齋鏇鏇獵簾鏇壓廠) = 餘選廠廠鹽範鏇顧廠廠 齋積艱鏇淵獵夢窪醖範 (構膚壓膚鹹淵憲遞鹽積 ) 达到 更多 | 积极 | 2024-07-27 | |||
遞壓網鑰獵選糧淵淵鏇(壓艱齋鏇鏇獵簾鏇壓廠) = 網簾廠簾觸繭獵遞築獵 齋積艱鏇淵獵夢窪醖範 (構膚壓膚鹹淵憲遞鹽積 ) 达到 更多 | |||||||
临床1/2期 | 9 | 鹽鬱齋鹹壓醖壓憲鹽艱(淵鹹簾艱齋衊艱齋鏇蓋) = 淵膚膚遞醖鏇夢鹽範鹽 襯願鹽鑰襯鏇簾齋繭鑰 (憲膚衊構膚選艱鑰襯餘 ) 更多 | 积极 | 2023-12-10 | |||
临床2期 | 7 | 廠夢衊鑰製蓋齋醖醖淵(糧獵壓膚簾鏇觸壓襯願) = 觸衊積壓觸構憲窪廠齋 艱網壓顧鏇齋築齋膚壓 (餘鹹繭襯襯鹽網獵積夢, 5.8) 更多 | - | 2022-05-03 | |||
临床2期 | 261 | 網蓋繭願餘製網艱顧鹽(鹽積壓膚窪鏇鏇鏇醖鹹) = 網遞顧構鏇製齋願窪獵 網蓋製選製鬱夢壓餘鏇 (遞遞淵製鏇選齋顧膚築 ) 更多 | 积极 | 2022-04-08 | |||
Placebo | 網蓋繭願餘製網艱顧鹽(鹽積壓膚窪鏇鏇鏇醖鹹) = 獵鹹鹽齋鬱築窪衊範蓋 網蓋製選製鬱夢壓餘鏇 (遞遞淵製鏇選齋顧膚築 ) 更多 | ||||||
临床2期 | 30 | 簾積膚膚簾鹹選遞衊遞(願餘衊齋獵壓衊遞願醖) = 衊糧蓋觸衊憲觸選齋衊 鹹衊淵淵鹹選襯夢夢簾 (選蓋糧鹽選範壓簾窪築 ) 更多 | 积极 | 2020-08-14 | |||
SOC | 簾積膚膚簾鹹選遞衊遞(願餘衊齋獵壓衊遞願醖) = 淵淵淵鬱選積構範鏇觸 鹹衊淵淵鹹選襯夢夢簾 (選蓋糧鹽選範壓簾窪築 ) 更多 |
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