LA JOLLA, Calif., April 24, 2024 /PRNewswire/ -- CalciMedica Inc. ('CalciMedica') (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today announced that the last patient has been enrolled in its Phase 2b CARPO trial of Auxora™ in acute pancreatitis (AP).

加利福尼亚州拉霍亚，2024年4月24日/PRNewswire/--CalciMedica Inc.（“CalciMedica”）（纳斯达克：CALC），一家临床阶段的生物制药公司，专注于开发新型钙释放激活钙（CRAC）通道抑制疗法，用于急性和慢性炎症和免疫性疾病，今天宣布最后一名患者已参加Auxora™治疗急性胰腺炎（AP）的2b期CARPO试验。

Auxora is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels that is being developed for use in patients with acute inflammatory and immunologic illnesses..

Auxora是一种有效且选择性的含Orai1的CRAC通道小分子抑制剂，正在开发用于急性炎症和免疫疾病患者。。

'We are very grateful to the patients and families that have put their trust in us throughout this enrollment process,' said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. 'We are a significant step closer to delivering a potential treatment for acute pancreatitis, for which there is currently no approved therapy.

CalciMedica首席执行官雷切尔·莱赫尼（RachelLeheny）博士说：“我们非常感谢在整个注册过程中信任我们的患者和家属。”我们离为急性胰腺炎提供潜在治疗迈出了重要的一步，目前尚无批准的治疗方法。

We look forward to sharing the results of this clinical trial in the coming weeks once the last patient has finished treatment and the data have been analyzed.'.

一旦最后一名患者完成治疗并对数据进行了分析，我们期待着在未来几周分享这项临床试验的结果。”。

CARPO is an international, randomized, double-blind, placebo-controlled, dose-ranging trial intended to establish Auxora's dose-response and efficacy in AP with accompanying systemic inflammatory response syndrome (SIRS). The trial reached its target enrollment of 216. These patients have been randomized into four groups to receive either 2.0 mg/kg, 1.0 mg/kg or 0.5 mg/kg of Auxora or a dose of placebo intravenously every 24 hours for a total of three doses.

CARPO是一项国际性、随机、双盲、安慰剂对照、剂量范围试验，旨在确定Auxora在伴有全身炎症反应综合征（SIRS）的AP中的剂量反应和疗效。该试验达到了216人的目标入学人数。这些患者被随机分为四组，每24小时静脉注射2.0 mg/kg，1.0 mg/kg或0.5 mg/kg Auxora或一剂安慰剂，共三剂。

CARPO protocol requires that treatment and observation of patients continue for 30 days, and the company plans to report topline data later this quarter..

CARPO协议要求患者的治疗和观察持续30天，该公司计划在本季度晚些时候报告topline数据。。

About Auxora™

关于Auxora™

CalciMedica's lead clinical compound, Auxora™, is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels that is being developed for use in patients with acute inflammatory and immunologic illnesses. CRAC channels are found on many cell types, including immune system cells, endothelium cells and pancreatic acinar cells, where aberrant activation of these channels may play a key role in the pathobiology of acute and chronic inflammatory syndromes.

CalciMedica的主要临床化合物Auxora™是一种有效且选择性的含Orai1的CRAC通道小分子抑制剂，正在开发用于急性炎症和免疫疾病患者。CRAC通道存在于许多细胞类型上，包括免疫系统细胞，内皮细胞和胰腺腺泡细胞，这些通道的异常激活可能在急性和慢性炎症综合征的病理生物学中起关键作用。

Auxora is currently being evaluated in: (i) a Phase 2b trial for acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS), called CARPO, (ii) a Phase 2 trial in acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF), called KOURAGE, expected to initiate in the second quarter of 2024 and (iii) an investigator-sponsored Phase 1/2 trial, called CRSPA, being conducted in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT) as a side effect of pediatric acute lymphoblastic leukemia treatment with asparaginase.

Auxora目前正在进行评估：（i）急性胰腺炎（AP）伴全身炎症反应综合征（SIRS）的2b期临床试验，称为CARPO，（ii）急性肾损伤（AKI）伴急性低氧性呼吸衰竭（AHRF）的2期临床试验，称为KOURAGE，预计将于2024年第二季度启动；（iii）研究者赞助的1/2期临床试验，称为CRSPA，正在患有天冬酰胺酶诱导的胰腺毒性（AIPT）的儿科患者中进行，作为用天冬酰胺酶治疗小儿急性淋巴细胞白血病的副作用。

There are currently no approved therapies to treat either AP, AKI or AIPT. In previous trials, patients responded well to Auxora regardless of severity or cause of disease. CalciMedica is also exploring the potential of Auxora treatment for other acute indications including acute respiratory distress syndrome..

目前还没有批准的治疗AP，AKI或AIPT的疗法。在以前的试验中，无论严重程度或疾病原因如何，患者对Auxora的反应都很好。CalciMedica也在探索Auxora治疗其他急性适应症的潜力，包括急性呼吸窘迫综合征。。

About AP

关于AP

AP, or inflammation of the pancreas, can be a life-threatening condition. Moderate or severe AP sometimes leads to pancreatic cell death or necrosis, systemic inflammation, organ failure and death. There are an estimated 275,000 hospitalizations for AP annually in the United States, of which approximately 40% present with SIRS, a predictor of moderate and severe disease which can compromise the function of other tissues or organs, especially the lungs.

AP或胰腺炎症可能危及生命。中度或重度AP有时会导致胰腺细胞死亡或坏死，全身炎症，器官衰竭和死亡。据估计，美国每年有275000例AP住院治疗，其中约40%患有SIRS，SIRS是中度和重度疾病的预测因子，可损害其他组织或器官（尤其是肺部）的功能。

Organ failure is responsible for much of the mortality seen in AP. There is currently no approved therapy for AP. Details of the CARPO trial are available on clinicaltrials.gov (NCT04681066)..

器官衰竭是造成AP死亡的主要原因。目前还没有批准的AP治疗方法。有关CARPO试验的详细信息，请访问clinicaltrials.gov（NCT04681066）。。

About CalciMedica

关于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是一家临床阶段的生物制药公司，专注于开发针对炎症和免疫疾病的新型CRAC通道抑制疗法。CalciMedica的专有技术旨在抑制CRAC通道以调节免疫反应并防止组织细胞损伤，有可能为目前尚无批准疗法的威胁生命的炎症和免疫疾病提供治疗益处。

CalciMedica's lead product candidate Auxora™, a proprietary, intravenous-formulated CRAC channel inhibitor, has demonstrated positive and consistent clinical results in multiple completed efficacy clinical trials. CalciMedica is currently conducting a Phase 2b trial (called CARPO – NCT04681066) for AP with SIRS, with topline data expected in the second quarter of 2024, as well as supporting the ongoing Phase 1/2 AIPT study (called CRSPA – NCT04195347), with data expected in 2025.

CalciMedica的主要产品候选Auxora™是一种专有的静脉内配制的CRAC通道抑制剂，在多项已完成的疗效临床试验中显示出积极且一致的临床结果。CalciMedica目前正在进行一项针对SIRS的AP的2b期试验（称为CARPO–NCT04681066），预计2024年第二季度将有topline数据，并支持正在进行的1/2期AIPT研究（称为CRSPA–NCT04195347），预计2025年将有数据。

CalciMedica plans to initiate its Phase 2 study (called KOURAGE – NCT06374797) in AKI with associated AHRF in the second quarter of 2024 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.

CalciMedica计划于2024年第二季度在AKI启动其第二阶段研究（称为KOURAGE–NCT06374797），并与AHRF相关，预计数据将于2025年发布。CalciMedica由TorreyPines Therapeutics和哈佛CBR生物医学研究所的科学家创立，总部位于加利福尼亚州拉霍亚。