STOCKHOLM, May 28, 2024 /PRNewswire/ -- Calliditas Therapeutics (Formerly known as Pharmalink) AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas'), today announced the presentations of an additional efficacy analysis of Nefecon (TARPEYO® (budesonide) delayed release capsules)) as well as a real-world analysis of the use of systemic glucocorticoids (SGC) in IgA nephropathy (IgAN).

斯德哥尔摩，2024年5月28日/PRNewswire/--Calliditas Therapeutics（以前称为Pharmalink）AB（纳斯达克：CALT）（纳斯达克-斯德哥尔摩：CALTX）（“Calliditas”）今天宣布介绍Nefecon（TARPEYO®（布地奈德）缓释胶囊）的额外疗效分析，以及在IgA肾病（IgAN）中使用全身糖皮质激素（SGC）的真实分析。

These were presented at ERA 2024 virtually and in Stockholm on May 23 - 26, 2024..

2024年5月23日至26日，在ERA 2024虚拟会议和斯德哥尔摩会议上展示了这些内容。。

The presented efficacy analysis of Nefecon and sparsentan showed that treatment with Nefecon for 9 months was associated with estimated glomerular filtration rate (eGFR) benefit compared with continuous treatment with sparsentan.

Nefecon和sparsentan的疗效分析表明，与持续使用sparsentan治疗相比，Nefecon治疗9个月与估计的肾小球滤过率（eGFR）获益相关。

Additionally, the findings of a real-world analysis of challenges associated with the use of systemic glucocorticoids demonstrate significant side effects and costs for IgAN patients treated with systemic glucocorticoids (SGC), such as Prednisone and Prednisolone.

此外，对使用全身性糖皮质激素相关挑战的现实分析结果表明，用全身性糖皮质激素（SGC）治疗的IgAN患者（如泼尼松和泼尼松龙）具有显着的副作用和成本。

'It was wonderful to participate in ERA 2024 and present data contributing to the discussion on the need for effective treatments in IgAN,' said Richard Philipson, Chief Medical Officer of Calliditas, ' We continue to gather evidence that highlights the importance of treating the underlying autoimmune pathogenesis associated with IgAN, and we believe TARPEYO, as the only approved immunomodulating therapy designed to target the production of Gd-IgA1, has the potential to become a cornerstone therapy in IgAN.'.

Calliditas首席医疗官理查德·菲利普森（Richard Philipson）说：“很高兴参加2024年的ERA，并提供有助于讨论IgAN有效治疗必要性的数据，我们继续收集证据，强调治疗与IgAN相关的潜在自身免疫发病机制的重要性，我们相信TARPEYO作为唯一被批准的免疫调节疗法，旨在针对Gd-IgA1的产生，有可能成为IgAN的基石疗法。”。

Poster presentation details are below and will be available on the Presentations and Publications page on the Calliditas' corporate website following the meeting.

海报展示详情如下，会后将在Calliditas公司网站的展示和出版物页面上提供。

Presentation Analyses:

演示文稿分析：

Title: 'Matching-adjusted indirect comparison of eGFR in patients with immunoglobulin A nephropathy treated with Nefecon (TRF budesonide) or sparsentan'

标题：“奈非康（TRF布地奈德）或斯巴森坦治疗的免疫球蛋白A肾病患者的eGFR匹配调整间接比较”

A matching-adjusted indirect comparison (MAIC) methodology is a widely accepted and relevant methodology for comparing treatments across trials in the absence of head-to-head comparisons. Here the effects of Nefecon, marketed as TARPEYO® and sparsentan, marketed as FILSPARI™, on kidney function deterioration in patients with IgAN were compared, as assessed by eGFR change from baseline at 9, 12 and 24 months.

匹配调整间接比较（MAIC）方法是一种广泛接受且相关的方法，用于在没有头对头比较的情况下比较试验中的治疗。在这里，通过9、12和24个月时eGFR从基线的变化评估，比较了以TARPEYO®和sparsentan销售的Nefecon对IgAN患者肾功能恶化的影响。

Results from the MAIC showed significantly favorable effects of Nefecon versus sparsentan on eGFR across all time points analyzed. Mean differences in the absolute change in eGFR of 5.68mL/min/1.73 m2 (95% credible interval [Crl] 3.14, 8.20; p<0.001), 3.48 mL/min/1.73 m2 (95% Crl 0.97, 5.97; p=0.006) and 3.28 mL/min/1.73 m2 (95% Crl 0.02, 6.51; p=0.048) were observed when comparing Nefecon with sparsentan at 9 months vs 36 weeks, 12 months vs 48 weeks, and 24 months vs 106 weeks, respectively.

MAIC的结果显示，在所有分析的时间点，Nefecon与sparsentan对eGFR的显着有利作用。在9个月与36周、12个月与48周、24个月与106周时，观察到eGFR绝对变化的平均差异分别为5.68mL/min/1.73 m2（95%可信区间[Crl]3.14、8.20；p＜0.001）、3.48 mL/min/1.73 m2（95%Crl 0.97、5.97；p＝0.006）和3.28 mL/min/1.73 m2（95%Crl 0.02、6.51；p＝0.048）。

This efficacy analysis showed that treatment with Nefecon 16 mg/day for 9 months was associated with greater eGFR benefit compared with continuous treatment with sparsentan 400 mg/day over 2 years, with significant differences observed as early as 9 months after treatment initiation and sustained up to 2-years of follow-up.

该疗效分析显示，与2年内持续使用司帕生坦400 mg/天治疗相比，奈非康16 mg/天治疗9个月与更大的eGFR获益相关，早在治疗开始后9个月就观察到显着差异，并持续长达2年的随访。

While the rigor of well-controlled head-to-head clinical trials cannot be replicated, MAIC is also a widely accepted and relevant methodology for comparing treatments across trials in the absence of head-to-head comparisons1,2, *..

虽然控制良好的头对头临床试验的严格性无法复制，但MAIC也是一种广泛接受且相关的方法，用于在没有头对头比较的情况下比较各试验的治疗方法1,2，*。。

Title: 'Real-world challenges associated with the use of systemic glucocorticoids in a US IgAN cohort'

标题：“在美国IgAN队列中使用全身性糖皮质激素的现实挑战”

Per Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, patients at high risk of progressive chronic kidney disease despite maximal supportive care can be considered for a 6-month course of systemic glucocorticoids (SGC), although important risks of toxicity and contraindications must be considered.

根据肾脏疾病：改善全球结局（KDIGO）指南，尽管有最大程度的支持治疗，但仍有进行性慢性肾脏疾病高风险的患者可以考虑为期6个月的全身糖皮质激素（SGC）疗程，尽管必须考虑重要的毒性和禁忌症风险。

There is currently limited real-world evidence describing the impact of the use of SGC on treatment-emergent toxicity and healthcare resource utilization (HCRU) in patients with IgAN. Our findings demonstrate significant side effects and costs for IgAN patients treated with SGC compared with patients not treated with SGC.

目前，描述使用SGC对IgAN患者治疗紧急毒性和医疗资源利用（HCRU）的影响的现实证据有限。我们的研究结果表明，与未接受SGC治疗的患者相比，接受SGC治疗的IgAN患者具有显着的副作用和成本。

Increases in severe infection incidents, inpatient visits, emergency department admissions, and ambulatory visits, underscore the careful consideration of treatment-emergent toxicity prior to initiating SGC therapy in patients with IgAN..

严重感染事件，住院病人就诊，急诊科入院和门诊就诊的增加强调了在IgAN患者开始SGC治疗之前仔细考虑治疗紧急毒性。。

*The optimization strategy in NefIgArd (optimized RASi) differed from the optimization strategy in PROTECT (IR), and anchoring of the two trials at optimized RASi/IR might lead to biased results. However, we also evaluated an unanchored MAIC in a sensitivity analysis and found very similar results.

*NefIgArd（优化的RASi）中的优化策略不同于PROTECT（IR）中的优化策略，并且将两个试验锚定在优化的RASi/IR可能导致有偏差的结果。然而，我们还在敏感性分析中评估了未经调试的MAIC，发现了非常相似的结果。

The MAIC method can only adjust the relative effect estimates for any observed effect modifier available in the data, but it cannot adjust for unobserved or unobservable effect modifiers. A significant number of potential treatment effect modifiers were included in the present analysis: age, sex, race, baseline eGFR, UPCR, UACR, and urinary protein excretion..

MAIC方法只能调整数据中可用的任何观察到的效应修正因子的相对效应估计，但不能调整未观察到或不可观察的效应修正因子。本分析包括大量潜在的治疗效果调节剂：年龄，性别，种族，基线eGFR，UPCR，UACR和尿蛋白排泄。。

Indication

指示

TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

TARPEYO被认为可以减少患有原发性免疫球蛋白A肾病（IgAN）且有疾病进展风险的成年人的肾功能丧失。

Important Safety Information

重要安全信息

Contraindications: TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis, have occurred with other budesonide formulations.

禁忌症：对布地奈德或TARPEYO的任何成分过敏的患者禁用TARPEYO。其他布地奈德制剂也发生了严重的超敏反应，包括过敏反应。

Warnings and Precautions

警告和注意事项

Hypercorticism and adrenal axis suppression: When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended.

皮质类固醇激素和肾上腺轴抑制：长期使用皮质类固醇激素时，可能会出现皮质类固醇激素和肾上腺抑制等全身效应。皮质类固醇可以降低下丘脑-垂体-肾上腺（HPA）轴对压力的反应。在患者接受手术或其他压力情况下，建议补充全身皮质类固醇。

When discontinuing therapy or switching between corticosteroids, monitor for signs of adrenal axis suppression..

停止治疗或更换皮质类固醇时，监测肾上腺轴抑制的迹象。。

Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C).

由于口服布地奈德的全身暴露增加，中度至重度肝功能损害（分别为Child-Pugh B级和C级）的患者可能会增加皮质醇增多症和肾上腺轴抑制的风险。避免用于严重肝损伤患者（Child-Pugh C级）。

Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B)..

监测中度肝功能损害（Child-Pugh B级）患者皮质醇增多的体征和/或症状。。

Risks of immunosuppression: Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressive doses of corticosteroids.

免疫抑制的风险：服用抑制免疫系统药物的患者比健康人更容易感染。例如，水痘和麻疹在易感患者或服用免疫抑制剂量皮质类固醇的患者中可能会有更严重甚至致命的病程。

Avoid corticosteroid therapy in patients with active or quiescent tuberculosis infection; untreated fungal, bacterial, systemic viral, or parasitic infections, or ocular herpes simplex. Avoid exposure to active, easily transmitted infections (e.g., chicken pox, measles). Corticosteroid therapy may decrease the immune response to some vaccines..

避免对活动性或静止性结核感染患者进行皮质类固醇治疗；未经治疗的真菌，细菌，全身病毒或寄生虫感染或眼部单纯疱疹。避免接触活动性、易传播的感染（如水痘、麻疹）。皮质类固醇治疗可能会降低对某些疫苗的免疫反应。。

Other corticosteroid effects: TARPEYO is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients with hypertension, prediabetes, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects..

其他皮质类固醇作用：TARPEYO是一种全身可用的皮质类固醇，预计会引起相关的不良反应。监测患有高血压，糖尿病前期，糖尿病，骨质疏松症，消化性溃疡，青光眼或白内障，或有糖尿病或青光眼家族史，或皮质类固醇可能产生不良影响的任何其他疾病的患者。。

Adverse reactions: In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%)..

不良反应：在临床研究中，TARPEYO最常见的不良反应（发生率≥5%，比安慰剂高≥2%）是外周水肿（17%），高血压（12%），肌肉痉挛（12%），痤疮（11%），头痛（10%），上呼吸道感染（8%），面部水肿（8%），体重增加（7%），消化不良（7%），皮炎（6%），关节痛（6%），白细胞计数增加（6%）。。

Drug interactions: Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase the systemic exposure to budesonide..

药物相互作用：布地奈德是CYP3A4的底物。避免使用强效CYP3A4抑制剂，如酮康唑、伊曲康唑、利托那韦、茚地那韦、沙奎那韦、红霉素和环孢素。避免摄入含TARPEYO的葡萄柚汁。摄入抑制CYP3A4活性的葡萄柚汁可以增加布地奈德的全身暴露。。

Use in specific populations

在特定人群中使用

Pregnancy: The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with IgAN.

怀孕：已发表的病例系列，流行病学研究以及孕妇口服布地奈德的评论的现有数据尚未确定与药物相关的重大出生缺陷，流产或其他不良孕产妇或胎儿结局的风险。与IgAN相关的母亲和胎儿存在风险。

Infants exposed to in-utero corticosteroids, including budesonide, are at risk for hypoadrenalism..

暴露于子宫内皮质类固醇（包括布地奈德）的婴儿有肾上腺功能减退的风险。。

Please see Full Prescribing Information.

请参阅完整的处方信息。

About TARPEYO

关于TARPEYO

TARPEYO is an oral 4mg delayed release formulation of budesonide, designed to remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer's patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy..

TARPEYO是一种口服4mg布地奈德缓释制剂，旨在保持完整直至到达回肠。每个胶囊含有布地奈德的包被珠子，其靶向回肠中存在的粘膜B细胞，包括派伊尔斑，其负责产生导致IgA肾病的半乳糖缺陷型IgA1抗体（Gd-Ag1）。。

About Primary Immunoglobulin A Nephropathy

关于原发性免疫球蛋白A肾病

Primary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger's Disease) is a rare, progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose deficient IgA1 is recognized by autoantibodies, creating IgA1 immune complexes that become deposited in the glomerular mesangium of the kidney.

原发性免疫球蛋白A肾病（IgA肾病或IgAN或伯格氏病）是一种罕见的进行性慢性自身免疫性疾病，可攻击肾脏，当半乳糖缺乏的IgA1被自身抗体识别时发生，产生IgA1免疫复合物，沉积在肾脏的肾小球系膜中。

This deposition in the kidney can lead to progressive kidney damage and potentially a clinical course resulting in end- stage renal disease. IgAN most often develops between late teens and late 30s..

肾脏中的这种沉积可能导致进行性肾脏损伤，并可能导致终末期肾脏疾病的临床过程。IgAN通常在十几岁到三十岁之间发展。。

For further information, please contact:

欲了解更多信息，请联系：

Åsa Hillsten, Head of IR & Sustainability, Calliditas

Ása Hillsten，Calliditas IR和可持续发展负责人

Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com

电话：+46 76 403 35 43，电子邮件：asa.hillsten@calliditas.com

The information was sent for publication, through the agency of the contact persons set out above, on May 28, 2024, at 14.00 p.m. CET.

该信息于2024年5月28日下午14:00通过上述联系人的机构发送发布。

This information was brought to you by Cision http://news.cision.com.

此信息由Cision提供给您http://news.cision.com.

https://news.cision.com/calliditas-therapeutics/r/calliditas-therapeutics-presents-data-at-the-61-st--european-renal-association-congress,c3988529

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The following files are available for download:

以下文件可供下载：

https://mb.cision.com/Main/16574/3988529/2822572.pdf

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SOURCE Calliditas Therapeutics

源Callidites疗法

Company Codes: Stockholm:CALTX, NASDAQ-NMS:CALT, Bloomberg:CALTX@SS, ISIN:SE0010441584, RICS:CALTX.ST

公司代码：斯德哥尔摩：CALTX，NASDAQ-NMS：CALT，彭博社：CALTX@SS，ISIN:SE0010441584，RICS:CALTX。圣