STOCKHOLM, April 18, 2024 /PRNewswire/ -- Calliditas Therapeutics (Formerly known as Pharmalink) (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas'), today announced additional data analyses from the 2-year Phase 3 NeflgArd trial evaluating Nefecon (TARPEYO® (budesonide) delayed-release capsules/Kinpeygo®) in patients with IgA nephropathy (IgAN), were presented at the ISN World Congress of Nephrology in Buenos Aires, Argentina on April 13-16, 2024..

斯德哥尔摩，2024年4月18日/PRNewswire/--Calliditas Therapeutics（以前称为Pharmalink）（纳斯达克：CALT）（纳斯达克-斯德哥尔摩：CALTX）（“Calliditas”）今天宣布了为期2年的3期NeflgArd试验的额外数据分析，该试验评估了IgA肾病（IgAN）患者的Nefecon（TARPEYO®（布地奈德）缓释胶囊/Kinpeygo®），于2024年4月13日至16日在阿根廷布宜诺斯艾利斯举行的IS世界肾病大会上发表。。

'We were pleased to share additional analyses from the 2-year Phase 3 NeflgArd trial of Nefecon in IgAN at this year's World Congress of Nephrology,' said Richard Philipson, Chief Medical Officer of Calliditas. 'These additional data further reinforce the impact of Nefecon across the entire study population, irrespective of baseline UPCR levels or patient's racial and ethnic backgrounds.'.

Calliditas首席医学官理查德·菲利普森（RichardPhilipson）说：“我们很高兴在今年的世界肾脏病大会上分享为期2年的IgAN奈非康3期临床试验的更多分析。”这些额外的数据进一步加强了Nefecon对整个研究人群的影响，无论基线UPCR水平或患者的种族和民族背景如何。”。

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。

Poster Presentation Analyses:

海报展示分析：

Poster Title: 'Nefecon treatment provides kidney benefits for patients with IgAN that extend to those with low levels of UPCR: A sub-analysis of the phase III NefIgArd trial'

海报标题：“Nefecon治疗为IgAN患者提供肾脏益处，并扩展到UPCR水平低的患者：NefIgArd III期试验的子分析”

An extended analysis of patients with baseline UPCR levels above and below 0.8 g/g was performed to further explore the potential benefits of Nefecon. In the full analysis involving 364 patients regardless of baseline UPCR, Nefecon treatment consistently improved the estimated glomerular filtrate rate (eGFR) over the 2-year study period compared to placebo.

对基线UPCR水平高于和低于0.8 g/g的患者进行了扩展分析，以进一步探索奈非康的潜在益处。在涉及364名患者的完整分析中，无论基线UPCR如何，与安慰剂相比，奈非康治疗在2年的研究期间始终提高了估计的肾小球滤过率（eGFR）。

72 patients with a baseline UPCR <0.8 g/g experienced sustained eGFR improvement (p=0.0026), which persisted for up to 18 months after treatment initiation, even after the treatment cessation at month 9.  Those patients also achieved an eGFR slope of -0.25 mL/min/1.73 m2 per year, indicating that Nefecon treatment may support them in reaching the RaDaR treatment target of an eGFR decline of <1 mL/min/1.73 m2 per year.

72名基线UPCR<0.8 g/g的患者经历了持续的eGFR改善（p=0.0026），即使在第9个月停止治疗后，eGFR也持续了18个月。这些患者的eGFR斜率也达到了-0.25 mL/min/1.73 m2每年，这表明Nefecon治疗可能支持他们达到每年eGFR下降<1 mL/min/1.73 m2的雷达治疗目标。

This objective is pivotal in mitigating the risk of kidney failure in their lifetime..

这一目标对于降低其一生中肾衰竭的风险至关重要。。

Poster Title: 'eGFR decline in patients with IgAN treated with Nefecon or placebo: Results from the 2-year NefIgArd Phase 3 trial'

海报标题：“用Nefecon或安慰剂治疗的IgAN患者的eGFR下降：2年NefIgArd 3期试验的结果”

During the 9-month treatment period, Nefecon showed a 30% reduction in UPCR compared to the placebo, sustained for 2 years. The percentage of patients with a confirmed 30% reduction in eGFR or kidney failure was lower in the Nefecon arm compared to placebo, and the time to such events was significantly delayed with Nefecon (hazard ratio [HR] 0.45; 95% confidence interval 0.26, 0.75]; p=0.0014 [1-sided]).

在9个月的治疗期间，与安慰剂相比，Nefecon的UPCR降低了30%，持续了2年。与安慰剂组相比，Nefecon组eGFR或肾功能衰竭确诊率降低30%的患者百分比较低，Nefecon组发生此类事件的时间显着延迟（风险比[HR]0.45；95%置信区间0.26，0.75]；p=0.0014[1侧]）。

Supplementary analysis with rescue medication yielded similar results, irrespective of the handling of rescue medication: Rescue medication counted as an event: HR 0.51 (95% CI 0.33, 0.79), Regardless of rescue medication: HR 0.44 (95% CI 0.27, 0.71). The treatment effect of Nefecon on the risk of kidney function decline was consistent regardless of baseline UPCR.

救援药物的补充分析产生了类似的结果，无论救援药物的处理如何：救援药物被视为事件：HR 0.51（95%CI 0.33，0.79），无论救援药物：HR 0.44（95%CI 0.27，0.71）。无论基线UPCR如何，奈非康对肾功能下降风险的治疗效果是一致的。

These findings strongly suggest preserved kidney function and provide support for Nefecon as a disease-modifying therapy in patients with IgAN..

这些发现强烈表明保留了肾功能，并为奈非康作为IgAN患者的疾病缓解疗法提供了支持。。

Poster Title: Nefecon effect on quality of life in patients with IgAN: SF-36 results from the Phase 3 NefIgArd trial'

海报标题：Nefecon对IgAN患者生活质量的影响：NefIgArd 3期试验的SF-36结果

The 2-year results of quality of life (QoL) analyses based on 36-Item Short Form Survey (SF-36) assessments at 9 and 24 months revealed no meaningful differences in any QoL domain between Nefecon and placebo groups after 9 months of treatment. These SF-36 scores remained consistent after 15 months of off-drug observational follow-up further supporting the benefit/risk profile of Nefecon..

基于9个月和24个月的36项简式调查（SF-36）评估的2年生活质量（QoL）分析结果显示，治疗9个月后，奈非康组和安慰剂组之间的任何QoL领域均无显着差异。经过15个月的非药物观察随访，这些SF-36评分保持一致，进一步支持了奈非康的益处/风险概况。。

Poster Title: 'Nefecon treatment response in Asian and White patient populations with immunoglobulin A nephropathy: A 2-year analysis of the Phase 3 NefIgArd trial'

海报标题：“亚洲和白人免疫球蛋白A肾病患者群体的Nefecon治疗反应：NefIgArd 3期试验的2年分析”

The responses to Nefecon treatment from the full 2-year NefIgArd trial were assessed in patients identifying as Asian (n=83) or White (n=275). Regardless of race and ethnicity, Nefecon showed a favorable change in eGFR compared to placebo of 5.5 mL/min/1.73 m2 in Asian patients and 4.8 mL/min/1.73 m2 in White patients.

在确定为亚洲人（n=83）或白人（n=275）的患者中评估了为期2年的NefIgArd试验对Nefecon治疗的反应。无论种族和种族如何，与安慰剂相比，Nefecon在亚洲患者中的eGFR变化良好，为5.5 mL/min/1.73 m2，在白人患者中为4.8 mL/min/1.73 m2。

Nefecon also demonstrated greater reductions in UPCR at 9 and 24 months with notable delays in kidney function decline events. These effects were consistent across races and ethnicities. Additionally, Nefecon significantly reduced the rate of microhematuria in both Asian and White patients. Overall, these findings highlight Nefecon's efficacy and tolerability across different racial and ethnic groups..

Nefecon在9个月和24个月时也表现出更大的UPCR降低，肾功能下降事件明显延迟。这些影响在种族和种族之间是一致的。此外，Nefecon显着降低了亚洲人和白人患者的微血尿发生率。总的来说，这些发现突出了Nefecon在不同种族和族裔群体中的功效和耐受性。。

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.  .

当停止治疗或在皮质类固醇之间转换时，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 the NeflgArd Study

关于NeflgArd研究

NefIgArd was a global, Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of TARPEYO 16 mg once daily vs placebo in adult patients with primary IgAN (N=364) as an addition to optimized RASi therapy. Patients were randomized 1:1 to receive 16 mg/day oral capsules of TARPEYO or matching placebo for 9 months, followed by a 15-month observational follow-up period without the study drug..

NefIgArd是一项全球性的3期随机双盲安慰剂对照多中心研究，旨在评估TARPEYO 16 mg每日一次与安慰剂对成人原发性IgAN患者（N=364）的疗效和安全性，作为优化RASi治疗的补充。患者以1:1的比例随机接受16毫克/天的TARPEYO口服胶囊或匹配的安慰剂治疗9个月，然后进行15个月的观察随访，无需研究药物。。

The primary efficacy endpoint was time-weighted average of eGFR over 2 years. The time-weighted average of eGFR over 2 years showed a statistically significant treatment benefit with TARPEYO versus placebo (difference 5•05 mL/min per 1•73 m² [95% CI 3•24 to 7•38], p<0•0001).

主要疗效终点是2年内eGFR的时间加权平均值。2年内eGFR的时间加权平均值显示，TARPEYO与安慰剂相比具有统计学意义的治疗益处（每1.73平方米差异5.05毫升/分钟[95%可信区间3.24至7.38]，p<0.0001）。

The favorable effect of TARPEYO on eGFR was seen by Month 3 (the earliest assessment) and did not appear to increase in magnitude over two years.  At the end of Year 2, there was a 5.9 mL/min/1.73 m2 difference in the mean change from baseline in eGFR between TARPEYO and placebo (95% CI: 3.3 to 8.5 mL/min/1.73 m2; p<0.0001).

TARPEYO对eGFR的有利影响在第3个月（最早的评估）就已经出现，并且在两年内似乎没有增加。在第2年末，TARPEYO和安慰剂组eGFR的平均变化与基线相比有5.9 mL/min/1.73 m2的差异（95%CI:3.3至8.5 mL/min/1.73 m2；p＜0.0001）。

The effect on kidney function seen during the 9-month treatment period persisted following completion of treatment through the end of the study but the overall effect on the long-term rate of decline has not been established..

9个月治疗期间对肾功能的影响在治疗结束后一直持续到研究结束，但对长期下降率的总体影响尚未确定。。

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 increase (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increase (6%)..

TARPEYO最常见的不良反应是外周水肿（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%）和白细胞计数增加（6%）。。

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.This deposition in the kidney can lead to progressive kidney damage and potentially a clinical course resulting in end- stage renal disease.

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。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 most often develops between late teens and late 30s..

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 April 18, 2023, at 13.00 p.m. CET.

2023年4月18日，欧洲中部时间下午13:00，通过上述联系人的代理机构将该信息发送出版。

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