Calliditas Announces Positive NefIgArd Open Label Extension Results
Calliditas Announces Positive NefIgArd Open Label Extension Results
STOCKHOLM, April 24, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT), (NASDAQ STOCKHOLM: CALTX) ("Calliditas") today announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study across endpoints of urine protein to creatinine ration (UPCR) and estimated glomerular filtration rate (eGFR) at 9 months across all IgAN patients, including those who had previously received Nefecon in the NefIgArd study.
斯德哥爾摩，2024 年 4 月 24 日 /PRNewswire/ — Calliditas 治療公司 （納斯達克股票代碼：CALT），（納斯達克斯德哥爾摩：CALTX） （“Calliditas”）今天宣佈，對Nefigard3期研究的全球開放標籤延期（OLE）研究顯示，所有IgaN患者（包括之前在Nefigard研究中接受過NefeCon的患者）的尿蛋白與肌酐比例（UPCR）終點的治療反應與Nefigard的研究一致，以及估計的腎小球濾過率（eGFR）爲9個月。
NefIgArd was a global, Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of Nefecon 16 mg once daily vs placebo in adult patients with primary IgAN as an addition to optimized RASi therapy. Patients were randomized 1:1 to receive 16 mg/day of Nefecon or matching placebo for 9 months, followed by a 15-month observational follow-up period without the study drug. The NefIgArd study achieved both its primary and key secondary endpoints and was the basis for full approval by the FDA in December 2023. The full data set was published in The Lancet.
NefiGard是一項全球性3期、隨機、雙盲、安慰劑對照、多中心研究，旨在評估作爲優化RaSi療法補充原發性IgAn的成年患者的每日一次Nefecon 16 mg與安慰劑的療效和安全性。患者以 1:1 的隨機分配，接受每天16毫克的Nevecon或相應的安慰劑，爲期9個月，然後在不使用該研究藥物的情況下進行15個月的觀察隨訪。NefiGard研究達到了其主要和關鍵次要終點，是美國食品藥品管理局於2023年12月全面批准的基礎。完整的數據集發佈於 《柳葉刀》。
The OLE study was designed to provide 9 months of treatment with Nefecon for all patients who completed the NefIgArd study and who at that time had > 1g/g of proteinuria over 24h and > 30 ml/min of eGFR. All enrolled OLE patients continued on optimized RAS inhibitor therapy (ACEs and/or ARBs) and were treated for 9 months with Nefecon 16mg per day, with a follow-up visit three months after completion of treatment. Primary assessment was based on UPCR and eGFR at 9 months. A total of 119 patients were enrolled, of whom 45 had previously had active treatment.
OLE研究旨在爲所有完成NeviGard研究且當時在24小時內蛋白尿超過1g/g且表皮生長因子>30 ml/min的患者提供爲期9個月的Nefecon治療。所有入組的OLE患者繼續接受優化的RAS抑制劑療法（ACE和/或ARB），並接受了9個月的每天使用Nefecon 16mg的治療，並在治療結束三個月後進行隨訪。初步評估以9個月時的UPCR和eGFR爲基礎。共招收了119名患者，其中45人此前曾接受過積極治療。
Topline data from the OLE study showed that the treatment response was consistent with the NefIgArd study's findings regarding the endpoints of UPCR and eGFR at nine months across all patients, irrespective of whether they had previously been treated with Nefecon or with placebo. The safety data after 9 months of treatment or retreatment with Nefecon in patients who completed the NefIgArd study were consistent with previously reported safety data.
OLE研究的主要數據顯示，治療反應與NefiGard研究關於所有患者在九個月時UPCR和eGFR終點的發現一致，無論他們之前接受過Nefecon還是安慰劑治療。完成NefiGard研究的患者在接受Nefecon治療或再治療9個月後的安全數據與先前報告的安全性數據一致。
"It is exciting to see these results on both proteinuria reduction and eGFR stabilization at 9 months across all patients irrespective of previous treatment regimen in the Phase 3 trial,", said CEO Renée Aguiar-Lucander. "These topline results support the study thesis that the response to retreatment with Nefecon was unaffected by previous treatment cycles. We look forward to presenting data at the upcoming ERA EDTA symposium."
首席執行官蕾妮·阿吉亞爾-盧坎德說：“令人興奮的是，無論以前在3期試驗中採用了何種治療方案，所有患者的蛋白尿減少和表皮生長因子均穩定在9個月的水平。”“這些主要結果支持了這樣的研究論點，即對使用Nefecon再治療的反應不受先前治療週期的影響。我們期待在即將舉行的ERA EDTA研討會上展示數據。”
For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email: [email protected]
欲了解更多信息，請聯繫:
Asa Hillsten，Calliditas投資者關係與可持續發展主管
電話：+46 76 403 35 43，電子郵件：[email protected]
The information was sent for publication, through the agency of the contact persons set out above, on 24 April 2024 at 08:30 a.m. CET.
該信息已於歐洲中部時間2024年4月24日上午 08:30 通過上述聯繫人機構發送出版。
This information was brought to you by Cision
這些信息是由 Cision 帶給你的
The following files are available for download:
以下文件可供下載：
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OLE Data PR_ENG |
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OLE 數據 PR_ENG |
SOURCE Calliditas Therapeutics
來源 Calliditas 療法
譯文內容由第三人軟體翻譯。