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Viking Therapeutics to Present Data From Phase 2b VOYAGE Study of VK2809 in Patients With Biopsy-Confirmed NASH/MASH at the 75th Liver Meeting 2024

Viking Therapeutics to Present Data From Phase 2b VOYAGE Study of VK2809 in Patients With Biopsy-Confirmed NASH/MASH at the 75th Liver Meeting 2024

viking therapeutics將在2024年第75屆肝病會議上,介紹VK2809在經活檢證實的NASH/MASH患者中進行的第20億期VOYAGE研究的數據。
PR Newswire ·  11/13 05:05

Results to be Featured in Oral Late Breaker Presentation

成果將在口頭的晚點特色板塊中展示

SAN DIEGO, Nov. 12, 2024 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that results from the company's Phase 2b clinical trial of VK2809, the company's novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH; also referred to as metabolic dysfunction associated steatohepatitis, MASH) will be highlighted in an oral late breaker presentation at the 75th Liver Meeting 2024, the annual meeting of the American Association for the Study of Liver Disease (AASLD).  The Liver Meeting 2024 is being held November 15-19, 2024, in San Diego, California.

聖地亞哥,2024年11月12日/ PRNewswire/ - Viking Therapeutics, Inc.(「Viking」)(納斯達克:VKTX),一家專注於開發新型治療代謝和內分泌疾病的臨床階段生物製藥公司,今天宣佈了該公司VK2809的第20億臨床試驗結果,該試驗是該公司的新型肝臟選擇性甲狀腺激素受體β激動劑,針對經活檢確認的非酒精性脂肪肝(NASH;也稱代謝紊亂相關性脂肪肝,MASH)患者,將在納斯達克(AASLD)第75屆肝臟年會上以口頭形式作爲晚發表重要研究成果。2024年肝臟年會將於2024年11月15-19日在美國加利福尼亞州聖地亞哥舉行。

Details of the oral presentation are as follows:

口頭報告的詳細信息如下:

Title: Results from the 52-Week Phase 2b VOYAGE Trial of VK2809 in Patients with Biopsy-Confirmed Non-Alcoholic Steatohepatitis and Fibrosis: A Randomized, Placebo-Controlled Trial

標題:VK2809用於經活檢確認的非酒精性脂肪肝和纖維化患者的52周第20億VOYAGE試驗結果:一項隨機、安慰劑對照試驗

Presenting Author: Rohit Loomba, M.D., MHSc, Director, NAFLD Research Center and Professor of Medicine, University of California, San Diego

主講者:Rohit Loomba萬.D.,MHSc,NAFLD研究中心主任,加州大學聖地亞哥分校醫學教授

Session: Late Breaking Abstract Parallel Session 3

會議:晚發表摘要並行分會議3

Date/Time: Tuesday, November 19, 2024, 11:00 – 11:10 a.m. Pacific Time

日期/時間:2024年11月19日星期二,上午11:00 - 11:10(太平洋時間)

Location: San Diego Convention Center

地點:聖地亞哥會議中心

About VK2809

關於VK2809

VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid hormone beta receptor (TRβ) that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of lipid disorders. The Phase 2b VOYAGE study of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH; also referred to as metabolic dysfunction associated steatohepatitis, MASH) and fibrosis successfully achieved both the trial's primary and secondary endpoints. VK2809 also successfully achieved primary and secondary endpoints in a Phase 2a study for the treatment of patients with elevated LDL-C and non-alcoholic fatty liver disease (NAFLD). Selective activation of the thyroid hormone beta receptor in liver tissue is believed to favorably affect cholesterol and lipoprotein levels via multiple mechanisms, including increasing the expression of genes associated with lipid metabolism and clearance.  

VK2809是一種口服藥物,對甲狀腺激素β受體(TRβ)具有組織和受體亞型選擇性激動劑,對肝臟組織以及β受體亞型具有選擇性,表明在一系列脂質紊亂中具有有望的治療潛力。VK2809用於經活檢證實爲非酒精性脂肪性肝炎(NASH;也稱爲代謝功能障礙性脂肪性肝炎,MASH)和纖維化的患者進行的20億VOYAGE研究成功實現了試驗的主要和次要終點。VK2809還在針對LDL-C升高和非酒精性脂肪肝病(NAFLD)患者的2a期研究中成功實現了主要和次要終點。相信在肝臟組織中選擇性激活甲狀腺激素β受體有利於通過多種機制對膽固醇和脂蛋白水平產生積極影響,包括增加與脂質代謝和清除相關的基因表達。

About Viking Therapeutics, Inc.

美國維京療法公司是一家臨床階段的生物製藥公司,專注於開發治療代謝和內分泌疾病的新型療法。

Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking's clinical programs include VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. Data from a Phase 1 and a Phase 2 trial evaluating VK2735 (dosed subcutaneously) for metabolic disorders demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. Concurrently, the company is evaluating an oral formulation of VK2735 in a Phase 1 trial. Viking is also developing VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a recently completed Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH; also referred to as metabolic dysfunction associated steatohepatitis, MASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo.  The company's newest program is evaluating a series of internally developed dual amylin and calcitonin receptor agonists (or DACRAs) for the treatment of obesity and other metabolic disorders.  In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD).  In a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD, VK0214 was shown to be safe and well-tolerated, while driving significant reductions in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo.

Viking Therapeutics,Inc.是一家臨床階段的生物製藥公司,專注於開發用於治療代謝和內分泌疾病的新型一類或最佳一類療法,目前有三種化合物處於臨床試驗階段。Viking的研發活動利用其在代謝方面的專業知識,開發創新治療藥物,旨在改善患者的生活。Viking的臨床項目包括VK2735,一種新型的胰高血糖素樣肽1(GLP-1)和葡萄糖依賴性胰島素增敏性多肽(GIP)受體的雙激動劑,用於潛在治療多種代謝障礙。針對代謝疾病進行VK2735(亞切割劑量)的1期和2期試驗數據表明其具有令人鼓舞的安全性和耐受性前景以及臨床益處的積極跡象。與此同時,該公司正在進行VK2735口服制劑的1期試驗。Viking還在開發VK2809,一種新型的口服小分子選擇性甲狀腺激素受體β激動劑,用於治療脂質和代謝紊亂。該化合物在最近完成的針對活檢證實的非酒精性脂肪性肝炎(NASH;也稱爲代謝功能障礙性脂肪性肝炎,MASH)和纖維化治療的20億期研究中成功實現了主要和次要終點。在針對非酒精性脂肪肝病(NAFLD)和LDL-C升高的2a期試驗中,接受VK2809治療的患者與接受安慰劑的患者相比, LDL-C和肝脂含量均顯着下降。公司最新的項目是評估一系列內部開發的雙澱粉樣蛋白和降鈣血素受體激動劑(或DACRA)用於肥胖和其他代謝性疾病的治療。在罕見疾病領域,Viking正在開發VK0214,一種新型的口服小分子選擇性甲狀腺激素受體β激動劑,用於潛在治療X連鎖腎上腺白質變性(X-ALD)。在對具有X-ALD的腎上腺脊髓病(AMN)形式患者進行的10億期臨床試驗中,VK0214顯示出安全且耐受良好,同時相較於安慰劑,顯著降低了血漿中的非極長鏈脂肪酸(VLCFA)和其他脂類水平。

SOURCE Viking Therapeutics, Inc.

來源:美國維京療法公司。

譯文內容由第三人軟體翻譯。


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