Late Breaking Poster Presentation Reports New Results Demonstrating Robust Liver Fat Reductions Across Key Subgroups, Including Patients with Type 2 Diabetes and Among Those with F2 or F3 Fibrosis

最新的海报展示报告显示了关键亚组（包括2型糖尿病患者和F2或F3纤维化患者）肝脏脂肪减少的新结果

Presentation also Highlights Previously Reported Results Showing Successful Achievement of Study's Primary Endpoint, Statistically Significant Liver Fat Reductions from Baseline to Week 12 Among Patients Receiving VK2809

报告还重点介绍了先前报告的结果，这些结果显示成功实现了研究的主要终点，在接受VK2809的患者中，从基线到第12周肝脏脂肪减少具有统计学意义

52-Week Biopsy Results Expected 1H 2024

52周活检结果预计1H 2024

SAN DIEGO, Nov. 13, 2023 /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 the presentation of new results from the ongoing 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).

圣地亚哥，2023年11月13日/PRNewswire/--Viking Therapeutics，Inc。（'Viking'）（纳斯达克股票代码：VKTX），一家专注于开发代谢和内分泌疾病新疗法的临床阶段生物制药公司，今天宣布该公司新型肝选择性甲状腺激素受体β激动剂VK2809正在进行的2b期临床试验的新结果，在活检证实为非酒精性脂肪性肝炎（NASH）的患者中。

The latest findings from the VOYAGE study were featured in a late breaking poster presentation at the Liver Meeting® 2023, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), which is being held November 10-14, 2023, in Boston..

航程研究的最新发现在2023年11月10日至14日举行的美国肝病研究协会（AASLD）年会肝脏会议®2023上的最新海报展示中得到了特色。，在波士顿。。

As previously reported, the VOYAGE study successfully achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to Week 12 as compared with placebo. Newly reported findings demonstrated robust and comparable liver fat reductions among patients with or without type 2 diabetes, as well as patients with either F2 or F3 fibrosis.

如先前报道，VOYAGE研究成功实现了其主要终点，与安慰剂相比，接受VK2809的患者从基线到第12周的肝脏脂肪含量在统计学上显着降低。新报道的研究结果表明，患有或不患有2型糖尿病的患者以及患有F2或F3纤维化的患者肝脏脂肪减少强劲且相当。

These data demonstrate that VK2809's potential therapeutic activity is not meaningfully impacted by the presence of type 2 diabetes or by patients' stage of fibrosis. The data are important as the presence of liver fat and associated lipotoxicity are believed to play a contributing role in the onset and progression of NASH..

这些数据表明，VK2809的潜在治疗活性不受2型糖尿病的存在或患者纤维化阶段的有意义影响。数据很重要，因为肝脏脂肪的存在和相关的脂毒性被认为在NASH的发生和发展中起作用。。

Highlights from the AASLD presentation include:

AASLD演示文稿的重点包括：

Primary Endpoint: Reduction in Liver Fat Content at 12 Weeks

主要终点：12周时肝脏脂肪含量降低

Patients receiving VK2809 experienced statistically significant reductions in liver fat content, as assessed by magnetic resonance imaging, proton density fat fraction (MRI-PDFF) relative to placebo after 12 weeks of treatment.  The median relative reduction from baseline in liver fat ranged from 38% to 55% for patients receiving VK2809.

在治疗12周后，通过磁共振成像，质子密度脂肪分数（MRI-PDFF）相对于安慰剂评估，接受VK2809的患者肝脏脂肪含量在统计学上显着降低。接受VK2809的患者肝脏脂肪相对于基线的中位数相对减少范围为38%至55%。

Importantly, up to 85% of patients receiving VK2809 experienced at least a 30% relative reduction in liver fat content, a level of reduction that is associated with a greater likelihood of histologic response in NASH..

重要的是，高达85%的接受VK2809的患者肝脏脂肪含量相对降低至少30%，这种降低水平与NASH组织学反应的可能性更大有关。。

Placebo (n = 62)

安慰剂（n=62）

VK2809 1 mg QD (n = 17)3,4

VK2809 1 mg QD（n=17）3.4

VK2809 2.5 mg QD (n = 58)

VK2809 2.5 mg QD（n=58）

VK2809 5 mg QOD (n = 36)4

VK2809 5 mg QOD（n=36）4

VK2809 10 mg QOD (n = 56)

VK2809 10 mg QOD（n=56）

Mean baseline liver fat content

平均基线肝脏脂肪含量

20.4 %

20.4 %

21.7 %

21.7 %

20.2 %

20.2 %

18.4 %

18.4 %

21.5 %

21.5 %

Mean relative change in liver fat by MRI-PDFF1,2

MRI-PDFF1,2对肝脏脂肪的平均相对变化

-3.7 %

-3.7 %

-16.6% (p=0.082)

-16.6%（p=0.082）

-45.3% (p<0.0001)

-45.3%（p<0.0001）

-36.8% (p<0.0001)

-36.8%（p<0.0001）

-51.7% (p<0.0001)

-51.7%（p0.0001）

Median relative change in liver fat

肝脏脂肪中位数相对变化

-5.4 %

-5.4 %

-37.5 %

-37.5 %

-48.1 %

-48.1 %

-42.5 %

-42.5 %

-55.1 %

-55.1 %

Percentage of patients experiencing ≥ 30% reduction in liver fat2

肝脂肪减少≥30%的患者百分比2

13.6 %

13.6 %

52.9% (p=0.0015)

52.9%（p 0.0015）

77.6% (p<0.0001)

77.6%（p0.0001）

66.7% (p<0.0001)

66.7%（p<0.0001）

84.9% (p<0.0001)

84.9%（p0.0001）

Notes: Data from Full Analysis Dataset, defined as all randomized patients who received a baseline and post-baseline MRI. 1) Least squares mean change from baseline using an Analysis of Covariance (ANCOVA) model. 2) p-value vs. placebo. 3) Reduced size cohort intended to identify a minimally effective dose.

注意：来自完整分析数据集的数据，定义为接受基线和基线后MRI的所有随机患者。1） 使用协方差分析（ANCOVA）模型从基线开始的最小二乘均值变化。2） p值与安慰剂。3） 旨在确定最低有效剂量的缩小队列。

4) Enrollment suspended at approximately 50% of target to accelerate study completion..

4） 入学人数暂停在目标的约50%，以加快学习完成。。

Among patients with type 2 diabetes, reductions from baseline in liver fat were reported for all VK2809 cohorts, ranging from 36% to 54% at Week 12. The effect size among patients with type 2 diabetes was comparable to that reported for patients without type 2 diabetes. Among non-diabetics, reductions in liver fat from baseline ranged from 19% to 51%.

在2型糖尿病患者中，所有VK2809队列的肝脏脂肪均从基线降低，在第12周时从36%降至54%。2型糖尿病患者的疗效大小与无2型糖尿病患者的疗效相当。在非糖尿病患者中，肝脏脂肪从基线减少19%至51%。

These data suggest that activation of the thyroid hormone beta receptor remains effective at reducing liver fat in the presence of an important metabolic comorbidity commonly observed in patients with NASH..

这些数据表明，在NASH患者常见的重要代谢合并症存在下，甲状腺激素β受体的激活在减少肝脏脂肪方面仍然有效。。

Mean Reduction in Liver Fat Content at 12 Weeks in Patients With and Without Type 2 Diabetes

有和没有2型糖尿病的患者在12周时肝脏脂肪含量的平均降低

Placebo

安慰剂

VK2809 1 mg QD

VK2809 1 mg，每日一次

VK2809 2.5 mg QD

VK2809 2.5 mg QD

VK2809 5 mg QOD

VK2809 5 mg每日一次

VK2809 10 mg QOD

VK2809 10 mg每日一次

Patients with Type 2 Diabetes

2型糖尿病患者

2.1 %

2.1 %

-35.8%*

-35.8%*

-43.1%***

-43.1%***

-39.5%***

-39.5%***

-53.9%***

-53.9%***

Patients without Type 2 Diabetes

没有2型糖尿病的患者

-6.2 %

-6.2 %

-19.4 %

-19.4 %

-47.0%***

-47.0%***

-33.9%***

-33.9%***

-51.2%***

-51.2%***

Mean relative % change in liver fat at 12 weeks among patients with and without type 2 diabetes. *p<0.05, ***p<0.001 vs. placebo.

有和没有2型糖尿病的患者在12周时肝脏脂肪的平均相对%变化*与安慰剂相比，＃p<0.05，***p<0.001。

Treatment with VK2809 also demonstrated potent reductions in liver fat content among patients with either F2 or F3 fibrosis. Consistent with the efficacy observed among diabetics and non-diabetics, these data suggest that VK2809 maintains potency across a range of fibrosis stages.

VK2809治疗还显示出F2或F3纤维化患者的肝脏脂肪含量有效降低。与在糖尿病患者和非糖尿病患者中观察到的功效一致，这些数据表明VK2809在一系列纤维化阶段均保持效力。

Mean Reduction in Liver Fat Content at 12 Weeks in Patients With F2 or F3 Fibrosis

F2或F3纤维化患者12周时肝脏脂肪含量平均降低

Placebo

安慰剂

VK2809 1 mg QD

VK2809 1 mg，每日一次

VK2809 2.5 mg QD

VK2809 2.5 mg QD

VK2809 5 mg QOD

VK2809 5 mg每日一次

VK2809 10 mg QOD

VK2809 10 mg每日一次

Patients with F2 Fibrosis

F2纤维化患者

-7.8 %

-7.8 %

-11.0 %

-11.0 %

-44.9%***

-44.9%***

-38.0%**

-38.0%**

-49.2%***

-49.2%***

Patients with F3 Fibrosis

F3纤维化患者

-1.6 %

-1.6 %

-21.1 %

-21.1 %

-40.1%***

-40.1%***

-39.0%***

-39.0%***

-57.5%***

-57.5%***

Mean relative % change in liver fat at 12 weeks among patients with F2 and F3 fibrosis. **p<0.01 vs. placebo, ***p<0.001 vs. placebo.

F2和F3纤维化患者12周时肝脏脂肪的平均相对%变化**与安慰剂相比，＃p<0.01，与安慰剂相比，***p<0.001。

'We are pleased to see that the impressive efficacy demonstrated by VK2809 for the VOYAGE study's primary endpoint remains consistent across the study's key patient subpopulations.  Neither the presence of type 2 diabetes nor the presence of F2 or F3 fibrosis meaningfully impacted VK2809's efficacy at reducing liver fat.

“我们很高兴地看到VK2809对VOYAGE研究的主要终点所显示的令人印象深刻的疗效在整个研究的关键患者亚群中保持一致。2型糖尿病的存在以及F2或F3纤维化的存在均未显着影响VK2809降低肝脏脂肪的功效。

As steatosis and lipotoxicity are believed to be underlying drivers in NASH, these data suggest benefits across important disease subgroups,' stated Brian Lian, Ph.D., chief executive officer of Viking. 'We look forward to reporting 52-week biopsy data from VOYAGE in the first half of 2024.'.

Viking首席执行官Brian Lian博士说，由于脂肪变性和脂毒性被认为是NASH的潜在驱动因素，这些数据表明重要疾病亚组都有益处我们期待在2024年上半年报告航程52周的活检数据。

Safety and Tolerability

安全性和耐受性

As previously reported, data from the VOYAGE study also confirmed VK2809's encouraging safety and tolerability profile.  After 12 weeks, 94% of treatment related adverse events among patients receiving VK2809 were reported as mild or moderate. As in prior studies, VK2809 demonstrated excellent gastrointestinal tolerability, with rates of nausea, diarrhea, stool frequency, and vomiting similar among VK2809-treated patients compared to placebo. .

如先前报道，航程研究的数据也证实了VK2809令人鼓舞的安全性和耐受性。12周后，接受VK2809的患者中94%的治疗相关不良事件报告为轻度或中度。与以前的研究一样，VK2809表现出优异的胃肠道耐受性，与安慰剂相比，VK2809治疗的患者的恶心，腹泻，大便次数和呕吐发生率相似。 .

Study Design

学习规划

The VOYAGE study is a randomized, double-blind, placebo-controlled, multicenter, international trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis.  Enrollment included patients with at least 8% liver fat content as measured by MRI-PDFF, as well as F2 and F3 fibrosis.

VOYAGE研究是一项随机，双盲，安慰剂对照，多中心的国际试验，旨在评估VK2809在活检证实的NASH和纤维化患者中的疗效，安全性和耐受性。入组包括通过MRI-PDFF测量的肝脏脂肪含量至少为8%的患者，以及F2和F3纤维化。

The study allowed for up to 25% of enrolled patients to have F1 fibrosis provided that they also possess at least one additional risk factor, such as diabetes, obesity or hypertension, among others. The primary endpoint of the study evaluated the change in liver fat content from baseline to Week 12 in patients treated with VK2809 as compared to patients receiving placebo.

该研究允许高达25%的登记患者患有F1纤维化，条件是他们还具有至少一种额外的风险因素，例如糖尿病，肥胖或高血压等。该研究的主要终点评估了与接受安慰剂的患者相比，用VK2809治疗的患者从基线到第12周的肝脏脂肪含量的变化。

Secondary objectives include the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment..

次要目标包括评估治疗52周后通过肝活检评估的组织学变化。。

About VK2809

关于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 compound is currently being evaluated in a Phase 2b clinical trial in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis.

VK2809是甲状腺激素β受体（TRβ）的口服，组织和受体亚型选择性激动剂，对肝组织以及β受体亚型具有选择性，表明在一系列脂质疾病中具有广阔的治疗潜力。该化合物目前正在2b期临床试验中对活检证实的非酒精性脂肪性肝炎（NASH）和纤维化患者进行评估。

VK2809 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在2a期研究中成功实现了主要和次要终点，用于治疗LDL-C升高和非酒精性脂肪性肝病（NAFLD）患者。据信肝组织中甲状腺激素β受体的选择性激活通过多种机制有利地影响胆固醇和脂蛋白水平，包括增加与脂质代谢和清除相关的基因的表达。  .

About Viking Therapeutics, Inc.

关于维京治疗公司。

Viking Therapeutics 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 Therapeutics是一家临床阶段的生物制药公司，专注于开发用于治疗代谢和内分泌紊乱的新型一流或一流疗法，目前有三种化合物正在临床试验中。维京的研究和开发活动利用其在新陈代谢方面的专业知识开发旨在改善患者生活的创新疗法。

The company's clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, which is currently being evaluated in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis.

该公司的临床计划包括VK2809，一种用于治疗脂质和代谢紊乱的新型口服小分子选择性甲状腺激素受体β激动剂，目前正在2b期研究中评估用于治疗活检证实的非酒精性脂肪性肝炎（NASH）和纤维化。

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 is also developing 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.

在用于治疗非酒精性脂肪性肝病（NAFLD）和升高的LDL-C的2a期试验中，与接受安慰剂的患者相比，接受VK2809的患者表现出LDL-C和肝脏脂肪含量的统计学显着降低。该公司还开发VK2735，一种胰高血糖素样肽1（GLP-1）和葡萄糖依赖性促胰岛素多肽（GIP）受体的新型双重激动剂，用于潜在治疗各种代谢紊乱。

Data from a Phase 1 trial evaluating VK2735 (dosed subcutaneously) for metabolic disorders demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. The company also recently initiated a Phase 1 study to evaluate an oral formulation of VK2735. In the rare disease space, the company 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). VK0214 is currently being evaluated in a Phase 1b clinical trial .

来自评估VK2735（皮下给药）代谢紊乱的1期试验的数据显示出令人鼓舞的安全性和耐受性特征以及临床益处的积极迹象。该公司最近还启动了一项1期研究，以评估VK2735的口服制剂。在罕见疾病领域，该公司正在开发VK0214，一种新型，口服，小分子选择性甲状腺激素受体β激动剂，用于潜在治疗X连锁肾上腺脑白质营养不良（X-ALD）。VK0214目前正在1b期临床试验中进行评估。

For more information about Viking Therapeutics, please visit www.vikingtherapeutics.com.

有关Viking Therapeutics的更多信息，请访问www.vikingtherapeutics.com。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its clinical and preclinical development programs. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance.

根据1995年“美国私人证券诉讼改革法案”的安全港规定，本新闻稿包含有关Viking Therapeutics，Inc.的前瞻性声明，包括有关Viking对其临床和临床前开发计划的期望的声明。前瞻性陈述存在风险和不确定性，可能导致实际结果出现重大不利差异，报告结果不应视为未来业绩的指标。

These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK2735, VK0214, VK2809, and the company's other incretin receptor agonists; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission, including Viking's Annual Report on Form 10-K for the year ended December 31, 2022, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings.

这些风险和不确定性包括但不限于：与Viking产品候选开发活动和临床试验（包括VK2735，VK0214，VK2809和公司其他肠促胰岛素受体激动剂）的成功，成本和时间相关的风险；先前的临床和临床前结果可能无法复制的风险；有关监管要求的风险；以及向证券交易委员会提交的Viking最新定期报告中描述的其他风险，包括截至2022年12月31日止年的Viking 10-K年度报告以及随后的10-Q年度报告，包括这些文件中规定的风险因素。

These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements except as required by law..

这些前瞻性声明仅在本协议签署之日起生效。除法律要求外，Viking不承担更新这些前瞻性声明的任何义务。。

SOURCE Viking Therapeutics, Inc

来源维京治疗公司