Viking Therapeutics宣布双GLP-1/GIP受体激动剂VK2735口服片剂1期临床试验结果-动脉网

Viking Therapeutics Announces Results from Phase 1 Clinical Trial of Oral Tablet Formulation of Dual GLP-1/GIP Receptor Agonist VK2735

BioSpace 等信源发布 2024-03-26 19:38



可切换为仅中文







Up to 3.3% Placebo-Adjusted Mean Weight Loss (5.3% from Baseline) Observed After 28 Days

28天后观察到高达3.3%的安慰剂调整后的平均体重减轻（比基线降低5.3%）

VK2735 Shown to be Safe and Well-Tolerated in 28-Day Study with Low Rates of GI-Related Adverse Events

VK2735在28天的研究中显示安全且耐受性良好，胃肠道相关不良事件发生率低

Phase 2 Trial in Obesity Planned for 2H24

计划在2H24进行肥胖的2期试验

Conference Call Scheduled for 8:00 a.m. ET Today

电话会议定于美国东部时间今天上午8:00

SAN DIEGO, March 26, 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 positive results from the company's Phase 1 multiple ascending dose (MAD) clinical trial of an oral tablet formulation of VK2735, a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, in development for the potential treatment of metabolic disorders such as obesity.

圣地亚哥，2024年3月26日/PRNewswire/--Viking Therapeutics，Inc.（“Viking”）（纳斯达克：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，今天宣布该公司的口服片剂制剂VK2735（胰高血糖素样肽1（GLP-1）和葡萄糖依赖性促胰岛素多肽（GIP）受体的双重激动剂）的第一阶段多剂量递增（MAD）临床试验取得了积极成果，该制剂正在开发用于治疗肥胖等代谢紊乱的潜在方法。

Based on these Phase 1 results, the company plans to initiate a Phase 2 trial with the oral formulation of VK2735 in obesity later this year..

根据这些第一阶段的结果，该公司计划在今年晚些时候启动一项第二阶段试验，使用VK2735口服制剂治疗肥胖症。。

Highlights from the study results include:

研究结果的亮点包括：

Body Weight Reductions

体重减轻

The 28-day MAD study results highlight positive signs of clinical activity following treatment with oral VK2735. Cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to 5.3%. Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 3.3%.

28天的MAD研究结果突出了口服VK2735治疗后临床活动的积极迹象。接受VK2735的队列显示，与基线相比，平均体重呈剂量依赖性降低，范围高达5.3%。接受VK2735的队列也显示出相对于安慰剂的平均体重减轻，范围高达3.3%。

For doses ≥10 mg, placebo-adjusted reductions in mean body weight were maintained or improved at Day 34, six days after the last dose of VK2735 was administered, ranging up to 3.6% relative to placebo. An exploratory assessment of the proportion of subjects achieving at least 5% weight loss after 28 days demonstrated that up to 57% of VK2735-treated subjects achieved ≥5% weight loss, compared with 0% for placebo.

对于剂量≥10 mg的患者，在服用最后一剂VK2735后6天，在第34天维持或改善了安慰剂调整后的平均体重下降，相对于安慰剂，下降幅度高达3.6%。对28天后体重减轻至少5%的受试者比例的探索性评估表明，高达57%的VK2735治疗受试者体重减轻≥5%，而安慰剂组为0%。

Based on a preliminary evaluation of weight loss trajectory, the company believes that treatment duration beyond 28 days may provide further reductions in body weight..

根据对减肥轨迹的初步评估，该公司认为超过28天的治疗时间可能会进一步减轻体重。。

'These Phase 1 results highlight VK2735's promising early weight loss and tolerability profile when dosed as an oral tablet,' said Brian Lian, Ph.D., chief executive officer of Viking. 'We believe these data indicate that longer treatment duration, at potentially higher doses, may result in additional weight loss.

Viking首席执行官布莱恩·连（BrianLian）博士说，这些第一阶段的结果突显了VK2735口服片剂时有希望的早期减肥和耐受性我们相信这些数据表明，更长的治疗时间，可能更高的剂量，可能会导致额外的体重减轻。

We are particularly pleased with the initial safety and tolerability data, which suggest a differentiated profile with minimal gastrointestinal-related side effects. We believe that an oral agent with good tolerability could represent an attractive potential treatment option for patients with obesity.

我们对最初的安全性和耐受性数据特别满意，这些数据表明，胃肠道相关副作用最小的情况有所不同。我们认为，具有良好耐受性的口服药物可能是肥胖患者的一种有吸引力的潜在治疗选择。

We look forward to exploring longer treatment windows and potentially higher doses in an upcoming Phase 2 trial.'.

我们期待在即将到来的第二阶段试验中探索更长的治疗窗口和可能更高的剂量。”。

Observed Change in Body Weight Following 28 Days of Daily Dosing with Oral VK2735

每日口服VK2735 28天后观察到的体重变化

Multiple Ascending

多次升序

Dose Level1,2

剂量水平1,2

Placebo

安慰剂

(n=10)

（n=10）

VK2735

2.5 mg

2.5毫克

(n=8)

（n=8）

VK2735

5 mg

5毫克

(n=6)

（n=6）

VK2735

10 mg

10毫克

(n=6)

（n=6）

VK2735

20 mg

20毫克

(n=8)

（n=8）

VK2735

40 mg

40毫克

(n=7)

（n=7）

Mean baseline body

平均基线体

weight3

权重3

94.6 kg

94.6千克

102.3 kg

102.3千克

95.3 kg

95.3千克

97.1 kg

97.1千克

111.2 kg

111.2千克

90.0 kg

90.0千克

Mean change from

平均变化自

baseline body

基线主体

weight4,5

权重4,5

-2.0 kg

-2.0千克

-0.3 kg

-0.3千克

-0.8 kg

-0.8千克

-1.3 kg

-1.3千克

-3.3 kg

-3.3千克

-4.9 kg

-4.9千克

Mean percent change

平均百分比变化

from baseline4,5

从基线4,5

-2.1 %

-0.3 %

-0.9 %

-1.1 %

-3.2 %

-5.3 %

Placebo-adjusted

安慰剂调整

mean percent change

平均百分比变化

from baseline4,5

从基线4,5

-（笑声）

1.8 %

1.2 %

1.0 %

-1.1 %

-3.3 %

p-value vs. placebo5

p值与安慰剂5

-（笑声）

0.23

0.0006

Percent reporting

报告百分比

≥5% weight loss

体重减轻≥5%

0 %

25 %

57 %

p-value vs. placebo6

p值与安慰剂6

-（笑声）

0.18

0.015

Notes: 1) Population includes all randomized subjects who received at least one dose of study drug and had at least one planned post-baseline body weight assessment. 2) Patients treated with VK2735 were titrated to final doses as indicated: 2.5 mg cohort = 2.5 daily x 4 weeks; 5 mg cohort = 2.5 mg daily x 1 wk, 5 mg daily x 3 wks; 10 mg cohort = 5 mg daily x 1 wk, 10 mg daily x 3 wks; 20 mg cohort = 15 mg daily x 1 wk, 20 mg daily x 3 wks; 40 mg cohort = 20 mg daily x 1 wk, 40 mg daily x 3 wks.

注：1）人群包括所有接受至少一剂研究药物且至少有一次计划的基线后体重评估的随机受试者。2）如所示，用VK2735治疗的患者滴定至最终剂量：2.5 mg队列=每天2.5 x 4周；5毫克队列=每天2.5毫克x 1周，每天5毫克x 3周；10毫克队列=每天5毫克x 1周，每天10毫克x 3周；20毫克队列=每天15毫克x 1周，每天20毫克x 3周；40毫克队列=每天20毫克x 1周，每天40毫克x 3周。

3) All subjects enrolled were required to have baseline BMI ≥30 kg/m2. 4) Least squares mean. 5) Two-sided t test using mixed model for repeated measures. 6) Fisher's exact test..

3）所有入选的受试者都需要基线BMI≥30 kg/m2。4）最小二乘平均值。5）使用混合模型进行重复测量的双侧t检验。6）费舍尔精确检验。。

Safety and Tolerability

安全性和耐受性

Oral VK2735 demonstrated encouraging safety and tolerability following 28 days of once-daily dosing. Among subjects receiving VK2735, all treatment emergent adverse events (TEAEs) reported to date have been mild or moderate, with the majority (76%) reported as mild. Similarly, all observed gastrointestinal (GI) adverse events have been reported as mild or moderate, with the majority (79%) reported as mild.

口服VK2735在每日一次给药28天后表现出令人鼓舞的安全性和耐受性。在接受VK2735治疗的受试者中，迄今为止报告的所有治疗紧急不良事件（TEAE）均为轻度或中度，其中大多数（76%）报告为轻度。同样，所有观察到的胃肠道（GI）不良事件均报告为轻度或中度，其中大多数（79%）报告为轻度。

Mild nausea was reported in five (14%) VK2735-treated subjects. Vomiting was not reported among any VK2735-treated subjects. Diarrhea was reported in one subject (3%) receiving VK2735 compared with two subjects (20%) receiving placebo. Overall, no clinically meaningful differences were reported for GI-related adverse events among subjects treated with VK2735 compared with placebo.

据报道，五名（14%）接受VK2735治疗的受试者出现轻度恶心。在任何接受VK2735治疗的受试者中均未报告呕吐。据报道，接受VK2735治疗的一名受试者（3%）出现腹泻，而接受安慰剂治疗的两名受试者（20%）出现腹泻。总体而言，与安慰剂相比，用VK2735治疗的受试者中胃肠道相关不良事件没有临床意义上的差异。

In addition, no serious adverse events (SAEs) have been reported to date..

此外，迄今为止，尚未报告严重不良事件（SAE）。。

Common GI-Related Adverse Events Following 28 Days of Daily Dosing with Oral VK2735

每日口服VK2735 28天后常见的胃肠道相关不良事件

Common AEs,

常见不良事件，

No. of Subjects

受试者数量

reporting, (%)

报告，（%）

Placebo

安慰剂

(n=10)

（n=10）

VK2735

2.5 mg

2.5毫克

(n=8)

（n=8）

VK2735

5 mg

5毫克

(n=7)

（n=7）

VK2735

10 mg

10毫克

(n=6)

（n=6）

VK2735

20 mg

20毫克

(n=8)

（n=8）

VK2735

40 mg

40毫克

(n=8)

（n=8）

VK2735

Combined

合并

(n=37)

（n=37）

Nausea

恶心

Mild

温和的

Moderate

中等

Severe

严重

0 (0%)

1 (14%)

0 (0%)

2 (25%)

0 (0%)

2 (25%)

0 (0%)

5 (14%)

0 (0%)

Vomiting

呕吐

0 (0 %)

Diarrhea

腹泻

2 (20 %)

0 (0 %)

1 (13 %)

0 (0 %)

1 (3 %)

Constipation

便秘

2 (20 %)

0 (0 %)

Notes: Safety population, includes all randomized subjects who received at least one dose of study drug or placebo.

注意：安全人群，包括接受至少一剂研究药物或安慰剂的所有随机受试者。

Based on the encouraging weight loss, as well as the safety and tolerability results to date, the company has elected to continue further dose escalation in this study. Viking also plans to initiate a Phase 2 trial of oral VK2735 in patients with obesity in the second half of 2024.

基于令人鼓舞的体重减轻以及迄今为止的安全性和耐受性结果，该公司选择在本研究中继续进一步增加剂量。Viking还计划在2024年下半年启动肥胖患者口服VK2735的2期试验。

The Phase 1 MAD study of oral VK2735 is an extension of the company's Phase 1 single ascending dose (SAD)/MAD trial of VK2735 administered subcutaneously. The oral portion of the trial is a randomized, double-blind, placebo-controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter squared.

口服VK2735的第一阶段MAD研究是该公司皮下注射VK2735的第一阶段单次递增剂量（SAD）/MAD试验的延伸。该试验的口服部分是一项针对健康成年人的随机、双盲、安慰剂对照研究，最低体重指数为每平方米30公斤。

The primary objective of the study was to evaluate the safety and tolerability of VK2735 administered as an oral tablet once daily for 28 days. Exploratory pharmacodynamic measures included assessments of changes in body weight and other metrics..

该研究的主要目的是评估VK2735作为口服片剂每天一次，持续28天的安全性和耐受性。探索性药效学测量包括评估体重变化和其他指标。。

Conference Call

电话会议

Management will host a conference call to discuss results from the company's Phase 1 trial of an oral formulation of VK2735 today at 8:00 am Eastern. To participate in the conference call, please dial (844) 850-0543 from the U.S. or (412) 317-5199 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until April 2, 2024, by dialing (877) 344-7529 from the U.S.

管理层将于今天上午8:00（东部时间）召开电话会议，讨论该公司口服VK2735制剂的第一阶段试验结果。要参加电话会议，请从美国拨打（844）850-0543或从美国境外拨打（412）317-5199。此外，通话结束后，可以从美国拨打（877）344-7529，在2024年4月2日之前进行电话重播。

or (412) 317-0088 from outside the U.S. and entering conference ID #6296711. Those interested in listening to the conference call live via the internet may do so by visiting the Webcasts page of Viking's website at http://ir.vikingtherapeutics.com/webcasts. An archive of the webcast will also be available on the Webcasts page of Viking's website for 30 days..

或（412）317-0088来自美国境外，并输入会议ID#6296711。有兴趣通过互联网收听现场电话会议的人可以访问维京人网站的网络广播页面http://ir.vikingtherapeutics.com/webcasts.维京人网站的网络广播页面上也将提供为期30天的网络广播档案。。

About GLP-1 and Dual GLP-1/GIP Agonists

关于GLP-1和双重GLP-1/GIP激动剂

Activation of the glucagon-like peptide 1 (GLP-1) receptor has been shown to decrease glucose, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both. Semaglutide is a GLP-1 receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Ozempic®, Rybelsus®, and Wegovy®.

胰高血糖素样肽1（GLP-1）受体的激活已被证明可降低2型糖尿病，肥胖症或两者患者的血糖，降低食欲，降低体重，并改善胰岛素敏感性。Semaglutide是一种GLP-1受体激动剂，已获得美国食品和药物管理局的批准，目前以各种剂量强度和形式销售，如Ozempic®，Rybelsus®和Wegovy®。

More recently, research efforts have explored the potential co-activation of the glucose-dependent insulinotropic peptide (GIP) receptor as a means of enhancing the therapeutic benefits of GLP-1 receptor activation. Tirzepatide is a dual GLP-1/GIP receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Mounjaro® and Zepbound®..

最近，研究工作已经探索了葡萄糖依赖性促胰岛素肽（GIP）受体的潜在共激活，作为增强GLP-1受体激活的治疗益处的手段。Tirzepatide是一种双重GLP-1/GIP受体激动剂，已获得美国食品和药物管理局的批准，目前以各种剂量和形式销售，如Mounjaro®和Zepbound®。。

About Viking Therapeutics, Inc.

关于Viking Therapeutics，Inc。

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疾病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。Viking的研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.

该公司的临床项目包括VK2809，一种新型的口服小分子选择性甲状腺激素受体β激动剂，用于治疗脂质和代谢紊乱，目前正在进行2b期研究，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.

在一项治疗非酒精性脂肪性肝病（NAFLD）和LDL-C升高的2a期临床试验中，接受VK2809治疗的患者与接受安慰剂治疗的患者相比，LDL-C和肝脏脂肪含量在统计学上显着降低。该公司还在开发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 and a Phase 2 trial evaluating VK2735 (dosed subcutaneously) for obesity demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. The company is also evaluating an oral formulation of VK2735 in a Phase 1 trial. 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).

来自评估VK2735（皮下给药）治疗肥胖症的1期和2期试验的数据显示出令人鼓舞的安全性和耐受性以及临床获益的积极迹象。该公司还在一期试验中评估VK2735的口服制剂。在罕见疾病领域，该公司正在开发VK0214，这是一种新型的口服小分子选择性甲状腺激素受体β激动剂，可用于治疗X连锁肾上腺白质营养不良（X-ALD）。

VK0214 is currently being evaluated in a Phase 1b clinical trial in patients .

VK0214目前正在患者的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 activities, timelines and milestones, including the Company's plans for VK2735 and its prospects.

根据1995年《美国私人证券诉讼改革法案》的安全港条款，本新闻稿包含关于维京治疗公司的前瞻性声明，包括关于维京对其临床和临床前开发计划活动、时间表和里程碑的期望的声明，包括该公司对VK2735的计划及其前景。

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. 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, 2023 including the risk factors set forth in those filings.

前瞻性陈述受到风险和不确定性的影响，这些风险和不确定性可能导致实际结果产生重大不利差异，报告的结果不应被视为未来业绩的指标。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和公司其他肠降血糖素受体激动剂）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；与监管要求有关的风险；以及维京向美国证券交易委员会提交的最新定期报告中描述的其他风险，包括维京截至2023年12月31日的10-K表年度报告，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有效。维京不承担更新这些前瞻性声明的任何义务，除非法律要求。。

View original content to download multimedia:https://www.prnewswire.com/news-releases/viking-therapeutics-announces-results-from-phase-1-clinical-trial-of-oral-tablet-formulation-of-dual-glp-1gip-receptor-agonist-vk2735-302098869.html

查看原始内容以下载多媒体：https://www.prnewswire.com/news-releases/viking-therapeutics-announces-results-from-phase-1-clinical-trial-of-oral-tablet-formulation-of-dual-glp-1gip-receptor-agonist-vk2735-302098869.html

SOURCE Viking Therapeutics, Inc.

来源Viking Therapeutics，Inc。

Company Codes: NASDAQ-SMALL:VKTX

公司代码：NASDAQ-SMALL：VKTX

全球产业链接平台

重庆市渝北区金星科技大厦A区5楼512室

联系电话：023-67139735（重庆）

关于我们

联系我们

加入我们

意见反馈

产品服务