Company's Receptor Co-Agonists Demonstrate Potent Body Weight Reductions, Decreased Food Intake and Improved Metabolic Profile in Healthy Rats and Diet-Induced Obese Mice

该公司的受体共同激动剂在健康大鼠和饮食诱导的肥胖小鼠中显示出有效的体重减轻，食物摄入减少和代谢状况改善

SAN DIEGO, June 24, 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 the presentation of preclinical data from a series of internally developed dual agonists of the amylin and calcitonin receptors at the 84th Scientific Sessions of the American Diabetes Association.  The presentation highlights the effects of treatment on body weight, food intake and metabolic profile in healthy rats and diet-induced obese (DIO) mice as compared to control cohorts treated with vehicle or the dual amylin and calcitonin receptor agonist cagrilintide.

圣地亚哥，2024年6月24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，今天宣布在美国糖尿病协会第84届科学会议上展示一系列内部开发的胰淀素和降钙素受体双重激动剂的临床前数据。该演讲强调了与用载体或双胰淀素和降钙素受体激动剂cagrilintide治疗的对照组相比，治疗对健康大鼠和饮食诱导的肥胖（DIO）小鼠的体重，食物摄入和代谢特征的影响。

The studies were summarized in a poster presentation at the annual scientific conference of the American Diabetes Association, being held June 21-24, 2024, in Orlando, Florida. .

2024年6月21日至24日，在佛罗里达州奥兰多举行的美国糖尿病协会年度科学会议上，这些研究总结在海报上。

The study results demonstrate that Viking's series of dual amylin and calcitonin receptor agonists (DACRAs) reduced food intake in lean rats in the period from 0 – 72 hours following a single subcutaneous dosing.  At 72 hours following a single subcutaneous dose, Viking's novel compounds resulted in up to 8% body weight reductions compared to vehicle-treated animals..

研究结果表明，Viking的一系列双胰淀素和降钙素受体激动剂（DACRAs）在单次皮下给药后0-72小时内减少了瘦鼠的食物摄入量。在单次皮下给药后72小时，与媒介物处理的动物相比，Viking的新型化合物导致高达8%的体重减轻。。

In a DIO mouse model, treatment with Viking's series of co-agonists for 24 days resulted in body weight reductions that were comparable to those achieved in cagrilintide-treated animals.  Additionally, improvements in key metabolic markers, including blood glucose levels, were observed in DIO mice treated with the company's compounds for the 24-day time period..

在DIO小鼠模型中，用Viking系列共激动剂治疗24天导致体重减轻，与cagrilintide治疗的动物相当。此外，在用该公司化合物治疗24天的DIO小鼠中，观察到关键代谢标志物（包括血糖水平）的改善。。

Highlights from poster 2024-LB-5842: Novel Amylin and Calcitonin Receptor Co-Agonists Reduce Food Intake and Body Weight in Rodents.

海报2024-LB-5842的亮点：新型胰淀素和降钙素受体共同激动剂可减少啮齿动物的食物摄入量和体重。

Viking DACRAs demonstrated EC50 values ranging from low nM to micromolar on the human amylin 3 receptor and a similar range of potencies on the human calcitonin receptor.

维京达卡对人胰淀素3受体的EC50值范围从低nM到微摩尔，对人降钙素受体的效力范围相似。

Treatment with single doses of Viking DACRAs resulted in up to 8% mean reductions in body weight in lean rats after 72 hours.

用单剂量的维京达卡治疗72小时后，瘦大鼠的体重平均减少了8%。

Treatment of DIO mice for 24 days with Viking DACRA compounds demonstrated up to 10% weight loss from baseline (p<0.05 vs. baseline).

用Viking DACRA化合物治疗DIO小鼠24天，与基线相比，体重减轻了10%（与基线相比，p＜0.05）。

Viking DACRA compounds demonstrated up to 24% reductions in blood glucose in DIO mice after 24 days (p<0.05 vs. baseline and cagrilintide control).

Viking DACRA化合物在24天后显示DIO小鼠的血糖降低高达24%（与基线和cagrilintide对照相比，p<0.05）。

The results of these and other preclinical studies provide the rationale for Viking's continued advancement of its internal dual amylin and calcitonin receptor agonist development program.

这些和其他临床前研究的结果为Viking继续推进其内部双胰淀素和降钙素受体激动剂开发计划提供了理论基础。

'The amylin receptor plays an important role in food intake and metabolic control, making it an attractive target for therapeutic intervention in obesity,' said Brian Lian, Ph.D., chief executive officer of Viking.  'These data demonstrate the potent activity of a series of novel, internally developed, amylin and calcitonin dual agonists and represent an exciting expansion of our pipeline in obesity and metabolic diseases.

。“这些数据证明了一系列新型的，内部开发的，胰淀素和降钙素双重激动剂的有效活性，代表了我们在肥胖和代谢疾病中令人兴奋的管道扩张。

This program provides Viking with additional opportunities to develop novel, differentiated therapies for obesity with potentially best-in-class profiles.'.

该计划为维京人提供了额外的机会，以开发新型的，有区别的肥胖治疗方法，并具有潜在的同类最佳概况。”。

About Amylin and Dual Amylin/Calcitonin Agonists

关于胰淀素和双胰淀素/降钙素激动剂

Amylin has important effects on glucose management, glucagon production, gastric emptying time and satiety.  Amylin analogs have been shown to significantly reduce body weight and dosage of insulin.  Dual amylin and calcitonin receptor agonists are the most potent amylin receptor agonists.  Cagrilintide is a dual amylin/calcitonin receptor agonist that is currently in clinical development..

胰淀素对葡萄糖管理，胰高血糖素产生，胃排空时间和饱腹感有重要影响。胰淀素类似物已被证明可显着降低体重和胰岛素剂量。双胰淀素和降钙素受体激动剂是最有效的胰淀素受体激动剂。卡格列奈是一种双胰淀素/降钙素受体激动剂，目前正在临床开发中。。

About Viking Therapeutics, Inc.

关于Viking Therapeutics，Inc。

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 VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders.

Viking Therapeutics，Inc.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。Viking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。

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) 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. Viking 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.

该化合物在最近完成的用于治疗活检证实的非酒精性脂肪性肝炎（NASH）和纤维化的2b期研究中成功实现了主要和次要终点。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。Viking还正在开发VK2735，它是胰高血糖素样肽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，可用于各种代谢紊乱的潜在治疗。

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. The company is also evaluating an oral formulation of VK2735 in a Phase 1 trial. 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). VK0214 is curr.

评估VK2735（皮下给药）治疗代谢紊乱的第一阶段和第二阶段试验的数据显示，其安全性和耐受性令人鼓舞，并且有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，维京正在开发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为货币。

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, anticipated timing for reporting clinical data and cash resources.  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, the company's incretin receptor agonists, and its amylin and calcitonin 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, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings.  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..

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Viking Therapeutics，Inc.的前瞻性声明，包括关于Viking对其临床和临床前开发计划的期望，报告临床数据的预期时间和现金资源的声明。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，该公司的肠降血糖素受体激动剂及其胰淀素和降钙素受体激动剂）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；以及维京公司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，包括维京公司截至2023年12月31日的10-K表年度报告和随后的10-Q表季度报告，包括这些文件中规定的风险因素。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。。

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SOURCE Viking Therapeutics, Inc.

来源Viking Therapeutics，Inc。

Company Codes: NASDAQ-SMALL:VKTX

公司代码：NASDAQ-SMALL：VKTX