VK-2735

13-Week Study Evaluating the Safety and Efficacy of Oral VK2735 Dosed Once Daily Results Expected in 2H25 SAN DIEGO, March 26, 2025 /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 completion of subject enrollment in its Phase 2 clinical trial of the oral tablet formulation of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. VK2375 is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity. Viking expects to report data from the study in the second half of 2025. The Phase 2 VENTURE-Oral Dosing Trial is a randomized, double-blind, placebo-controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. The trial enrolled approximately 280 adults who are obese (BMI ≥30 kg/m2), or adults who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition. Enrolled patients have been evenly randomized to one of six dosing arms or placebo. The primary endpoint of the study is the percent change in body weight from baseline after 13 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures. "As with our previous Phase 2 study of subcutaneous VK2735, interest in participating in the Phase 2 VENTURE-Oral study was high and drove an efficient rate of enrollment," said Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. "Despite its larger size, VENTURE-Oral was rapidly enrolled, highlighting the continued enthusiasm for new obesity therapeutics such as VK2735. We look forward to reporting data from this trial in the second half of 2025." Viking previously reported positive results from a 28-day Phase 1 multiple ascending dose (MAD) clinical trial of the tablet formulation of VK2735 in healthy volunteers with a BMI ≥30. Cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to 8.2%. Persistent weight loss effects were observed at follow-up visits through Day 57, ranging up to 8.3% from baseline, four weeks after the last dose of VK2735 was administered. An exploratory assessment of the proportion of subjects achieving at least 5% weight loss after 28 days demonstrated that up to 100% of VK2735-treated subjects achieved ≥5% weight loss, compared with 0% for placebo. Based on a preliminary evaluation of weight loss trajectories at multiple dose levels, the company believes that continued treatment beyond 28 days may provide further reductions in body weight. In the MAD trial, oral VK2735 also demonstrated encouraging safety and tolerability through 28 days of once-daily dosing at doses up to and including 100 mg. The majority (99%) of observed treatment emergent adverse events were mild or moderate, with the majority (90%) reported as mild. Similarly, all observed gastrointestinal adverse events were reported as mild or moderate, with the majority (84%) reported as mild. Concurrent with the development of oral VK2735, Viking is also advancing a subcutaneous formulation of VK2735 through clinical development. The company previously announced positive data from the Phase 2 VENTURE study of subcutaneous VK2735, with the trial successfully achieving its primary and all secondary endpoints. Patients receiving VK2735 demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7%. Statistically significant differences compared to placebo were observed for all doses starting at Week 1 and were maintained throughout the course of the study. Weight loss in all treated cohorts appeared to be progressive through 13 weeks and did not show evidence of plateauing. VK2735 also demonstrated encouraging safety and tolerability in the VENTURE study, with the majority of observed adverse events being reported as mild or moderate. The company plans to initiate Phase 3 development with the subcutaneous formulation of VK2735 in the first half of 2025. About GLP-1 and Dual GLP-1/GIP Agonists 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®. 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®. About 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 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 2 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) 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. For more information about Viking Therapeutics, please visit . Forward-Looking Statements 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, 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, 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. SOURCE Viking Therapeutics, Inc. 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导语：在诺和诺德与礼来凭借注射剂掀起全球减肥风暴后，GLP-1 赛道即将迎来口服剂型的颠覆性竞争。随着礼来 5.5 亿美元的产能布局与多家新锐药企的加速入场，一场围绕生产能力的行业大考正在上演。当每日一片的便捷性遭遇全球数亿患者的需求激增，CMO（合同制造组织）能否成为这场产能革命的关键变量？一、从 “一针难求” 到 “口服革命”：GLP-1 赛道的产能突围战 2023 年，诺和诺德的 Wegovy 与礼来的 Zepbound 因供应短缺引发全球抢购潮，迫使 FDA 将其列入短缺清单。如今，两家巨头通过百亿级投资（如诺和诺德 165 亿美元收购 Catalent）逐步缓解注射剂产能压力，但新的挑战已悄然来临 —— 口服 GLP-1 药物的量产竞赛正式拉开帷幕。 礼来先发制人：斥资 5.5 亿美元提前生产 orforglipron，计划 2025 年启动 III 期临床，目标覆盖糖尿病与肥胖症市场。 新锐药企抢滩：Viking Therapeutics 与 CordenPharma 签约生产 10 亿片 VK2735 片剂，Metsera 在 I 期临床阶段即锁定产能，凸显行业对口服剂型的战略押注。二、口服剂型的 “生产优势” 与 “规模陷阱” 相较于注射剂的复杂工艺（需无菌环境与专用设备），口服 GLP-1 药物采用标准固体剂量生产线，理论上可实现规模化生产。然而，每日一次的用药频率将导致剂量需求暴增： 产量鸿沟：以 Zepbound 为例，每周一针对应年剂量 52 支；若转为口服，年剂量将达 365 片，产能需求激增 7 倍。 技术瓶颈：口服生物利用度不足 1% 是核心障碍，需通过脂质制剂、离子对技术提升吸收效率，CordenPharma 等 CMO 正在攻关相关工艺。三、CMO 行业的 “产能军备竞赛” 全球仅 46% 的 CMO 具备肽类药物端到端生产能力，但口服剂型的崛起正重塑行业格局： 产能扩张潮：CordenPharma、Lonza 等龙头加速扩建固体剂量生产线，利用现有设施快速切换产能。 技术差异化：部分 CMO 开发缓释技术，将每日一次用药延长至每周一次，如诺和诺德的 Rybelsus（已获批糖尿病适应症）。 市场分层：大型 CMO 主攻巨头订单，中小型 CMO 则聚焦新锐药企，形成 “高定制化 + 规模化” 的双轨模式。四、行业博弈：谁将主导口服 GLP-1 的 “产能密码” 巨头垄断与新锐破局：诺和诺德与礼来通过专利壁垒与产能布局巩固优势，但口服剂型的低准入门槛可能吸引更多玩家，如辉瑞、默沙东已启动相关研发。 供应链风险：原料药（如司美格鲁肽）的全球供应链稳定性仍是隐忧，地缘政治冲突或导致关键原料短缺。 患者与支付方的选择：口服剂型的便捷性可能推动患者从注射剂转向口服，但需证明其长期疗效与安全性，否则医保支付意愿可能受限。五、专家观点：产能决定市场话语权 “口服 GLP-1 的生产本质是‘规模经济’与‘技术创新’的双重博弈。” 投行 William Blair 合伙人 Matt Phipps 指出，“CMO 的响应速度将成为药企能否抓住市场窗口的关键。” 而 CordenPharma 全球肽类平台负责人 Mimoun Ayoub 则表示：“我们已预留 30% 的产能弹性，以应对可能爆发的需求。但真正的挑战在于如何在保证质量的前提下，将片剂日产量从 100 万片提升至 1 亿片。”六、未来展望：产能革命重塑行业版图 随着礼来、诺和诺德的口服候选药物陆续进入 III 期，全球 GLP-1 市场将从 “技术驱动” 转向 “产能驱动”。若 CMO 能突破产能瓶颈，口服剂型或在 5 年内占据市场份额的 60%，催生一个千亿级的新市场。但正如行业分析师所言：“这不是一场短跑，而是马拉松 —— 只有具备全链条整合能力的企业，才能笑到最后。” 七、结语当 GLP-1 从 “奢侈品” 变为 “日用品”，生产能力已取代研发成为行业的核心竞争力。这场没有硝烟的产能战争，不仅关乎药企的市场份额，更将重塑全球肥胖与糖尿病治疗的生态格局。而 CMO，这个曾隐身幕后的角色，或将成为改写历史的关键力量。 参考来源：https://www.biospace.com/business/glp-1-injectables-will-soon-be-joined-by-orals-is-the-industry-ready-to-scale 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！ 请注明：姓名+研究方向！ 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。