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代谢药物生物技术公司Kailera斥资4亿美元推出下一代减肥药物

Metabolic Meds Biotech Kailera Launches With $400M for Next-Generation Weight-Loss Drugs

MedCity News 等信源发布 2024-10-02 02:04

可切换为仅中文


Eli Lilly showed a drug that goes after two metabolic targets to treat obesity can successfully shed weight and become a revenue-generating heavyweight. Other companies aspire to improve on the Lilly drug’s approach and Kailera Therapeutics is the newest of them, backed by $400 million to support a pipeline of obesity drug candidates..

礼来公司(EliLilly)展示了一种针对两种代谢指标治疗肥胖症的药物,该药物可以成功减肥并成为创收的重量级人物。其他公司渴望改进礼来药物的方法,凯勒治疗公司是其中最新的一家公司,由4亿美元支持肥胖候选药物的管道。。

Kailera, which splits its operations between San Diego and Waltham, Massachusetts, is joining a growing field of companies developing drugs that mimic peptides in the body, binding to and activating receptors to spark metabolic effects. The company’s lead program goes after GLP-1 and GIP, targets addressed by Lilly’s blockbuster drug Zepbound, which won FDA approval for chronic weight management last November..

Kailera将其业务分为圣地亚哥和马萨诸塞州的沃尔瑟姆,它正在加入一个不断发展的领域,开发模仿体内肽的药物,结合并激活受体以激发代谢效应。该公司的主导计划是针对GLP-1和GIP,这是礼来的重磅炸弹药物Zepbound所针对的目标,该药物去年11月获得FDA批准用于慢性体重管理。。

Kailera’s portfolio of four metabolic disorder dugs comes from China-based Jiangsu Hengrui Pharmaceuticals. In May, Kailera licensed exclusive rights to develop those molecules globally, except for greater China where Hengrui retails rights. The most advanced program is KAI-9531, a once-weekly injectable dual agonist of the GLP-1 and GIP receptors.

凯勒的四个代谢紊乱DUG组合来自中国江苏恒瑞制药。5月,凯勒拉(Kailera)授权在全球范围内开发这些分子的专有权,但恒瑞零售权的大中华区除外。。

Under Hengrui, Kailera said this drug showed “compelling results” in obesity and type 2 diabetes from Phase 2 tests conducted in China..

凯勒拉表示,在恒瑞的领导下,这种药物在中国进行的2期试验中显示出对肥胖和2型糖尿病的“令人信服的结果”。。

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前进的道路是明确的:雇主必须像周六购物一样评估他们的健康计划。

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The Phase 2 test in obesity enrolled 249 participants randomly assigned one of four doses of the once-weekly injectable study drug or a placebo. The double-blind treatment period was 24 weeks. Hengrui presented Phase 2 results in obesity in June, during the American Diabetes Association Scientific Sessions meeting.

肥胖的第二阶段测试招募了249名参与者,随机分配了四剂每周一次的可注射研究药物或安慰剂中的一种。双盲治疗期为24周。恒瑞在6月的美国糖尿病协会科学会议上介绍了肥胖的第二阶段结果。

These results showed a dose-dependent increase in weight loss during the treatment period. At the 6 mg dose — the highest one tested — 53.1% of patients lost 15% or more of their body weight compared to baseline. Adverse events reported from the study included nausea, diarrhea, decreased appetite, and vomiting.

这些结果显示治疗期间体重减轻的剂量依赖性增加。在6毫克剂量(测试的最高剂量)下,与基线相比,53.1%的患者体重减轻了15%或更多。研究报告的不良事件包括恶心,腹泻,食欲下降和呕吐。

Gastrointestinal problems are consistent with other weight management drugs and Hengrui classified the side effects in its study as mild to moderate in severity..

胃肠道问题与其他减肥药物一致,恒瑞在其研究中将副作用分类为轻度至中度。。

It’s difficult to make cross-trial comparisons, but the results for the drug that is now Kailera’s lead program suggest it’s competitive with others targeting both GLP-1 and GIP. In Zepbound’s pivotal study, patients lost an average 18% of their body weight compared to those who received a placebo. In February, San Diego-based Viking Therapeutics reported Phase 2 data for its once-weekly injectable GLP-1 and GIP agonist, VK2735, showing an average 13.1% placebo-adjusted weight loss after 13 weeks of treatment.

很难进行交叉试验比较,但目前凯勒拉主导项目的药物结果表明,它与其他针对GLP-1和GIP的药物具有竞争力。在Zepbound的关键研究中,与服用安慰剂的患者相比,患者平均体重减轻了18%。2月,总部位于圣地亚哥的Viking Therapeutics报告了其每周一次注射的GLP-1和GIP激动剂VK2735的第二阶段数据,显示在治疗13周后,安慰剂调整后的体重平均减轻了13.1%。

A larger and longer Phase 3 study is planned for this molecule. An oral version of the Viking drug is expected to begin a Phase 2 test in obesity by the end of this year..

计划对该分子进行更大更长的3期研究。预计口服维京药物将于今年年底开始肥胖症的第二阶段测试。。

Roche is going after GLP-1 and GIP with CT-388, an injectable peptide from its $2.7 billion acquisition of Carmot Therapeutics last year. In a Phase 1 test, Roche reported the average placebo-adjusted weight loss at 24 weeks was 18.8%. An oral drug included in that M&A deal posted encouraging Phase 1 data over the summer..

罗氏正在用CT-388追踪GLP-1和GIP,CT-388是罗氏去年斥资27亿美元收购Carmot Therapeutics的一种可注射肽。在第一阶段的测试中,罗氏报告称,24周时安慰剂调整后的平均体重减轻率为18.8%。该并购交易中包含的一种口服药物在夏季发布了令人鼓舞的第一阶段数据。。

Kailera’s pipeline also includes oral therapies. The Hengrui deal brought two small molecule programs, KAI7535 and KAI-9531. Kailera’s fourth program is an injectable drug that goes after three targets: GLP-1, GIP, and glucagon receptor. New York-based Metsera has a program that also goes after those three targets.

凯勒拉的管道还包括口服疗法。恒瑞的交易带来了两个小分子项目,KAI7535和KAI-9531。凯勒拉的第四个项目是一种可注射药物,它针对三个目标:GLP-1,GIP和胰高血糖素受体。总部位于纽约的梅瑟拉有一个项目也在追求这三个目标。

Its most advanced program hits only GLP-1, but with a dosing edge of an injection once a month. Last week, Metsera announced Phase 1 results showing 7.5% reduction in body weight measured at day 36. The company, which launched in April backed by $290 million, expects to begin a Phase 2b test of its lead program by the end of this year; preliminary data are expected in the first half of 2025..

其最先进的程序仅能达到GLP-1,但剂量边缘为每月一次注射。上周,梅瑟拉宣布了第一阶段的结果,显示在第36天测得的体重减少了7.5%。该公司于4月成立,资金2.9亿美元,预计在今年年底开始其领先项目的2b阶段测试;初步数据预计将于2025年上半年发布。。

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Kailera’s Series A financing announced Tuesday was co-led by Atlas Venture, Bain Capital Life Sciences, and RTW Investments. Lyra Capital also participated in the round. The company is led by CEO Ron Renaud, who was most recently the chief executive of Cerevel Therapeutics, a neurological diseases drug developer recently acquired by AbbVie..

周二宣布的凯勒A系列融资由Atlas Venture、贝恩资本生命科学和RTW投资共同牵头。天琴座也参加了这一轮。该公司由首席执行官罗恩·雷诺(RonRenaud)领导,他最近担任Cerevel Therapeutics的首席执行官,Cerevel Therapeutics是一家最近被AbbVie收购的神经疾病药物开发公司。。

“In this period of rapid innovation in the metabolic space, I believe that Kailera is poised to make an impact beyond the current market leaders,” Renaud said in a prepared statement. “We have an incredible opportunity to develop next-generation treatments for chronic weight management, helping people reclaim their health and live their lives to the fullest.”.

。“我们有一个绝佳的机会来开发下一代慢性体重管理治疗方法,帮助人们恢复健康,过上最充实的生活。”。

Photo: Jason Dean, Getty Images

照片:杰森·迪恩,盖蒂图片社

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