CagriSema

▲5月30-31日 第八届广州生物医药创新者峰会 扫码立即报名 注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。减肥药赛道已经迅速成为制药行业最热门的研发领域之一。诺和诺德的Wegovy和礼来的Zepbound等该领域的热销药物，意味着人们对后续药物和下一代药物的研发有着浓厚的兴趣。瑞穗(Mizuho Americas)高级生物制药和生物技术股票研究分析师Graig Suvannavejh表示，人们对联合疗法非常感兴趣，重点仍然主要是基于GLP-1的疗法。比如礼来公司的triple-G疗法，它结合并激活GIP、GLP-1和胰高血糖素受体。Suvannavejh补充道，这些药物的口服给药也很有意义，因为它可以通过降低生产成本来降低当前治疗的成本，这将覆盖到更多的患者。外媒biospace总结了4种可改变市场格局的减肥药，虽然该行业的重点一直是注射用GIP/GLP-1药物，但对GLP-1无反应或不能耐受副作用的患者也有其他选择。四种不同给药途径的药物诺和诺德：Cagrilintide和索马鲁肽诺和诺德正在探索索马鲁肽和一种新型胰淀素类似物cagrilintide每周一次的皮下注射联合用药。胰淀素类似物的使用将使公司的联合用药与目前以GIP / GLP - 1资产为主的管线相区别。诺和诺德已经将这种名为CagriSema的联合疗法与礼来的Zepbound进行了三期临床试验。在II期试验中，这两种药物的联合使用对超重的II型糖尿病患者的体重减轻效果更好。CagriSema组体重下降15.6 %，索马鲁肽组体重下降5.1 %，Cagrilintide组体重下降8.1 %。礼来：Orforglipron礼来有多种正在进行III期减肥试验的资产，包括orforglipron，这是一种GLP-1受体激动剂，每天口服一次。2023年6月礼来宣布，在II期试验中，在所有测试剂量下，orforglipron均实现了统计学上显著的剂量依赖性体重减轻。Viking Therapeutics：VK-2735今年2月，Viking Therapeutics公布了其肥胖候选药物VK2735的阳性临床试验结果，这是一种双GLP-1/GIP激动剂，类似于礼来的Zepbound。2期研究结果表明，在安慰剂校正的基础上，该药可使平均体重减轻13.1%。根据上个月第一阶段的结果显示，口服治疗可以减少平均体重。此外，服用VK2735后28天很少有胃肠道不良事件报告，这可能是一个重要的区分因素，因为这些副作用是GLP-1药物的主诉。除了礼来和诺和诺德的产品组合外，VK2735是临床开发进展最快的产品之一，这也意味着，该公司未来可能成为收购目标。Inversago Pharma：INV-202CB1受体阻滞剂是一种鲜为人知的候选药物，但有诺和诺德的财力支持，它可能是减肥疗法的另一个攻击角度。2023年6月，在诺和诺德以10亿美元收购INV-202的两个月前，Inversago公布了INV-202的Ib期试验结果。INV-202是一种口服药物，在28天的时间里，接受该药物治疗的患者平均减重7.7磅，而安慰剂对照组平均减重1.2磅。该治疗被专门设计为阻断外周组织中的CB1受体，以避免先前与靶向该通路相关的不良事件。总结摩根大通预测到 2030 年，仅GLP-1市场的收入就将超过 1000 亿美元，用于治疗糖尿病和肥胖症。根据IQVIA的数据，2023年肥胖药物的临床试验数量比2022年增长了68%，有124种药物正在积极开发中，其中40%是GLP-1或葡萄糖依赖性促胰岛素肽（GIP）受体的激动剂。参考资料：www.biospace.com版权声明：本文转自生物药大时代，如不希望被转载的媒体或个人可与我们联系，我们将立即删除 活动推荐  5月 • 第八届大湾区生物医药创新者峰会  关键词：  小分子，XDC，多肽及GLP-1热点话题，80+行业专家（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

Pictured: Four medicines with different routes of administration/Nicole Bean for BioSpace. Weight-loss treatments have quickly emerged as one of the hottest areas for R&D in the pharmaceutical industry. The rapidly realized blockbuster sales of the leading drugs in the space, Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, means there is a strong interest in the pipeline of follow-on and next-generation drugs. J.P. Morgan forecasts that the glucagon-like peptide-1 (GLP-1) market alone will exceed $100 billion in revenue by 2030, through the use of these medicines in diabetes and obesity. According to IQVIA, the number of clinical trials for obesity drugs in 2023 was up by 68% from 2022, with 124 drugs in active development—of these, 40% are agonists of either the GLP-1 or glucose-dependent insulinotropic peptide (GIP) receptor. “The focus continues to be mainly GLP-1-based therapies,” Graig Suvannavejh, senior biopharmaceuticals and biotechnology equity research analyst at Mizuho Americas, told BioSpace, adding that there is a significant interest in combination approaches, such as Eli Lilly’s ‘triple-G’ approach, which binds and activates the GIP, GLP-1 and glucagon receptors. Suvannavejh said the oral delivery of these medicines is also of significant interest, as it could lower the cost of current peptide treatments by enabling lower manufacturing costs. This would allow for a greater number of patients to receive these types of treatments, he said. Of the assets that are moving through the pipeline, BioSpace highlights four potentially market-changing treatments. Though the focus of the industry’s pipeline has been on injectable GIP/GLP-1 assets, the leading companies have recognized the need to also approach the development of medicines from a new angle. Novo Nordisk’s Cagrilintide and Semaglutide Novo Nordisk is exploring a once-weekly subcutaneous combination of semaglutide and a novel amylin analog, cagrilintide. The use of an amylin analog would differentiate the company’s treatment portfolio from the current pipeline dominated by GIP/GLP-1 assets. Novo has already set the combination treatment, known as CagriSema, head-to-head against Eli Lilly’s Zepbound in a Phase III trial. In Phase II, the combination demonstrated greater body weight reduction in overweight people with type II diabetes. Body weight reduction was 15.6% with CagriSema compared to 5.1% in the semaglutide-only group and 8.1% in the cagrilintide-only group. Eli Lilly’s Orforglipron Eli Lilly has various assets in Phase III trials for weight loss, including orforglipron, which is a GLP-1 receptor agonist that is delivered as a once-daily oral treatment. Leaders in this space are racing to be the first-to-market with an oral treatment. This could be significant in garnering market share due to the aforementioned manufacturing advantages and the fact that oral delivery is generally preferable to subcutaneous delivery. In Phase II trials, orforglipron achieved statistically significant dose-dependent body weight reductions for all doses tested, according to Lilly’s June 2023 announcement. Viking Therapeutics’ VK-2735 In February, Viking Therapeutics revealed positive clinical trial results for its obesity candidate, VK2735—a dual GLP-1/GIP agonist, similar to Lilly’s Zepbound. Phase II results showed that the drug was able to achieve up to 13.1% placebo-adjusted mean weight loss. Then, last month, Phase I results revealed that an oral formulation of the treatment led to reductions in mean body weight. There were very few gastrointestinal adverse events reported 28 days after receiving VK2735, which could be an important differentiator as these side effects are a chief complaint associated with GLP-1 medicines. “Viking is viewed as one of the companies at the forefront of working on an oral formulation,” Suvannavejh said. The company noted in its Phase I data announcement that it would explore “longer treatment windows and potentially higher doses” in Phase II. Suvannavejh said this is because tolerability of the treatment appeared to be “quite good.” Outside of Lilly and Novo Nordisk’s portfolios, VK2735 is one of the furthest along in clinical development, so these data could signal the approach of a third player on the market—whether that be Viking or a future suitor of the company, with Suvannavejh suggesting that the company could be an acquisition target in the future. Inversago Pharma’s INV-202 A lesser-known drug candidate but backed by Novo Nordisk’s financial firepower, the CB1 receptor blocker could be another angle of attack for weight loss therapies. In June 2023, two months before Novo Nordisk’s $1 billion buyout, Inversago posted Phase Ib results for INV-202, an oral treatment, which elicited an average weight loss of 7.7 pounds for those treated with the candidate over a 28-day period, compared to 1.2 pounds for placebo comparators. The treatment has been specifically designed to block CB1 receptors in peripheral tissues to avoid the adverse events previously associated with the targeting of this pathway. Suvannavejh said these four treatments could be positioned as “combination approaches, and in patients who do not respond to GLP-1 or cannot tolerate the side effects.” Ben Hargreaves is a freelance science journalist based in Tosse, France. Reach him on LinkedIn.