Dive Brief:

潜水简介：

An experimental drug co-developed by Teva and Sanofi met its main objectives in a mid-stage clinical trial in inflammatory bowel disease, showing what the partners claimed to be “best-in-class potential.”

Teva和赛诺菲联合开发的一种实验药物在炎症性肠病的中期临床试验中达到了其主要目标，显示了合作伙伴声称“同类最佳潜力”

Around half of people with ulcerative colitis who received a high dose of the drug, duvakitug, in a Phase 2 trial had their symptoms resolve after 14 weeks, versus just over 20% of those on placebo. A similar, roughly 48% of Crohn’s disease patients given a high dose of duvakitug experienced meaningful improvement on a measure of disease severity, compared to 13% of people on placebo, Sanofi and Teva said Tuesday..

在一项2期试验中，大约一半接受大剂量duvakitug药物治疗的溃疡性结肠炎患者在14周后症状缓解，而安慰剂组患者的症状缓解率略高于20%。赛诺菲和特瓦周二表示，与安慰剂组13%的患者相比，大约48%的克罗恩病患者在服用高剂量duvakitug后在疾病严重程度方面有了显着改善。。

The companies didn’t provide details, which will be presented at a medical meeting next year. Still, they said the drug’s effects were consistent across subgroups and rates of treatment-related side effects were similar between both study groups. The partners intend to start late-stage development, pending discussions with regulators..

这些公司没有提供细节，这些细节将在明年的医疗会议上公布。尽管如此，他们表示，该药物在各亚组中的作用是一致的，两个研究组之间与治疗相关的副作用发生率相似。合作伙伴打算在与监管机构讨论之前开始后期开发。。

Dive Insight:

潜水洞察：

While the results are from a short Phase 2 trial, Sanofi and Teva’s findings suggest duvakitug could be the most potent drug among a handful of closely watched antibody therapies for inflammatory bowel disease, or IBD, wrote Jefferies analyst Peter Welford.

杰弗里斯（Jefferies）分析师彼得·韦尔福德（PeterWelford）写道，虽然结果来自一项短期的2期试验，但赛诺菲（Sanofi）和特瓦（Teva）的研究结果表明，duvakitug可能是少数备受关注的炎症性肠病（IBD）抗体疗法中最有效的药物。

These drugs are aimed at a protein called TL1A, which regulates inflammation and fibrosis. They’ve caught the attention of pharmaceutical companies because of their potential to drive hard-to-treat cases of IBD into remission more powerfully and durably than existing treatments.

这些药物针对一种称为TL1A的蛋白质，该蛋白质可调节炎症和纤维化。它们引起了制药公司的注意，因为它们有可能比现有的治疗方法更有效和持久地将难以治疗的IBD病例缓解。

Merck & Co. spent nearly $11 billion on Prometheus Biosciences in April 2023 largely to get a hold of a TL1A blocker that had shown promise in Phase 2 testing for instance. Roche followed with a $7 billion purchase of Televant months later and, earlier this year, AbbVie joined the chase, too.

2023年4月，默克公司在普罗米修斯生物科学公司（Prometheus Biosciences）上花费了近110亿美元，主要是为了获得一种TL1A阻滞剂，该阻滞剂在第二阶段测试中显示出了前景。几个月后，罗氏斥资70亿美元收购了Televant，今年早些时候，AbbVie也加入了追逐。

Duvakitug trails Merck’s and Roche’s prospects; Merck has already initiated Phase 3 testing. But Teva’s executives have long argued the drug could prove superior and, in Oct. 2023, Sanofi bought in, paying Teva $500 million to collaborate on development. The drug has since become more important to both companies, giving Teva — known for its generics — a chance at a branded blockbuster medicine, and Sanofi an opportunity to build investor confidence in its pipeline..

Duvakitug落后于默克和罗氏的前景；默克公司已经启动了第三阶段测试。但梯瓦的高管长期以来一直认为，这种药物可能会被证明具有优越性，2023年10月，赛诺菲收购了梯瓦，斥资5亿美元与梯瓦合作开发。此后，该药对两家公司都变得越来越重要，使以仿制药闻名的特瓦有机会获得品牌畅销药，而赛诺菲也有机会建立投资者对其渠道的信心。。

While cross-trial comparisons can mislead, duvakitug’s performance in Phase 2 testing appears strong. Merck’s drug led to a placebo-adjusted remission rate of 25% in a Phase 2 trial in ulcerative colitis. Roche’s therapy was associated with an 18 to 23 percentage-point difference versus placebo in a similar trial, depending on the dose..

虽然交叉试验比较可能会产生误导，但duvakitug在第二阶段测试中的表现似乎很强。在溃疡性结肠炎的2期临床试验中，默克公司的药物使安慰剂调整后的缓解率达到25%。在类似的试验中，罗氏的治疗与安慰剂相比有18到23个百分点的差异，具体取决于剂量。。

Duvakitug’s roughly 27% delta, and higher rates of disease improvement in Crohn’s disease, suggest the drug’s different design versus its peers “could perhaps translate to better efficacy,” wrote Jefferies analyst Welford.

Jefferies分析师Welford写道，Duvakitug大约有27%的delta，克罗恩病的疾病改善率更高，这表明该药物与同类药物的不同设计“可能会转化为更好的疗效”。

“If the magnitude of effect persists in the Phase 3 program, we believe we will have a differentiated medicine for IBD,” said Sanofi R&D chief Houman Ashrafian, in the companies’ statement.

赛诺菲研发主管霍曼·阿什拉菲安（HoumanAshrafian）在公司声明中表示：“如果第三阶段计划的效果持续下去，我们相信我们将有一种针对IBD的差异化药物。”。

Teva shares surged nearly 20% in early Tuesday trading, while Sanofi’s climbed by almost 5%.

Teva股价在周二早些时候飙升近20%，而赛诺菲股价上涨近5%。

The program’s advancement into Phase 3 will trigger a $600 million milestone payment from Sanofi to Teva.

该计划进入第三阶段将引发赛诺菲向特瓦支付6亿美元的里程碑式付款。