Janssen and Bristol Myers Squibb Launch Phase 3 Clinical Trials in China for Oral Anticoagulant Milvexian

▎WuXi AppTec Content Team Report

China Drug Clinical Trial Registration and Information Disclosure Platform official website announced, Johnson & Johnson（Johnson & Johnson）Launched in ChinaMilvexian TabletsTwo international multicenter (including China) Phase 3 clinical studies, targeting indications respectively:1) Adult Acute Coronary Syndrome (ACS), to prevent thrombotic events in adult patients with ACS; 2) to prevent thrombotic events in adult patients with acute ischemic stroke or high-risk transient ischemic attack (TIA).Ischemic Stroke. Public information shows that milvexian is a product jointly developed by Johnson & Johnson and Bristol-Myers Squibb.A New Generation of Oral Coagulation Factor XIa Inhibitors。

Screenshot source:China Drug Clinical Trial Registration and Information Disclosure Platform Official Website

Factor XIa (FXIa) inhibitors can reduce the incidence of venous thrombosis without significantly affecting bleeding, making them a novel type of antithrombotic drug.Milvexian isA New Generation of Oral Coagulation Factor XIa Inhibitors.Fierce BiotechPoint out, this therapy is expected to become a blockbuster anticoagulant therapy.

In May 2023, Johnson & Johnson and Bristol-Myers SquibbCompany announces milvexian receives U.S. FDA Fast Track designation,All three indications evaluated for the Librexia Phase 3 research project: ischemic stroke, acute coronary syndrome, and atrial fibrillation.。According to an earlier press release from Johnson & Johnson, the Librexia project aims to study whether milvexian can improve the benefit-risk profile for patients with these three conditions by reducing thrombotic events without increasing the risk of bleeding.The study will be conducted globally.Data from 50,000 patients.

The two international multicenter Phase 3 clinical studies launched in China this time aim to proveAfter the recent occurrence of acute coronary syndromeEfficacy and Safety of Milvexian: The Principal Investigator in China for This Study isDr. Wu Hongyi from Zhongshan Hospital, Fudan University,Planned enrollment of 960 participants in China and 16,000 participants internationally.

Another international multicenter Phase 3 clinical study aims to demonstrateAfter Acute Ischemic Stroke or High-Risk Transient Ischemic AttackMilvexian Prevents StrokeThe efficacy and safety. The purpose of this study is to evaluate whether milvexian, compared with placebo, can reduce the risk of ischemic stroke. The principal investigator in China for this study isDr. Zhao Xingquan from Beijing Tiantan Hospital, Capital Medical University, planning to enroll 1,500 people in China and a total of 15,000 people internationally.

Publicly available information shows that in the previously published Phase 2 clinical trial,milvexianCompared with commonly used anticoagulant drugs, in patients undergoing knee replacement surgery,Not only can it significantly reduce postoperative venous thromboembolism, but it also does not increase the risk of bleeding.

[1] China Drug Clinical Trial Registration and Information Disclosure Official Website. Retrieved Nov 3, 2023, from http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml

[2]Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation.  Retrieved May 25， 2023, from https://www.jnj.com/milvexian-granted-u-s-fda-fast-track-designation-for-all-three-indications-under-evaluation-in-phase-3-librexia-program-ischemic-stroke-acute-coronary-syndrome-and-atrial-fibrillation