Replies to post #243645 on Biotech Values

[DewDiligence]

Bayer enrolls first phase-3 patients for FXIa inhibitor, Asundexian:

https://www.businesswire.com/news/home/20230208005322/en

• The OCEANIC program will investigate the efficacy and safety of asundexian (BAY2433334) in the prevention of stroke in patients with atrial fibrillation and also patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA)

• OCEANIC-AF and OCEANIC-STROKE are expected to enroll more than 27,000 patients in over 40 countries

Bayer’s competition in this arena is BMY/JNJ’s Milvexian (#msg-169818942, #msg-169841711), which is awaiting the start of phase-3.

[DewDiligence]

BMY/JNJ unveil_phase-3_program_for Milvexian—50,000 patients_across_three_ trials_in secondary stoke prevention, ACS, and AF/primary stroke prevention:

https://www.businesswire.com/news/home/20230228006466/en

Enrollment has begun for the Librexia STROKE trial, which is evaluating milvexian in addition to standard of care antiplatelet therapy for stroke prevention in patients after an acute ischemic stroke or high-risk transient ischemic attack. The Librexia ACS trial, which will evaluate event reduction in acute coronary syndromes in addition to standard of care antiplatelet therapy, and the Librexia AF trial, which will investigate milvexian compared to apixaban [Eliquis] in the prevention of stroke in patients with atrial fibrillation, will also initiate during the first half of 2023.

Milvexian is an oral FXIa inhibitor. The phase-3 trial in secondary stroke prevention is at: https://www.clinicaltrials.gov/ct2/show/NCT05702034 .

The commercial impetus for the Milvexian program is to supersede Eliquis (BMY) and Xarelto (JNJ) when those drugs go off-patent or become subject to Medicare price-setting. The competition for Milvexian is Bayer’s Asundexian, another oral FXIa inhibitor that started a somewhat less aggressive phase-3 program (#msg-169841711) that does not have a trial for ACS.