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2022-08-29| Trials & Approvals

Bristol Myers Squibb’s New Drug Boasts Strong Anti-thrombotic Profile

by Max Heirich
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On August 28, Bristol Myers Squibb announced their phase 2 study of Milvexian demonstrated favorable results. Milvexian is a potential treatment for major thrombotic conditions, developed in collaboration with Janssen Pharmaceuticals. The anti-thrombotic data found in the trials warrants further testing in a Phase 3 trial. 

Related Article: Merck’s Anticoagulant Therapy Scores Fast Track Designation From FDA

Thrombotic Conditions and their current treatments

Thrombotic conditions are disorders caused by thrombosis, the formulation of blood clots in blood vessels. Typically, there is a balance between clotting and anti-clotting forces in the body. However, genetic, acquired, or environmental factors can lead to excess clotting. The blood clots then have the potential to break apart and travel to various organs in the body, causing further issues like heart attacks and strokes.

Treatments for thrombosis include medications inhibiting the production of Factor XIa and XI the proteins responsible for activation and amplification of coagulation. Excess amounts of this protein lead to thrombosis.An example is Merck’s MK-2060, which recently received Fast Track designation from the FDA.

Bristol Myers Squibb’s Milvexian works slightly differently as, rather than inhibit Factor XI, it inhibits its activated version Factor XIa. A clinical trial recently tested the efficacy and safety of this novel drug, finding that it yielded positive anti-thrombotic results. 

AXIOMATIC-SSP Trial Demonstrates an Anti-thrombotic Profile

AXIOMATIC-SSP was a Phase 2 study evaluating the efficacy and safety of Milvexian. The results showed an overall 30% risk reduction of bleeding compared to the placebo. In addition, the data demonstrated no bleeding increase and no fatal bleeding.

The results of the AXIOMATIC-TKR trail further backed up the findings of AXIOMATIC-SSP. The sister trial similarly evaluated the safety and efficacy of Milvexian, however, in patients undergoing elective total knee replacement (TKR) surgery. The primary endpoint was the prevention of thrombosis in patients for up to 14 days. The results, published in The New England Journal of Medicine, demonstrated no increase in bleeding. Although some patients still developed thrombosis, those who received higher doses developed it less frequently.

On the results, Puneet Mohan, MBBS, M.D., Ph.D. vice president of Milvexian Clinical Development at Bristol Myers Squibb, said, “The AXIOMATIC-SSP results, together with previously reported findings from the Phase 2 study of Milvexian in total knee replacement, further reinforce our confidence in this asset and we expect to initiate our broad Phase 3 program later this year.”

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