For many who have skilled a stroke, the probabilities of a second one are excessive. An experimental Bayer drug diminished this threat by 26% in a pivotal trial, supporting the case for this tablet as a possible new remedy possibility for sufferers. For Bayer, the drug brings the chance to be first to market in a brand new class of medicines addressing a big indication providing blockbuster potential.
Bayer introduced this drug, asundexian, met the primary targets of its Part 3 check in secondary stroke prevention final November, however launched no particulars on the time. The corporate did say it could start talking with well being authorities because it prepares for regulatory submissions. Bayer additionally mentioned information can be introduced at an upcoming medical assembly. The info reveal occurred Thursday in the course of the Worldwide Stroke Convention in New Orleans.
Following a stroke, antiplatelet medicine and blood thinners (together with aspirin, which Bayer nonetheless makes) can be utilized to forestall a second stroke. However these medicine improve the danger of bleeding, significantly with prolonged use. Asundexian is a small molecule designed to dam Issue XIa, a protein within the coagulation cascade that performs key roles in hemostasis and thrombosis. By blocking this goal, Bayer hoped to scale back stroke threat with out additionally growing the danger of bleeding.
Bayer evaluated asundexian in OCEANIC-STROKE, a world Part 3 examine that enrolled 12,327 members representing all frequent stroke subtypes. The examine drug was examined alongside antiplatelet remedy and in comparison with a placebo and antiplatelet remedy. The first efficacy endpoint was measuring the time to ischemic stroke; the first security endpoint was the time to the primary incidence of main bleeding.
Apart from assembly the primary aim of lowering the danger of ischemic stroke, the outcomes additionally confirmed asundexian met secondary targets, lowering the danger of stroke of any form by 26%. The protection evaluation confirmed no improve within the fee of main bleeding within the examine drug group in comparison with placebo. In Bayer’s announcement of the outcomes, Dr. Ashkan Shoamanesh, senior scientist at Inhabitants Well being Analysis Institute and co-principal investigator of the examine, mentioned the constant discount in secondary occasions throughout all forms of stroke “is especially putting.”
“OCEANIC-STROKE was intentionally designed with the aim of constructing the findings generalizable to the numerous methods stroke presents in scientific apply,” he mentioned. “These outcomes present confidence that, if permitted, asundexian may develop into an necessary possibility for secondary stroke prevention throughout a broad vary of stroke sufferers.”
Asundexian had beforehand posted disappointing information in one other indication, failing a Part 3 check in atrial fibrillation in 2023. Throughout a convention name final yr to debate 2024 monetary outcomes, Head of the Prescription drugs Division Stefan Oelrich attributed that scientific trial failure to the comparability of the examine drug to a really efficient commonplace remedy in Eliquis, a blood thinner marketed by Bristol Myers Squibb and Pfizer. In contrast, asundexian’s comparator within the stroke examine is a placebo, he mentioned.
Bayer is within the midst of a multi-year turnaround that’s streamlining operations and looking for new drivers of income progress. Asundexian could possibly be a type of drivers. Bayer hasn’t supplied particular monetary projections for the drug, however in the course of the convention name, Oelrich mentioned that if asundexian’s information readout is constructive, the drug may develop into the primary and solely product permitted for secondary stroke prevention.
“I may see positively blockbuster potential for this indication alone,” he mentioned.
Ausndexian might face competitors in its class. Milvexian, a Issue XIa inhibitor in improvement by companions Bristol Myers Squibb and Johnson & Johnsonhas reached Part 3 testing in secondary stroke prevention and atrial fibrillation. However this drug has had its personal stumbles. In November, BMS and J&J discontinued milvexian’s improvement for sufferers who had skilled an acute coronary syndrome occasion. The businesses mentioned a preplanned interim evaluation concluded the Part 3 trial was unlikely to fulfill its major endpoint.
In a analysis be aware, Leerink Companions analyst David Risinger mentioned given the Bayer drug’s Part 3 success in secondary stroke prevention, the agency offers Bristol’s twice-daily tablet an 80% likelihood of success within the indication. Part 3 information for milvexian are anticipated in each stroke prevention and afib later this yr. The sector of Issue XI-inhibiting drug candidates additionally contains two antibodies from Regeneron Prescription drugs, each in mid-stage scientific improvement.
Illustration: Micro Discovery, by way of Getty Photographs
