For individuals who have had a stroke, the danger of a second stroke is excessive. An experimental Bayer drug lowered this threat by 26% in a pivotal research, supporting the case for this capsule as a possible new therapy choice for sufferers. For Bayer, the drug affords the chance to be first to market in a brand new class of medicine that focus on a big indication and supply blockbuster potential.

Bayer introduced that this drug, asundexian, met key goals of its Section 3 trial in secondary stroke prevention final November, however didn’t launch particulars on the time. The corporate did say it could discuss to well being authorities because it prepares for submissions from regulators. Bayer additionally stated the information can be introduced at an upcoming medical assembly. The information will probably be revealed Thursday on the Worldwide Stroke Convention in New Orleans.

After a stroke, antiplatelet medication and blood thinners (together with aspirin, which Bayer nonetheless makes) can be utilized to forestall a second stroke. However these drugs enhance the danger of bleeding, particularly with long-term use. Asundexian is a small molecule designed to dam Issue XIa, a protein within the clotting cascade that performs a key position in hemostasis and thrombosis. By blocking this goal, Bayer hoped to cut back the danger of stroke with out additionally growing the danger of bleeding.

Bayer evaluated asundexian in OCEANIC-STROKE, a worldwide Section 3 trial that enrolled 12,327 individuals representing all widespread stroke subtypes. The research drug was examined alongside antiplatelet brokers and in contrast with a placebo and antiplatelet brokers. The first efficacy endpoint was measuring time to ischemic stroke; the first security endpoint was time to first prevalence of main bleeding.

Along with reaching the primary aim of decreasing the danger of ischemic stroke, the outcomes additionally confirmed that asundexian achieved secondary targets, decreasing the danger of stroke of any type by 26%. The security evaluation confirmed no enhance within the fee of main bleeding within the research drug group in comparison with placebo. In Bayer’s announcement of the outcomes, Dr. Ashkan Shoamanesh, senior scientist on the Inhabitants Well being Analysis Institute and co-principal investigator of the research, stated the constant discount in secondary occasions throughout all forms of strokes “is especially putting.”

“OCEANIC-STROKE was purposefully designed with the intention of creating the findings generalizable to the various methods stroke happens in scientific follow,” he stated. “These outcomes present confidence that asundexian, if accredited, might change into an vital choice for secondary stroke prevention in a variety of stroke sufferers.”

Asundexian had beforehand posted disappointing knowledge for one more indication, failing a Section 3 trial for atrial fibrillation in 2023. Throughout a convention name final 12 months to debate 2024 monetary outcomes, Stefan Oelrich, chief pharmaceutical officer, attributed the scientific trial failure to the comparability of the investigational drug with a extremely efficient commonplace therapy in Eliquis, a blood thinner marketed by Bristol Myers Squibb and Pfizer. In distinction, asundexian’s comparator within the stroke research is a placebo, he stated.

Bayer is within the midst of a multi-year turnaround that’s streamlining its operations and in search of new drivers of income progress. Asundexian might be a type of drivers. Bayer didn’t present particular monetary projections for the drug, however through the convention name, Oelrich stated that if asundexian’s knowledge is optimistic, the drug might change into the primary and solely product accredited for secondary stroke prevention.

“I undoubtedly noticed blockbuster potential for this indication alone,” he stated.

Ausndexian might face competitors in its class. Milvexian, a Issue XIa inhibitor in growth by companions Bristol Myers Squibb and Johnson & Johnson, has reached Section 3 testing in secondary stroke prevention and atrial fibrillation. However this drug has had its personal stumbles. In November, BMS and J&J stopped creating milvexian for sufferers who had skilled acute coronary syndrome. The businesses stated a pre-planned interim evaluation confirmed the Section 3 trial was unlikely to satisfy its major endpoint.

In a analysis be aware, Leerink Companions analyst David Risinger stated given the Bayer drug’s Section 3 success in stopping secondary strokes, the corporate provides Bristol’s twice-daily capsule an 80% likelihood of success for the indication. Section 3 knowledge for milvexian is predicted later this 12 months for each stroke and afib prevention. The sector of Issue XI inhibitor drug candidates additionally consists of two antibodies from Regeneron Prescribed drugs, each in mid-clinical growth.

Illustration: Micro Discovery, through Getty Photographs