Prospects for Bayer’s oral Factor XIa inhibitor asundexian were looking speculative when it failed a phase 3 trial in atrial fibrillation (AF), but new data in secondary stroke prevention could get the programme back on track.
The results of the OCEANIC-STROKE study reveal that asundexian was more effective than placebo when given on top of standard antiplatelet therapy in reducing the risk of a new ischaemic stroke in patients who had already had one stroke or a serious ‘mini-stroke’ or transient ischaemic attack (TIA).
Crucially, the addition of the Factor Xia inhibitor to antiplatelet therapy did not appear to raise the risk of bleeding-related side effects, which is a perennial concern with anti-clotting therapies.
Only the top-line result is available for now, but Bayer has said it will present the data at a future medical congress and intends to start discussions with regulatory authorities around the world about filing asundexian for approval in secondary stroke prevention.
The announcement comes just a few days after Bauer’s main rivals in the oral Factor Xia category, Bristol Myers Squibb and Johnson & Johnson, stopped the development of their milvexian candidate in acute coronary syndrome after a disappointing result in the phase 3 Librexia ACS trial.
BMS and J&J are, however, still running phase 3 trials of the drug in both AF and stroke, with results due next year. Meanwhile, there are other Factor Xia-targeting drugs coming through the industry pipeline, including Anthos Therapeutics’ antibody-based abelacimab – now being developed by Novartis following a $3.1 billion takeover deal earlier this year – and MSD/Adimab’s MK-2060 antibody.
According to Bayer, there are around 12 million strokes recorded every year worldwide, and up to a third of them will be a recurrent stroke. Moreover, despite current secondary prevention options, one in five patients having an ischaemic stroke will have another within the next five years, with the risk of death rising sharply.
The positive result in OCEANIC-STROKE means that asundexian can potentially now sit alongside prostate cancer therapy Nubeqa (darolutamide) and kidney disease treatment Kerendia (finerenone) as a near-term sales growth driver for Bayer.
That is important, as the company is in the midst of a major turnaround plan and facing a challenging period due to generic competition for drugs like Factor Xa inhibitor Xarelto (rivaroxaban) and litigation liabilities, and looking to a new generation of products to restore sales and profit growth.
“We are excited by these positive topline findings which highlight the potential of Factor XIa inhibition as a new way to help protect patients from a recurrent stroke,” commented Bayer’s pharma R&D chief, Christian Rommel.
“This marks an important milestone in Bayer’s longstanding commitment to advancing innovation in thrombosis prevention.”
Photo by Christian Harb on Unsplash
