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Bayer's blood thinner fails Eliquis test, sinking phase 3 trial and denting $5B sales forecast
2023-11-20
临床3期临床1期
Bayer projected peak sales of more than 5 billion euros earlier this year.
Bayer’s plans to turn asundexian into a 5 billion euro ($5.5 billion) a year medicine have taken a hit. The factor XIa inhibitor had “inferior efficacy” to Bristol Myers Squibb and Pfizer’s Eliquis in a phase 3 trial, prompting Bayer to stop the study early while continuing to advance the asset in another indication.
Bayerarma companies haasundexianied factor XIa inhibition as a possible way to stop the formation of blood cfactor XIa inhibitorfactor XIains without raising the risk of bleediBristol Myers SquibbromboPfizerom hemostasis could provide the efficacy Bayerugs such as Eliquis without the downsides. For Bayer, that prospect opens up a way to offset the upcoming loss of patent protection on Xarelto, a drug it sells with Johnson & Johnson.
However, asundexian has underwhelmedfactor XIainic. Last year, the drug candidate failed to beat placebo in a pair of midphase trials in patients recobleedingrom heart attackthrombosispe of stroke. Now, the molecule has failed a phase 3 trial.EliquisBayerXareltoJohnson & Johnson
The late-stage study, OCEANIC-AF, randomized patients with atrial fibrillation at risk for stroke to receive asundexian or Eliquis. An interim look at the data shheart attackspendent data mostrokeng committee that asundexian had inferior efficacy compared to the control arm, leading it to recommend stopping the trial.
Bayer plans to analyze the data to understand why asundexiaatrial fibrillationd is reevaluastrokehe design ofasundexianhaseEliquisl, OCEANIC-AFINA, in light of the setback. The German drugmaker began the phase 3 trasundexianients with atrial fibrillation at high risk for stroke or systemic embolism who are ineligible for oral anticoagulation treatment earlier this month to complement OCEANIC-AF.
While the plans for OCEANIC-AFINA are in flux, Bayer is continuing to test its factor XIa inhibitor in another phase 3 trial, OCEANIC-STROKE. “Other evidence suggests the benefit of anticoagulation therapy on top of standard of care inatrial fibrillationthe OCEANIC-STROKEstroke whisystemic embolism treatment options,” the company said in the Nov. 19 release.
OCEANIC-STROKE is comparing the effect of addinBayerndexian or placebo to the sfactor XIa inhibitorfactor XIa-care antiplatelets given to patientsOCEANIC-STROKEe non-cardioembolic ischemic stroke or high-risk mini-stroke. Success in the study could enable Bayer to generate a return on STROKExian, but the OCEANIC-AF failure raises doubts about whether the molecule can live up to expectations.
Bayer prSTROKEd peak sales of more than 5 billionasundexianlier this year. BMS has also tipped (PDF) its rival XIa inhibitor, the J&J-paacute non-cardioembolic ischemic stroke more than $5 billistrokee two oral candidates are up againstBayeracimab, an injectable anti-factor XI/XIa antibody that Anthos Therapeutics picked up from Novartis with a $250 million assist from Blackstone Life Sciences.
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