Despite Phase II Snags, Bayer, BMS and J&J Move Factor XIa Inhibitors Inhibitors to Phase III

2022-08-29

VCG via Getty Images On Sunday, Bayer kicked off its Phase III OCEANIC program, starting with two studies investigating the efficacy and safety of the oral factor XIa inhibitor asundexian in patients with atrial fibrillation or non-cardioembolic ischemic stroke. The announcement follows asundexian’s lukewarm Phase II performance, which was presented at the 2022 Congress of the European Society of Cardiology (ESC). In 2020, Bayer launched a trio of randomized and double-blinded trials under the Phase II PACIFIC program to evaluate asundexian in three cardiovascular ailments: acute myocardial infarction (AMI), acute non-cardioembolic ischemic stroke and atrial fibrillation. In a Hot Line Session at ESC on Sunday, trial investigators reported that asundexian failed to meet its primary endpoint in both the PACIFIC-Stroke and PACIFIC-AMI trials. More than 1,800 patients from around 20 countries participated in PACIFIC-Stroke. They were given 10-mg, 20-mg, or 50-mg doses of asundexian or a placebo control, all on top of standard antiplatelet therapy. While the study drug did not trigger an excess of clinically relevant bleeding events, it was also unable to distinguish itself significantly from placebo in terms of recurrent symptomatic ischemic stroke or MRI-detected covert brain infarcts at six months. Asundexian met the same fate in PACIFIC-AMI, which found that in over 1,600 patients, all three doses of the test drug were just as effective as placebo in preventing the primary composite outcome of cardiovascular death, MI, stroke or stent thrombosis. However, investigators saw promising signals in both Phase II studies. An exploratory analysis of PACIFIC-Stroke, for instance, found that 50-mg asundexian could significantly reduce the risk of recurrent ischemic stroke or transient ischemic attacks, particularly in patients with extra- or intracranial atherosclerotic plaques. Meanwhile, in PACIFIC-AMI, Bayer’s molecule demonstrated a dose-related inhibition of factor XIa, such that the 50-mg treatment suppressed factor XIa function by more than 90%. [Quote explaining the push-through + details for OCEANIC to wrap up this part] BMS and J&J Set Sights on Phase III Like Bayer, the high-pro between Bristol Myers Squib and Janssen Pharmaceuticals also fell short in Phase II evaluations, with their investigational oral factor XIa inhibitor milvexian falling short of its primary endpoint in the AXIOMATIC-SSP study. Enrolling more than 2,300 patients, AXIOMATIC-SSP is a randomized, double-blinded and placebo-controlled study assessing 25-mg, 50-mg and 100-mg doses of milvexian in terms of its primary endpoint, which is a composite between new symptomatic ischemic strokes and MRI-detected covert brain infarctions. While the study drug could not significantly outperform placebo in terms of the primary composite outcome, it nevertheless had a favorable safety pro was able to induce a 30% relative risk decrease in recurrent symptomatic ischemic strokes. With these encouraging findings, along with previous data, the companies are taking milvexian into a Phase III study, which they hope to initiate later this year.

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