Shares of Bristol Myers Squibb (NYSE: BMY) slipped ~5%posting the biggest intraday loss since June 2020 on Monday after the company and its partner, the Janssen unit of Johnson & Johnson (JNJ), announced phase 2 data for the anticoagulant milvexian.
The AXIOMATIC-SSP study tested the oral factor XIa inhibitor (FXIa) on five dosing regimens in patients receiving dual antiplatelet therapy, aspirin, and the anticoagulant clopidogrel after acute ischemic stroke or transient ischemic attack (AIT).
The 2,236-subject global trial was designed to assess the potential of milvexian in preventing a new symptomatic ischemic stroke or new hidden cerebral infarction.
The companies said the trial did not achieve the primary objective of finding a dose response for the composite endpoint of symptomatic ischemic stroke + hidden cerebral infarction detected by MRI.
In patients who received 25, 50 or 100 mg of milvexian twice daily, there was an approximately 30% reduction in the risk of symptomatic ischemic stroke compared to placebo.
Puneet Mohan, BMY Vice President, Milvexian Program, said the AXIOMATIC-SSP data and an earlier mid-stage dataset for the total knee arthroplasty candidate “further strengthens our confidence in this asset, and we anticipate to launch our extensive Phase 3 program later this year.”
Bank of America analysts led by Geoff Meacham agreed. “Overall, we thought the data was mixed but small enough to move into phase 3,” they added.
BofA noted that even without a dose-response, the drug was linked to fewer symptomatic ischemic strokes at all doses except the 200 mg BID dose.
The company reiterated the buy rating and $80 per share target on BMY, citing the company’s strong product portfolio.
Meanwhile, German pharmaceutical company Bayer (OTCPK:BAYZF) (OTCPK:BAYRY) has announced the start of two phase 3 trials this week for its oral factor XIa (FXIa) inhibitor asundexian to test its potential in preventing strokes.
The OCEANIC program is expected to enroll up to 30,000 patients with atrial fibrillation and patients with noncardioembolic ischemic stroke or high-risk transient ischemic attack, Bayer (OTCPK:BAYZF) said.
Eliquis and Xarelto, another type of antiplatelet agents known as factor Xa inhibitors developed by Bristol Myers (BMY)/Pfizer (PFE) and Johnson & Johnson (JNJ) generated $10.8 billion and $2.4 billion in revenue for 2021.