This company—a longstanding recommendation of ours—has been an unexpected star at the American Society of Hematology (ASH) meeting, explains John McCamant, biotech expert and editor of The Medical Technology Stock Letter.
Isis Pharmaceuticals (ISIS) released the final Phase II data for ISIS-FXI at ASH and was also published in the New England Medical Journal.
The data showed a significant reduction (seven-fold at highest dose) in the incidence of venous thromboembolic events (VTE) in patients treated with ISIS-FXI undergoing total knee arthroplasty (TKA).
In the paper and presentation titled Factor XI Antisense Oligonucleotide for Prevention of Venous Thrombosis, the authors report that ISIS-FXI-treated patients experienced a dose-dependent decrease in venous thromboembolic events.
Patients treated with 300 mg of ISIS-FXI experienced a seven-fold lower rate of VTE as compared with those treated with enoxaparin (4.2% and 30.4%, respectively; pRx had a rate of VTE comparable to that in patients treated with enoxaparin (26.9% and 30.4%, respectively).
Safety was excellent with no observed differences in safety outcomes compared with enoxaparin. In particular, there were no flu-like symptoms and injection site reactions were infrequent and mild.
ISIS will start additional Phase II trials in patients with the greatest unmet needs and look for a major partner that can handle the heavy lifting required to run large Phase III trials. The two Phase II trials will be in patients with atrial fibrillation and patients with end-stage renal disease.
Both of these patient sets are at the highest risk of stroke, but because the risk of bleeding in these patients is so high, they are rarely prescribed anticoagulants. ISIS-FXI has the potential to change this and significantly expand the market opportunity for anticoagulants.
In our view, ISIS-FXI has the potential to be a best-in-class antithrombotic drug and should be useful in many different therapeutic settings, including patients at high-risk for thrombosis and high risk of bleeding.
The publication in the New England Journal of Medicine is a major validation for this exciting drug candidate and marks the second time in just one week that ISIS
has had cutting edge Phase II data published in the premiere scientific journal.
FXI and APOCIII are both ripe for major partnerships that would serve as significant catalysts for the stock, one of which could be announced any time. ISIS is a buy under $55 with a target price of $70.
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