TAK 442

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TAK in Acute Coronary Syndrome Patients

On October 26, 2010 Takeda announced the top line data from a phase 2 study of TAK-442, an oral anticoagulant, biologically active factor Xa inhibitor (fXai). "This phase 2, multi-center, randomized double blind, placebo-controlled study conducted globally except in Japan was designed to evaluate the safety and tolerability of multiple doses and regimens (10mg BID to 120mg BID) of TAK-442 with placebo in subjects with a recent acute coronary syndrome (ACS) event, in addition to standard treatment (aspirin or dual anti-platelet therapy) for prevention of recurrent ischemic or thromboembolic events."

"The primary safety endpoint was defined as incidence of major bleeding events as defined by the thrombolysis in myocardial infarction (TIMI) scale, which were observed during the 24-week treatment period. In the lower doses there was a low rate of bleeding and in the higher dose groups, the bleeding rates were generally higher than that of placebo."

"The primary efficacy endpoint in the study was a composite of cardiovascular events, consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or myocardial ischemia requiring hospitalization. The study did not demonstrate a positive trend to reduced risk of cardiovascular events for TAK-442 in this ACS patient population, and there was no evidence for a dose-response. Further analyses are underway to better understand the data as well as the possibility of other development strategies. Decisions are expected to be made as soon as the analysis is complete. "