Arena reports encouraging results from Phase Ib thrombosis trial

The Phase Ib trial was a randomized, double-blind, placebo-controlled, multiple-ascending dose trial in 50 healthy adult male and female volunteers. Daily doses ranged from 15mg to 240mg and were generally well tolerated.

In addition to evaluating APD791’s safety and tolerability profile, the trial evaluated the pharmacokinetics and pharmacodynamics of multiple oral doses of APD791 over a period of one week. APD791 was rapidly absorbed and exposures were related to dose.

Dose-dependent inhibition of serotonin-mediated amplification of platelet aggregation was demonstrated starting at the 15mg dose and will permit the identification of exposure ranges that produce minimal, moderate and near-complete inhibition of serotonin-mediated platelet aggregation. These results further support APD791’s novel mechanism of action and preclinical and Phase Ia clinical trial data.

William Shanahan, vice president and chief medical officer of Arena, said: “These results support APD791’s potential to treat a variety of central and peripheral conditions related to arterial thrombosis with a novel mechanism that may provide advantages over currently available therapies.”