Arena reports positive Phase Ia results for thrombosis drug

The trial involved 90 healthy male and female volunteers. Doses originally intended for study ranged from 1mg to 160mg, but due to excellent tolerability the maximum dose was increased to 320mg. Doses were well-tolerated, without any dose-related adverse events, such that a maximum tolerated dose could not be defined despite achieving high concentrations in blood.

Based on the positive Phase Ia results, a randomized, placebo-controlled, double-blind, multiple-ascending dose Phase Ib trial was initiated in up to 50 healthy male and female volunteers aged between 19 and 45 years. In addition to evaluating APD791’s safety and tolerability profile, the trial will also evaluate the pharmacokinetics and pharmacodynamics of multiple oral doses of APD791 over a period of one week. Results from the Phase 1b trial are anticipated in mid-2008.