Arena Pharmaceuticals Announces Positive Phase 1b Clinical Trial Results of APD791 for the Treatment of Arterial ...( SAN DIEGO July 9 /- Arena Pharmac...),Health

SAN DIEGO, July 9 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced positive results from a multiple-ascending dose Phase 1b clinical trial of APD791 to evaluate the compound's safety, pharmacokinetics and pharmacodynamics. APD791 is Arena's internally discovered oral drug candidate intended for the treatment of arterial thrombosis and other related conditions.

The Phase 1b trial was a randomized, double-blind, placebo-controlled, multiple-ascending dose trial in 50 healthy adult male and female volunteers. Daily doses ranged from 15 mg to 240 mg and were generally well tolerated. The most frequently reported adverse event was headache, which was more common in the placebo group than in any APD791 dose group. None of the adverse events occurred in a dose-related fashion with the exception of epistaxis (nose bleed), which occurred in two volunteers in the 240 mg group, a dose outside the anticipated therapeutic range.

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 15 mg 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 1a clinical trial data.

"These results support APD791's potential to treat a variety of central and peripheral conditions related to arterial thromb
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