Arena (ARNA) Updates on APD811 Phase 1 in PAH Treatment
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Arena Pharmaceuticals, Inc. (Nasdaq: ARNA), reports results from a Phase 1 clinical trial of APD811, an orally bioavailable agonist of the prostacyclin receptor which is intended for the treatment of pulmonary arterial hypertension, or PAH.
From the release: "The randomized, double-blind and placebo-controlled trial evaluated the safety, tolerability and pharmacokinetics of 0.03 mg, 0.05 mg, 0.1 mg and 0.2 mg single doses of APD811. The trial evaluated 32 healthy volunteers in four cohorts of eight participants each – six randomized to APD811 and two to placebo. APD811 was rapidly absorbed and demonstrated dose-proportional pharmacokinetic exposure over the tested dose range. The terminal half-life was approximately 20 hours.
The most frequent treatment-emergent adverse events were headache, vomiting, nausea, jaw pain and flushing. Dose-limiting adverse events of nausea and vomiting occurred at the 0.2 mg dose. As compared to placebo, heart rate trended higher at the 0.05 mg, 0.1 mg and 0.2 mg doses and the corrected QT (QTc) interval trended higher at the 0.1 mg and 0.2 mg doses. Arena believes the QTc observation is not supported by preclinical data and will further evaluate this in future studies. No serious adverse events were reported."
From the release: "The randomized, double-blind and placebo-controlled trial evaluated the safety, tolerability and pharmacokinetics of 0.03 mg, 0.05 mg, 0.1 mg and 0.2 mg single doses of APD811. The trial evaluated 32 healthy volunteers in four cohorts of eight participants each – six randomized to APD811 and two to placebo. APD811 was rapidly absorbed and demonstrated dose-proportional pharmacokinetic exposure over the tested dose range. The terminal half-life was approximately 20 hours.
The most frequent treatment-emergent adverse events were headache, vomiting, nausea, jaw pain and flushing. Dose-limiting adverse events of nausea and vomiting occurred at the 0.2 mg dose. As compared to placebo, heart rate trended higher at the 0.05 mg, 0.1 mg and 0.2 mg doses and the corrected QT (QTc) interval trended higher at the 0.1 mg and 0.2 mg doses. Arena believes the QTc observation is not supported by preclinical data and will further evaluate this in future studies. No serious adverse events were reported."
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