Biopharmaceutical company Arena Pharmaceuticals has completed a randomised, double-blind and placebo-controlled Phase Ib clinical trial to evaluate the efficacy of multiple-ascending doses of APD811.
An investigational oral prostacyclin (IP) receptor agonist, APD811 is being investigated for the treatment of pulmonary arterial hypertension (PAH), a progressive, life-threatening disorder that increases pressure in the arteries that carry blood from the heart to the lungs.
As part of the trial, around 40 healthy patients received APD811 and 15 received placebo, and the safety profile of APD811 was characteristic of IP receptor agonists, with no serious adverse events reported.
According to the company, IP agonists can slow disease progression and improve exercise tolerance in PAH patients.
Arena believes that an orally available, non-prostanoid IP agonist such as APD811 may have the potential to improve the standard of care for PAH.
Arena senior vice president and chief medical officer Dr William Shanahan said that the company's internal GPCR-focused efforts led to the discovery of this novel drug candidate.
"We believe APD811 is a promising new chemical entity that could improve current patient care by providing an oral option for IP-targeted therapy," Shanahan said.
Based on the Phase I results, the company is planning to start a Phase II clinical trial for APD811 in the first quarter of 2014 to further explore dosing regimens in PAH patients.
Earlier, Arena evaluated single-ascending doses of APD811 as part of a Phase Ia clinical trial.
Image: Plexiform lesion - Pulmonary hypertension. Photo: courtesy of Bulent Celasun, MD.