APD811, an orally available agonist of the prostacyclin (IP) receptor, is an internally discovered investigational drug candidate intended for the treatment of Pulmonary Arterial Hypertension (PAH). Treatment with IP agonists, which can slow disease progression and improve exercise tolerance in PAH patients, is considered standard of care for advanced PAH. Currently available IP agonists belong to the prostanoid class of molecules, and these products need to be administered frequently or continuously through intravenous, subcutaneous or inhaled delivery methods. We believe that an orally available, non-prostanoid IP agonist that provides clinical benefits similar to currently available IP agonists has the potential to improve the standard of care for PAH.
Pulmonary Arterial Hypertension (PAH) is a progressive, life-threatening disorder characterized by increased pressure in the arteries that carry blood from the heart to the lungs. The increased pressure strains the heart, which can limit physical activity, result in heart failure and reduce life expectancy. Based on data from the Registry to EValuate Early And Long-term PAH disease management (REVEAL) of patients in the United States, there is an estimated five-year survival rate of 57% from diagnosis.
APD811 has completed single- and multiple-ascending dose Phase 1 trials in healthy volunteers. We are currently evaluating APD811 in an additional cohort as part of the Phase 1 clinical trial program. This additional cohort is intended to optimize the dosing regimen prior to potentially initiating a Phase 2 trial.
APD811 has not been approved by the US Food and Drug Administration or any other regulatory agency.