Apellis doses first patient in Phase 3 study of APL-2
Apellis Pharmaceuticals announced the dosing of the first patient in the Phase 3 clinical study PRINCE, evaluating the efficacy and safety of APL-2 for treatment-naive patients with paroxysmal nocturnal hemoglobinuria. PRINCE is the second Phase 3 study that Apellis has initiated to investigate the potential of APL-2 to treat PNH. The PRINCE study is a Phase 3, randomized, multicenter, open-label, controlled study that aims to enroll 54 treatment-naive adult patients with PNH. The primary objective of this study is to evaluate the efficacy of APL-2 in patients with PNH who are currently not being treated with complement inhibitors, as assessed by hemoglobin stabilization from baseline in the absence of transfusion through Week 26 and reduction in lactate dehydrogenase level from baseline to Week 26.