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Apellis to Present New Data Reinforcing EMPAVELI™ (pegcetacoplan) Efficacy and Safety in Patients with PNH at the 2021 ASH Annual Meeting
Results from positive Phase 3 PRINCE study in treatment-naïve patients with PNH accepted for oral presentation In new analysis, EMPAVELI demonstrated
About this update from Apellis Pharmaceuticals, Inc.
[{"type":"text","content":"Results from positive Phase 3 PRINCE study in treatment-naïve patients with PNH accepted for oral presentation In new analysis, EMPAVELI demonstrated clinically meaningful improvements in key markers of disease in PNH patients with baseline hemoglobin levels greater than or equal to 10.0 g/dL WALTHAM, Mass., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that five abstracts were accepted for presentation at the American Society of Hematology (ASH) Annual Meeting to be held December 11-14, 2021. The new data further support the positive efficacy and safety profile of EMPAVELI, the first and only targeted C3 therapy, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Highlights include the first oral presentation of the positive Phase 3 PRINCE study of EMPAVELI in adults with PNH who are treatment-naïve, meaning they had not received a complement inhibitor within three months before entering the study. As previously reported, EMPAVELI demonstrated superiority in both hemoglobin stabilization and reduction in lactate dehydrogenase (LDH) compared to standard of care, which did not include complement inhibitors, at Week 26. Additionally, in a new post hoc analysis of the PRINCE, PEGASUS, and PADDOCK studies, EMPAVELI demonstrated clinically meaningful improvements in key markers of disease in PNH patients with pre-study hemoglobin levels greater than or equal to 10.0 g/dL. This highlights the potential of EMPAVELI to elevate the standard of care for all patients with PNH regardless of previous hemoglobin levels. The analysis included treatment-naïve patients and patients who were taking eculizumab, a C5 inhibitor. “The data that we are presenting at ASH underscore our leadership in PNH as well as the potential of EMPAVELI to redefine treatment for all adults with this debilitating disease,” said Federico Grossi, M.D., Ph.D., chief medical officer of Apellis. “EMPAVELI demonstrated superiority to eculizumab in improving hemoglobin levels in PNH in our PEGASUS study and further evidence shows that EMPAVELI provides meaningful improvements in the treatment-naïve patient population.” Accepted abstracts at ASH 2021 include: Oral presentation: Efficacy and Safety of Pegcetacoplan Treatment in Complement-Inhibitor Naïve...