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Apellis-Sobi Partnered Pegcetacoplan Shows Clinically Meaningful Improvements in Rare Blood Disorder Study

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  • Apellis Pharmaceuticals Inc (NASDAQ: APLS) and Swedish Orphan Biovitrum AB (SOBI) have reported positive top-line results from the Phase 3 PRINCE study evaluating Empaveli (pegcetacoplan) in treatment naïve paroxysmal nocturnal hemoglobinuria (PNH) patients.

  • Empaveli demonstrated statistical superiority on the co-primary endpoints of hemoglobin stabilization and reduction in lactate dehydrogenase (LDH) compared to standard of care, which did not include complement inhibitors, at Week 26.

  • 86% of Empaveli-treated patients achieved hemoglobin stabilization compared to 0% of patients on standard of care.

  • Mean LDH in the Empaveli group decreased by 90% from a baseline, compared to 14%.

  • Mean hemoglobin levels in the Empaveli group increased from 9.4 g/dL to 12.1 g/dL compared to an increase from 8.7 g/dL to 9.4 g/dL on the standard of care.

  • 91% of patients on Empaveli were transfusion-free compared to 22% on the standard of care.

  • On the safety front, 9% of patients in the Empaveli group experienced a serious adverse event compared to 17% on the standard of care.

  • One death was reported in each group, and neither was related to treatment.

  • Detailed results from the PRINCE study will be presented at medical congresses.

  • Empaveli is approved in the U.S. for PNH, a rare blood disorder characterized by the destruction of oxygen-carrying red blood cells through extravascular and intravascular hemolysis.

  • Price Action: APLS shares are trading higher by 9.75% at $51.80 in the premarket session on the last check Tuesday.

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