- Pegcetacoplan demonstrated statistical superiority on the co-primary endpoints of haemoglobin stabilisation (p<0.0001) and reduction in lactate dehydrogenase (LDH) (p<0.0001) compared to standard of care, which did not include complement inhibitors, at week 26
- Mean haemoglobin levels in the pegcetacoplan 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 standard of care (p=0.0019)
- 91 per cent of patients on pegcetacoplan were transfusion free compared to 22 per cent on standard of care (p<0.0001)
- The safety profile of pegcetacoplan was consistent with previous studies
Pegcetacoplan demonstrated statistical superiority on the co-primary endpoints of haemoglobin stabilization and reduction in lactate dehydrogenase (LDH) compared to standard of care, which did not include complement inhibitors, at week 26.
- 86 per cent of pegcetacoplan treated patients achieved haemoglobin stabilisation compared to 0 per cent of patients on standard of care (p<0.0001). Haemoglobin stabilisation was defined as an avoidance of a >1 g/dL decrease in haemoglobin levels in the absence of transfusions.
- Mean LDH in the pegcetacoplan group decreased by 90 per cent from a baseline of 2151 U/L [9.5x upper limit of normal (ULN)] to 211 U/L, which is within the normal range, compared to a 14 per cent reduction on standard of care from a baseline of 1946 U/L (8.6x ULN) to 1681 U/L (7.4x ULN) (p<0.0001).
"The positive
Pegcetacoplan also achieved statistical superiority on several secondary endpoints, including improvements in haemoglobin levels and transfusion avoidance, compared to standard of care, which did not include complement inhibitors.
- Mean haemoglobin levels in the pegcetacoplan group increased from 9.4 g/dL to 12.1 g/dL compared to an increase from a baseline of 8.7 g/dL to 9.4 g/dL on standard of care (p=0.0019).
- 91 per cent of patients on pegcetacoplan were transfusion free compared to 22 per cent on standard of care (p<0.0001).
The safety profile of pegcetacoplan was consistent with previous studies. At week 26, 9 per cent of patients in the pegcetacoplan group experienced a serious adverse event (SAE) compared to 17 per cent on standard of care. One death was reported in each group, and neither were related to treatment. No cases of meningitis or thrombosis were reported in either group. The most common adverse events reported during the study in the pegcetacoplan and standard of care groups, respectively, were injection site reaction (30 per cent vs. 0 per cent), hypokalemia (13 per cent vs. 11 per cent), and fever (9 per cent vs. 0 per cent).
"The
Detailed results from the
About the
The
About pegcetacoplan
Pegcetacoplan is an investigational therapy targeting C3, the central protein in the complement cascade. It acts proximally in the complement cascade controlling both C3bmediated extravascular haemolysis and terminal complementmediated intravascular haemolysis. Pegcetacoplan is being evaluated in several clinical studies across haematology, ophthalmology, nephrology, and neurology. In
About Paroxysmal Nocturnal Haemoglobinuria (PNH)
PNH is a rare, chronic, life-threatening blood disorder characterized by the destruction of oxygen-carrying red blood cells through extravascular and intravascular haemolysis. Persistently low haemoglobin can result in frequent transfusions and debilitating symptoms such as severe fatigue, haemoglobinuria and difficulty breathing (dyspnea).
About Apellis
About Sobi(TM)
Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology and specialty indications. Today, Sobi employs approximately 1,500 people across
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