Novartis reports positive Phase II SUSTAIN study results of SEG101 to treat SCPC
Novartis has reported positive data from its Phase II SUSTAIN study of SEG101 (crizanlizumab) to treat sickle-cell-related pain crises (SCPC).
Formerly known as SelG1, SEG101 is a humanised, anti-P-selectin monoclonal antibody that binds a molecule called P-selectin on the surface of endothelial cells and platelets in the blood vessels, blocking P-selectin.
The blocking of P-selectin can result in the prevention of painful vaso-occlusion in small blood vessels and maintain blood flow.
University of North Carolina division of hematology / oncology Kenneth Ataga said: "Acute painful episodes, commonly referred to as vaso-occlusive crises, are a substantial cause of morbidity in sickle cell disease with limited treatment options."
The multicentre, multinational, randomised, placebo-controlled, double-blind, 12-month SUSTAIN trial was conducted to test the safety and efficacy of SEG101 in treating sickle-cell disease patients with sickle-cell-related pain crises with or without hydroxyurea therapy.
During the study, patients received high-dose and low-dose SEG101, as well as placebo.
Results suggested that the study met its primary endpoint of reduction of the annual rate of SCPC.
Patients experienced a 45.3% reduction of SCPC in the high-dose arm compared to placebo, while in the low dosage arm, the annual rate of SCPC was reduced by 32.6% compared to placebo.
Novartis oncology CEO Bruno Strigini said: "Patients have long been in need of a new therapy for treatment of SCPC, the most common and debilitating complication of sickle-cell disease.
"We are pleased that data from the SUSTAIN study show SEG101 may have the potential to become the first new option for patients dealing with SCPC since hydroxyurea was approved for use in sickle-cell anemia about 20 years ago."