Apellis Pharmaceuticals (NASDAQ:APLS) has dosed first patient in the VALIANT Phase 3 clinical study of its drug candidate Pegcetacoplan for primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G), two rare and debilitating kidney diseases with similar underlying causes and no approved treatment.
The VALIANT Phase 3 study is designed to evaluate pegcetacoplan efficacy and safety in approximately 90 patients who are 12 years of age and older with primary IC-MPGN or C3G.
The Phase 3 study advancement is supported by positive Phase 2 results of pegcetacoplan.
Jeffrey Eisele, Ph.D., chief development officer, said, "There is a significant need for treatments for people living with these rare kidney diseases, and we believe pegcetacoplan, by targeting complement centrally at C3, may have the potential to protect kidney function and preserve patient quality of life.”
Apellis Pharma closed Monday's trading down 5 percent at $43.15
