Sanofi today announced that its randomized, double-blind, placebo-controlled Phase III JAKARTA study evaluating its investigational JAK2 kinase inhibitor SAR302503 for myelofibrosis has met its primary endpoint—of patients achieving greater than or equal to 35% reduction of spleen volume—in both dose groups.
“I am pleased with the results of JAKARTA,” Debasish Roychowdhury, M.D., svp and head, Sanofi Oncology, said in a statement. “Since Sanofi's acquisition of the molecule, SAR302503 has moved from Phase I to the completion of pivotal Phase III studies in less than three years, and now we are planning regulatory filings with authorities to make this medicine available for patients,” Dr. Roychowdhury added.
Sanofi acquired the drug candidate in 2010 when it snapped up small molecule drug development firm TargeGen.