Sanofi’s myelofibrosis drug met its primary endpoint in phase 2

Hannah Blake

pharmaphorum

Sanofi has announced that new phase 2 clinical trial data for JAK2 inhibitor, SAR302503, met its primary endpoint in reducing spleen size and improving constitutional symptoms in patients with intermediate-2 or high-risk primary or secondary myelofibrosis (MF), a hematologic malignancy with unmet medical needs.

Sanofi presented the data during the 2012 Annual Meeting of the American Society of Hematology in Atlanta, Ga., December 8-11, 2012.

“I am very pleased with how much progress has been made in the development of our JAK2 inhibitor. This study confirms the once-daily oral administration of SAR302503 identified for use in the Phase III trial in this difficult-to-treat patient population. We believe SAR302503 could provide a benefit to these patients with primary and secondary myelofibrosis and we look forward to our Phase III results next year.”

Debasish Roychowdhury, M.D., Senior Vice President and Head, Sanofi Oncology.

These phase 2 trial results support the two doses selected for the SAR302503 phase 3 JAKARTA trials that are currently under way. JAKARTA enrolled 289 patients over nine months and initial results are expected in the second quarter of 2013.