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news.Sanofi's selective JAK2 inhibitor (SAR302503) has reduced spleen size and improved constitutional symptoms in Phase II trial conducted in myelofibrosis (MF) patients.
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Patients with intermediate-2 or high-risk primary or secondary MF were involed in open label, randomised dose-ranging study that assessed the once-daily oral doses of 300mg, 400mg, and 500mg of SAR302503.
Sanofi Oncology senior vice president and head Debasish Roychowdhury said the study confirms the once-daily oral administration of SAR302503 identified for use in the Phase III trial in the 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," Roychowdhury added.
Change in spleen volume at the end of cycle three assessed by MRI with independent central review is the primary endpoint of the study while the secondary endpoints consist of spleen response, safety and symptom response using the MPN-SAF scale.
Results support 400mg and 500mg doses selected for the SAR302503 Phase III JAKARTA trial that currently enrolled 289 patients over nine months and expects interim results in the second quarter of 2013.