French drugmaker Sanofi (SNY, SNYNF.PK) announced that the pivotal study, JAKARTA, examining the selective JAK2 inhibitor SAR302503 for myelofibrosis or MF, met its primary endpoint in both dose groups.
Conducted in 24 countries, the randomized, double-blind, placebo-controlled Phase III JAKARTA study evaluated once-daily oral SAR302503 versus placebo in 289 patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemiaMyelofibrosis.
The primary endpoint was the proportion of patients with a reduction in spleen volume >35% after 24 weeks of treatment. Key secondary endpoints include the assessment of associated symptoms as measured by total symptom score using six key symptoms as measured by the modified Myelofibrosis Symptom Assessment Form diary.
Sanofi said it is also studying the effect of the compound on reversing fibrosis in the bone marrow. After the completion of 24 weeks of treatment or disease progression, crossover from the placebo arm to SAR302503 was allowed.
Consistent with data reported in previous trials, the most common adverse events were anemia, diarrhea, nausea and vomiting.
The company said it will present full results at an upcoming medical congress.
Myelofibrosis is a rare, but serious blood disease characterized by abnormal blood cell production and fibrosis (scarring) within the bone marrow. Scarring in the bone marrow interferes with blood cell production, and the spleen and liver compensate by producing and storing extra blood cells, which cause an enlarged spleen.
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