French drugmaker Sanofi (SNY, SNYNF.PK) Friday announced that the Phase III study of Myelofibrosis inhibitor SAR302503 recorded greater 35 percent reduction in spleen volume, conforming its primary endpoint in both dose groups. The pivotal study named JAKARTA examined the selective JAK2 inhibitor and is consistant with its earlier trials.
The company is planning regulatory filings with authorities to make the medicine available for patients.
Myelofibrosis or MF is a rare, debilitating and life-threatening hematologic malignancy, resulting in an abnormal blood cell production and scarring, or fibrosis, in bone marrow.
Sanofi Oncology is developing SAR302503 for the treatment of three main types of myeloproliferative neoplasms: primary myelofibrosis, including those previously treated with ruxolitinib; polycythemia vera; and essential thrombocythemia that result in higher platelet count.
"Patients with myelofibrosis in advanced stages are desperately ill and in need of treatments that will improve their outcomes," said Debasish Roychowdhury, senior vice president and head, Sanofi Oncology.
The randomized, double-blind, placebo-controlled Phase III JAKARTA study was conducted in 24 countries, which evaluated once-daily oral SAR302503. The investigational drug was compared to placebo in 289 patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.
Sanofi noted that it is also studying the effect of the compound on reversing fibrosis in the bone marrow.
The company said the most common adverse events were anemia, diarrhea, nausea and vomiting, which are consistent with data reported in previous trials.
Sanofi said it will present the full results at an upcoming medical congress.
In Paris, Sanofi shares are currently trading at 84.40 euros, down 0.26 percent, on a volume of 3.69 million shares. SNY closed Thursday's regular trading at $54.21 on the NYSE.
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