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news.Novartis' pivotal Phase III trial of the investigational Janus kinase (JAK) inhibitor INC424 has met its primary endpoint of significantly reducing spleen volume in patients with myelofibrosis (MF).
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The study results revealed that INC424 provided a statistically significant reduction in spleen size in patients with primary MF, post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF).
The study also met its secondary endpoints of symptomatic improvement as measured by the modified Myelofibrosis Symptom Assessment Form Diary.
The safety of profile of INC424 was consistent with previous studies, which included reversible thrombocytopenia and anaemia
The randomised, double-blind, placebo-controlled Phase III enrolled 309 patients with primary MF, PPV-MF or PET-MF, in which half received INC424 and half received placebo.
Novartis has licensed INC424 from Incyte for development and potential commercialisation outside the US, while Incyte has retained rights for the development and potential commercialisation of INC424 in the US.
INC424 has been granted orphan drug status for MF by both US Food and Drug Administration and the European Medicines Agency.