Novartis has licensed INC424 from Incyte for development and commercialisation outside the US, while the rights for the development and commercialisation of INC424 in the US are retained by Incyte.
INC424 has received orphan drug status for myelofibrosis from both US Food and Drug Administration and the European Medicines Agency.
Results from Phase I/II study evaluating myelofibrosis patients receiving INC424 twice-daily demonstrated rapid reduction in spleen size, which was durable for more than one year of follow-up.
After only one month of therapy, patients with debilitating symptoms including fatigue, night sweats and pruritus (itching) also achieved more than 50% improvement in symptom scores, as measured by the Myelofibrosis Symptom Assessment Form.
Additionally, patients with weight loss, experienced a clinically meaningful gain in total body weight following treatment.
INC424 Phase I/II study showed other clinical benefits such as improved functional status and increased exercise capacity.
Novartis stated that two Phase III clinical trials, Comfort-I in the US, Canada and Australia, and Comfort-II in Europe, have completed recruitment and are evaluating the benefits of treatment with INC424 compared to either placebo or best available care.