S*BIO's JAK2 inhibitor SB1518 granted orphan status by European Commission for myelofibrosis

Privately-held Singapore-based S*BIO Pte says that the European Commission has granted orphan drug designation to SB1518, its potent and orally active JAK2 inhibitor for the treatment of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF). SB1518 has also received orphan designation from the US Food and Drug Administration (FDA) for the treatment of the same disorder.

S*BIO recently reported positive safety and tolerability data from an Australian Phase I study in 20 patients treated with SB1518. Results were consistent with the data from SB1518's US Phase I trials in which safety, tolerability and activity in different disease states had been observed. S*BIO is currently in Phase II MF trials with SB1518, to further test its safety and efficacy.

Unmet need for MF treatment in Europe and elsewhere