Cytopia Lodges IND for JAK2 Inhibitor CYT387

Cytopia Ltd announced today that it has filed an Investigational New Drug Application (IND) with the US Food and Drug Administration (FDA) for its novel, potent orally active JAK2 inhibitor CYT387.

Following FDA review, the company intends to commence a Phase I/II trial for CYT387 in patients with myelofibrosis, a serious progressive and chronic condition where scar tissue develops in the bone marrow. CYT387 is expected to be the second Cytopia developed drug candidate in clinical studies and the first trialled in the United States, with the anticancer .

vascular disrupting agent CYT997 now in Phase II clinical studies in Australia.

Over-activity of the JAK2 enzyme is implicated in a variety of haematological conditions known as the myeloproliferative disorders (MPDs). This suite of conditions includes myelofibrosis, polycythemia vera and essential thrombocythemia. Cytopia has demonstrated that CYT387 inhibits the overactive JAK2 enzyme in an invivo preclinical model and in cells from patients with MPDs. This data suggests that the compound may exert a profound effect on the human disease.

Myelofibrosis results in a compromised ability of patients to produce sufficient blood cells and a reliance on organs other than the bone marrow, including the liver and spleen, to produce cells. Typical symptoms include an enlarged spleen and progressive anemia and poor overall survival.

"The filing of an IND for CYT387 is the culmination of a comprehensive preclinical development effort by the Cytopia Drug Development team," said Mr Andrew Macdonald, CEO of Cytopia. "Our deep knowledge of the JAK2 target has been integral to the design of this drug and the program is significantly bolstered by the intellectual property we hold over the JAK2 target."

The clinical utility of CYT387 is also expected to have broader applicability in diseases driven by disregulated JAK2 signalling, including some cancers and various inflammatory conditions. Cytopia is exploring the utility of CYT387 in these conditions.

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