Syntara (ASX:SNT) has announced that its lead candidate, SNT5505, has been granted Fast Track Designation by the US FDA for the treatment of myelofibrosis in patients with an inadequate response to JAK inhibitor therapy.
The FDA can award the designation after reviewing data that demonstrates potential benefit, a mechanistic rationale for efficacy, and early clinical evidence. It aims to expedite the review and development of therapies that address severe conditions and unmet medical needs, facilitating earlier drug approval and patient access.
Myelofibrosis is a rare and severe type of bone marrow cancer affecting approximately 15 per one million people worldwide, with about 20,000 patients in the US. Current standard of care, primarily JAK inhibitors, are often associated with significant side effects, leading to high discontinuation rates.
SNT-5505 represents a novel therapeutic approach by inhibiting lysyl oxidases, key enzymes in fibrosis and growth factor signalling pathways.
Syntara CEO Gary Phillips said, "To have the FDA recognise the quality of the pre-clinical and clinical results generated to date, as well as the therapeutic promise of SNT-5505 through this Fast Track designation, is an outstanding development for Syntara. This supports our efforts to rapidly advance SNT-5505 as a potential new standard of care for patients with myelofibrosis, addressing the noticeable gaps left by existing treatments."