Syntara Limited has received Fast Track designation from the US Food and Drug Administration for its lead candidate SNT-5505, targeting myelofibrosis patients who have shown inadequate response to JAK inhibitor therapy. The regulatory milestone positions the company to accelerate development of what could become a new standard of care for this rare and severe blood cancer.
Novel Mechanism Addresses Treatment Gaps
SNT-5505 represents a distinct therapeutic approach by inhibiting lysyl oxidases, key enzymes involved in fibrosis and growth factor signalling pathways. This mechanism differs from current standard treatments, primarily JAK inhibitors, which are often associated with significant side effects leading to high discontinuation rates among patients.
The FDA awards Fast Track designation after reviewing data demonstrating potential benefit, mechanistic rationale for efficacy, and early clinical evidence. The designation aims to expedite review and development of therapies addressing severe conditions and unmet medical needs, facilitating earlier drug approval and patient access.
Significant Patient Population and Unmet Need
Myelofibrosis affects approximately 15 per one million people worldwide, with about 20,000 patients in the United States. This rare and severe type of bone marrow cancer presents substantial treatment challenges, particularly for patients who do not respond adequately to existing JAK inhibitor therapies.
Clinical studies have demonstrated that SNT-5505 improves patient quality of life with an excellent safety and tolerability profile. The drug is currently undergoing a Phase 2 clinical trial, with additional interim data scheduled for presentation at the European Hematology Association meeting on June 14, 2025.
Regulatory Advantages and Development Timeline
The Fast Track designation provides Syntara with several regulatory advantages, including more frequent FDA interactions, eligibility for Priority Review and Accelerated Approval, and potential Rolling Review support for a New Drug Application. These benefits could significantly reduce the timeline from development to market approval.
"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," said Gary Phillips, Chief Executive Officer of 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."
