New positive interim data in Phase 2 study of SNT-5505

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Stock Syntara Ltd (SNT.ASX)
Release Time 13 Jun 2025, 8:36 a.m.
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 Syntara announces positive interim data in Phase 2 study of SNT-5505
Key Points
  • 73% of evaluable patients achieved TSS50 at 24 weeks or beyond
  • 44% of evaluable patients achieved spleen volume reduction of 25% at Week 24 or beyond
  • SNT-5505 was safe and well tolerated with no treatment-related serious adverse events
Full Summary

Syntara Ltd, a clinical-stage drug development company, announced further positive interim data from its ongoing Phase 2 clinical trial evaluating SNT-5505 (200 mg BID) in combination with ruxolitinib (RUX) for the treatment of myelofibrosis (MF). The latest interim results build upon the positive interim results announced at the American Society of Hematology (ASH) Annual Meeting in December 2024, and will be presented at the European Hematology Association (EHA) Conference on Sunday 15 June 2025. The data highlights the safety and clinical benefits of SNT-5505's unique mechanism of action and competitive profile in treating MF patients who have had a suboptimal response to existing standard of care. Key points from the latest interim data include: good safety and tolerability, with no treatment-related serious adverse events attributed to SNT-5505; 73% of evaluable patients achieving TSS50 (≥50% reduction in Myelofibrosis Symptom Assessment Form Total Symptom Score) at Week 24 or beyond; 44% of evaluable patients achieving a spleen volume reduction (SVR) of 25% or more at Week 24 or beyond; and generally stable hemoglobin levels and platelet counts across the cohort. Syntara will engage with the FDA in Q3 regarding the study results and trial design for a pivotal Phase 2c/3 study, while continuing discussions with potential global and regional partners.

Outlook

Syntara will engage with the FDA in Q3 regarding the study results and trial design for a pivotal Phase 2c/3 study of SNT-5505 in myelofibrosis, and continue discussions with potential global and regional partners.