On June 13, 2025 Syntara Limited (ASX:SNT), a clinical-stage drug development company, reported 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) (Press release, Syntara, JUN 13, 2025, View Source;v=04711220c3a57065317ba4efca4a3459a4e46882 [SID1234653852]). This data will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Conference on Sunday 15 June 2025 AEST, and builds upon the positive interim results announced at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2024.
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The latest interim results further highlight the safety and clinical benefits of SNT5505’s unique mechanism of action and competitive profile in treating MF patients who have had a suboptimal response to existing standard of care.
Patients in the trial had been treated with ruxolitinib (RUX) for an average of three years with symptom scores, spleen sizes and blood counts indicative of high disease burden.
Highlights:
73% (8/11) of evaluable patients achieved TSS50 at 24 weeks of treatment or beyond.
44% (4/9) of evaluable patients achieved a spleen volume reduction (SVR) of 25% at Week 24 or beyond. Notably there were no increases in dosage of concomitant RUX that might otherwise explain the impact of SNT-5505 on spleen volume.
The continued improvement in patient symptoms and spleen volume is a novel finding that differentiates SNT-5505 from MF drugs on market and in later stages of development. It highlights the potential of SNT-5505 to be used in combination with JAK inhibitors to change the long-term outcomes for MF patients.
SNT-5505 is safe and well tolerated, with no treatment related serious adverse events (SAEs) attributed to SNT-5505; providing additional and important differentiation to MF drugs on market and in development.
Syntara to engage with the FDA in Q3 on study results and trial design for a pivotal Phase 2c/3 study.
Syntara CEO Gary Phillips commented: "After very recently being awarded Fast Track designation, the positive interim data to be presented at EHA (Free EHA Whitepaper) 2025 further reinforces the promising profile of SNT5505 as an add-on therapy for myelofibrosis patients with a suboptimal response to existing standard of care. The sustained and increasing improvements in both symptom burden and spleen volume, coupled with its excellent safety and tolerability, continue to differentiate SNT-5505 from other drugs in this space. We are particularly encouraged by the durability of the responses observed and look forward to reporting final study results and engaging with the FDA and potential partners in the coming months."