On April 9, 2024 Syntara Limited (ASX: SNT) reported that it has reached the 50% recruitment milestone in its Phase 2 trial evaluating SNT-5505, in combination with ruxolitinib, treating the bone marrow cancer myelofibrosis (Press release, Syntara, APR 9, 2024, View Source [SID1234641950]).
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Recruitment for the open-label study commenced in December 2023 with the 8th patient in the 15-patient trial dosed earlier this week, keeping Syntara on track for completion of recruitment by the end of H1 2024.
The trial is being conducted across 19 clinical trial sites in the USA, Australia, South Korea and Taiwan. SNT-5505 is a pan-LOX inhibitor and the lead asset in Syntara’s drug discovery pipeline.
Syntara anticipates reporting on 6-month results of the trial in an interim data update at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2024. The interim data is expected to allow Syntara to engage with and discuss pivotal study design with the FDA in Q1 2025, with the full 12-month data set to be available by mid-2025.
Syntara commenced the combination trial after it found encouraging efficacy and an excellent safety profile in a Phase 2 monotherapy trial of the drug, as presented at ASH (Free ASH Whitepaper) in December 2023. An effective pan-LOX inhibitor, such as SNT-5505, for myelofibrosis has Syntara’s lead asset SNT-5505 reaches 50% recruitment in Phase 2 trial; interim results expected December 2024 2 disease modifying potential for patients and would unlock a market conservatively estimated to be more than $1 billion per annum.
Syntara CEO Gary Phillips said: "We’re very pleased with the progression of recruitment in this trial as we observe the impact SNT-5505 can have in combination with the approved standard of care ruxolitinib. In addition to providing us with an opportunity to discuss a pivotal registration study with the FDA, positive developments in the trial will provide Syntara with a platform to engage with potential partners that would be complementary to our efforts to commercialise the drug."
This combination cohort of the Phase 2 MF-101 trial aims to demonstrate that SNT-5505 is safe and effective in myelofibrosis patients who are sub optimally controlled on the market leading JAK inhibitor, ruxolitinib.
SNT-5505 has previously demonstrated compelling pre-clinical data when used in combination with standard of care in other haematological malignancies such as myelodysplastic syndrome and solid tumours like those found in hepatocellular carcinoma and pancreatic cancer.