Syntara Ltd (ASX:SNT) has hit another milestone in the clinical development of its lead asset SNT-5505, achieving 50% recruitment of patients for a Phase 2 trial evaluating SNT-5505, in combination with JAK inhibitor ruxolitinib, treating the bone marrow cancer myelofibrosis.
The eighth patient in the 15-patient trial was dosed earlier this week, in keeping with the company’s schedule with recruitment expected to be complete by the end of the first half of the year.
Syntara expects to report its six-month interim results at the American Society of Hematology (ASH) Annual Meeting and Exposition in December, which will inform study design with the FDA moving forward – the full 12-month data set will be available in mid-2025.
Toward commercialisation
“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,” Syntara CEO Gary Phillips said.
“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.”
SNT-5505 is the lead asset in Syntara’s drug discovery pipeline. SNT-5505 is an orally taken drug that inhibits the lysyl oxidase family of enzymes, two members LOX and LOXL2 are strongly upregulated in human myelofibrosis.
In pre-clinical models of myelofibrosis PXS-5505 reversed the bone marrow fibrosis that drives morbidity and mortality in myelofibrosis and reduced many of the abnormalities associated with this disease. It has already received investigational new drug (IND) approval and Orphan Drug Designation from the FDA.
The company has already reported encouraging efficacy and an excellent safety profile of SNT-5505 in a monotherapy trial and now seeks to understand how its LOX inhibitor can work in concert alongside the current standard of care, JAK inhibitors.
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.
Syntara believes that “an effective pan-LOX inhibitor – such as SNT-5505 – for myelofibrosis has disease-modifying potential for patients and would unlock a market conservatively estimated to be more than $1 billion per annum”.