Clinical-stage drug development company Syntara (ASX:SNT), formerly Pharmaxis, has commenced dosing in the final cohort of a phase 2 clinical trial studying its pan-LOX inhibitor SNT-5505 in patients with myelofibrosis.
The company said the trial was cleared to progress after an FDA review of the protocol and data from the earlier cohort, demonstrating a positive safety profile and encouraging signs of efficacy when used in patients who had failed on the current standard of care.
This additional cohort of the phase 2 trial MF-101 aims to demonstrate that SNT-5505, the lead asset in Syntara’s drug discovery pipeline, is safe and effective in myelofibrosis patients who are suboptimally controlled on Novartis' PBS-listed JAK inhibitor JAKAVI (ruxolitinib).
The company said full recruitment of 15 patients is targeted for the second quarter of 2024 from 19 clinical trial sites in Australia, South Korea, Taiwan and the US. The open-label study is expected to report interim data on six months of treatment in late 2024 and final data from 12 months in mid-2025.
Data previously announced by the company from the first cohort of MF-101, where SNT-5505 was used for six months in patients as a monotherapy, was presented this week at the American Society of Haematology (ASH) 2023 meeting in San Diego.
According to Dr Gabriela Hobbs, Assistant Professor of Medicine at Harvard Medical School, “The data presented this week at ASH demonstrated that when used as a monotherapy in patients who have failed on a JAK inhibitor, SNT-5505 comprehensively inhibits the LOX enzymes, is well tolerated, and in some patients led to improvements in fibrosis and blood counts, which are encouraging signs of efficacy. Treatments like SNT-5505 that are well tolerated and can improve/stabilize blood counts and fibrosis are needed. In particular, SNT-5505 in combination with JAK inhibitor therapy has the potential to enhance the impact of JAK inhibitor treatment on symptoms, which is a vital area for future research. I eagerly anticipate reviewing data from this next study cohort in 2024.”
Syntara CEO Gary Phillips said, “This study that commenced recruitment today is crucial in establishing the place for SNT-5505 in the treatment regimen of myelofibrosis patients. The open label design enables us to assess the performance of SNT-5505 in real time and we are targeting a major interim data update at ASH 2024 that will also trigger follow up discussions with the FDA on the pivotal registration study design and support ongoing discussions with strategic partners.”