Syntara Ltd (ASX:SNT, OTC:PMXSF), formerly Pharmaxis Ltd, has dosed the first patient in a phase two clinical trial assessing its pan-LOX inhibitor SNT-5505 in combination with kinase inhibitor ruxolitinib in patients with bone marrow cancer myelofibrosis.
The first phase of trials demonstrated an “excellent safety profile and encouraging signs of efficacy when used in patients who had failed on current standard of care.”
The company expects to complete recruitment for this cohort of patients in the first half of 2024.
Potential to fulfil unmet needs
Syntara recently showcased data from the first cohort of MF-101 where SNT-5505 was used for six months in patients as a monotherapy at the American Society of Hematology’s (ASH) annual meeting in San Diego.
“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,” Harvard Medical School & clinical director, Leukaemia, Massachusetts General Hospital, Medicine, Assistant Professor Dr Gabriela Hobbs said.
“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.”
Phase 2 to support strategic discussions
SNT-5505 is a pan-LOX inhibitor that has also 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.
Syntara believes an effective pan-LOX inhibitor for myelofibrosis would open a market valued at US$1 billion per year.
“This study that commenced recruitment today is crucial in establishing the place for SNT-5505 in the treatment regimen of myelofibrosis patients,” Syntara CEO Gray Phillips said.
“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.”