On July 31, 2024 Clinical stage drug development company Syntara Limited (ASX: SNT) reported that it has completed full recruitment in its Phase 2 trial evaluating SNT-5055, in combination with ruxolitinib, treating the bone marrow cancer myelofibrosis (Press release, Syntara, JUL 31, 2024, View Source;v=70bc033a22188bdfefb8a0b8ad3c24897ef2837d [SID1234645175]).
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After commencement of the open-label study in December 2023, Syntara has reached the milestone with the 15ᵗʰ patient dosed yesterday and has already exceeded the minimum threshold of one month treatment for 12 patients proposed in FDA discussions for safety evaluation.
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 proprietary clinical pipeline.
Syntara expects to report interim results from the trial in late 2024, in conjunction with the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. In line with the excellent safety profile observed in earlier phase 1 and phase 2 studies, no drug related dropouts nor any serious adverse reactions have been observed to date.
The reassuring safety profile, alongside 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 12month data set to be available in Q3 2025.
Syntara CEO Gary Phillips said:
"I’d like to thank the haematology clinics, investigators and the Syntara clinical team for achieving this significant milestone in such a timely fashion. We now look forward to presenting our interim data later in the year and building a solid foundation for the next stage of discussions with the FDA and potential strategic partners."
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 disease modifying potential for patients and would unlock a market conservatively estimated to be more than $1 billion per annum.
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.