Australian clinical-stage drug development company Syntara (ASX:SNT) has announced a new Phase 2 trial evaluating the combination treatment of its SNT-5505 with chemotherapy in patients with low and intermediate-risk myelodysplastic syndrome.
Myelodysplastic syndrome (MDS) is a form of blood cancer. The overall five-year survival rate for transfusion-dependent MDS is 37 per cent.
SNT-5505, previously called PXS-5505, is a pan-LOX inhibitor that is Syntara’s lead asset.
Associate Professor Anoop Enjeti will lead the new trial at the University of Newcastle. It will be conducted under the Australasian Leukaemia and Lymphoma Group (ALLG) clinical trial framework. It is the leading investigator-run national blood cancer trials network with more than 160 trials undertaken.
The trial will feature a dose escalation phase where up to nine MDS patients who are transfusion dependent will be treated with a fixed dose of SNT-5505 and two different doses of a hypomethylating agent followed by a dose expansion phase where 30 patients will be treated for six months on the dose combination selected in the first phase based on tolerability and efficacy.
Syntara said endpoints will include reduced transfusion dependency, haematological parameters and quality of life. Results from the dose escalation phase, including safety and preliminary efficacy endpoints, are anticipated by mid-2025. Blood cancers are on the rise and now represent the second most common cause of cancer-related deaths in Australia. Myelodysplastic syndromes are a significant subset of these blood cancers where abnormal tissue growth leads to bone marrow failure, often featuring low blood counts leading to infections, transfusion dependence and risk of progression to acute myeloid leukemia (AML), a more aggressive form of blood cancer.
Syntara CEO Gary Phillips said, “The grant from the MRFF [Medical Research Future Fund] and the support of University of Newcastle and the ALLG enables us to expand the haematology indications for SNT-5505 beyond the current international myelofibrosis study and into another area of high unmet need and commercial value. The possibility of seeing safety and efficacy data in this additional indication in the same time frame as the other phase 2 studies in MF, neurodegenerative disease and burn scars is a win for the company and its shareholders and will generate significant interest in SNT-5505 amongst companies with a focus on haematology.”
