Syntara (ASX:SNT) has announced that the AZALOX clinical trial has completed its first dose escalation cohort and will advance to the final Phase 1b cohort after an independent Drug Safety Monitoring Board approved dose escalation to amsulostat 200 mg twice daily in combination with 5‑Azacitidine.
The study was initiated following encouraging preclinical research indicating that the combination of amsulostat and a hypomethylating agent may reactivate red blood cell and platelet production. The ongoing clinical study is assessing whether this approach may reduce patients’ dependence on blood transfusions and lower the risk of disease progression to acute myeloid leukaemia.
The initial cohort tested amsulostat at 150 mg twice daily and reported no dose-limiting toxicities and no new adverse events attributable to the drug.
The move to the higher dose follows a safety review and comes as all ten participating clinical sites in Germany have been initiated and opened for recruitment.
Sites are actively pre-screening potential participants, and several patients are already pre-registered for the 200 mg cohort.
Syntara expects preliminary Phase 1b data during the fourth quarter of 2026 and, subject to safety review, plans for the study to progress to a Phase 2 component designed to evaluate safety and efficacy in about thirty patients.
Syntara Chief Executive Officer Gary Phillips said, “Completion of the first AZALOX cohort without any dose-limiting toxicities and clearance to progress to the 200 mg dose represents an important step forward for the amsulostat program. With 10 German centres now open and patients already pre-registered for the final dose cohort, the study is well positioned to generate preliminary Phase 1b data during the fourth quarter of 2026. High-risk MDS represents a significant potential indication expansion and commercial opportunity for amsulostat beyond the FDA-supported development pathway in myelofibrosis. Together with the Australian MESSAGE study in lower‑risk disease, AZALOX provides the opportunity to evaluate amsulostat across distinct MDS populations and build a broader clinical data package around the asset.”
AZALOX is being run through the German MDS Study Group under the sponsorship of Heidelberg University and is financially supported by German Cancer Aid. The trial tests whether combining amsulostat with a hypomethylating agent can reactivate red blood cell and platelet production, reduce transfusion dependence, and lower the risk of progression to acute myeloid leukaemia.
