On July 17, 2025 Syntara Limited (ASX:SNT), a clinical-stage drug development company, reported initiation of AZALOX, a Phase 1b/2 multi-centre study evaluating amsulostat (SNT-5505) in combination with 5-Azacitidine for the treatment of high-risk Myelodysplastic Neoplasms (MDS) and Chronic Myelomonocytic Leukemia (CMML) (Press release, Syntara, JUL 17, 2025, View Source;v=4a466cc3f899e00730cfbfcd5ab8940c41f474b6 [SID1234654426]).
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The study commenced at University Medicine Mannheim (UMM), Germany, the first of nine planned centres expected to enrol patients under the German MDS Study Group. Led by Professor Susanne Saußele and her team, the trial will focus on patients with significant disease severity who are transfusion dependent.
The initial Phase 1b portion of the AZALOX trial will determine the safety profile and recommended dose of amsulostat alongside 5-Azacitidine. The Phase 2 component will then further evaluate safety and efficacy of the selected dose across 30 patients.
Patients eligible for the trial include those with confirmed high-risk MDS or CMML, who are either treatment-naïve or have undergone limited prior treatment with hypomethylating agents.
The trial is financially supported by German Cancer Aid (Deutsche Krebshilfe, DKH), with Heidelberg University sponsoring the study in collaboration with the Coordination Centre for Clinical Studies (KKS) Heidelberg.
Professor Saußele commented: "Our preclinical data suggest that with this combination therapy, we can reactivate the production of red blood cells. With this, we aim to eliminate the need for blood transfusions in the long term and reduce the risk of transformation to acute myeloid leukemia."
Syntara CEO, Gary Phillips stated: "We are delighted to be working with the German MDS Study Group as they initiate the AZALOX study. This represents an important milestone for amsulostat, leveraging the positive results in myelofibrosis and expanding to a second blood cancer indication. The AZALOX trial builds on promising preclinical data, potentially providing a new treatment option for patients suffering from MDS and CMML."