On November 20, 2025 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported the opening of MDS05/D3 MESSAGE, a Phase 2 multi-centre trial investigating amsulostat (SNT-5505) in combination with hypomethylating agent ASTX727 for the treatment of transfusion dependent, low and intermediate risk Myelodysplastic Syndromes (MDS): ALLG | New MDS05 MESSAGE Trial | Transfusion Dependent MDS.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The Principal Investigator, Associate Professor Anoop Enjeti, commented: "One of the inspirations for this study came from some ground breaking pre-clinical work recently conducted by Heidelberg University that showed a significant increase in red blood cell production when the Syntara drug, amsulostat, was added to a hypomethylating agent that is commonly used in high risk MDS patients. Amsulostat has since been shown to be safe and well tolerated when used in patients with another type of haematological cancer, myelofibrosis, for up to 12 months so we are excited about the potential it might hold for patients with MDS who have very few treatment options".
The multi-centre study will open at 10 hospitals across Australia with up to 30 patients to be recruited for treatment. It aims to reduce the reliance on fortnightly blood transfusions typically required by MDS patients, improving the survival outcomes and lessening the treatment burden.
The trial is being led by the Australasian Leukaemia & Lymphoma Group (ALLG), while being funded by the Australian Government’s Medical Research Future Fund, with contributions from Syntara and Taiho as industry partners.
MDS is a form of blood cancer where patient’s bone marrow fails to produce enough healthy blood cells, causing bone marrow failure. This high treatment burden in transfusion dependent MDS greatly impacts both quality of life for patients as well as placing a heavy load on blood transfusion supply.
Patients with this type of MDS also experience far worse outcomes, with a 5-year survival rate of just 37.3%, and a high risk of progression from MDS to acute myeloid leukaemia (AML), an aggressive and often fatal blood cancer.
Associate Professor Anoop Enjeti said: "Transfusion dependent myelodysplasia has no approved treatments currently available for Australian patients. The MDS05 MESSAGE trial’s new treatment combination aims to improve survival rates and quality of life for patients with this type of MDS by reducing the reliance on regular blood transfusions. Another unique aspect will be the combination of 2 oral medications making this trial more accessible to patients."
ALLG Chief Executive Officer, Delaine Smith, said: "The ALLG is the only collaborative blood cancer clinical trial group in Australasia, conducting clinical trials into MDS, AML and other leukaemias, lymphomas and myeloma. Our independent, clinician-led network enables us to conduct research into all areas of blood cancers, including rarer cancers and areas of high unmet need. We’re excited to launch the MESSAGE clinical trial to improve the outcomes and quality of life for transfusion-dependant MDS patients and delighted to work with Syntara whose original research underpins this new treatment concept."
The commencement of this trial follows (see ASX announcement 18 July 2025) the initiation of AZALOX, a Phase 1b/2 multi-centre study in Germany evaluating amsulostat in combination with 5-Azacitidine for the treatment of high-risk Myelodysplastic Neoplasms (MDS) and Chronic Myelomonocytic Leukemia (CMML). Updates on recruitment and interim safety and efficacy data are anticipated as both studies progress in 2026.
Syntara CEO Gary Phillips commented: "The MESSAGE trial allows us an opportunity to prove the potential of amsulostat in another form of blood cancer, complementary to our lead program in myelofibrosis and the AZALOX study in related MDS indications in Germany. We appreciate the support of the ALLG, Taiho, Professor Enjeti in conducting the trial and the financial support from the MRFF. We look forward to seeing initial results from this study in 2026 and, in the longer term, making a difference for these patients with limited treatment options."
(Press release, Syntara, NOV 20, 2025, https://mcusercontent.com/add2e2fa70ec3d0eeaf2a93cc/files/bfd40536-38a4-84f6-6c22-0325db62adbd/03026278.pdf [SID1234660852])