Syntara (ASX:SNT) said a phase 1b/2 multi-center study evaluating its amsulostat drug candidate in combination with standard therapy 5-Azacitidine for the potential treatment of high-risk myelodysplastic neoplasms as well as chronic myelomonocytic leukemia was initiated with the University Medicine Mannheim in Germany as the first active study center, according to a Friday Australian bourse filing.
The initial phase 1b trial will determine the safety profile and recommended dose of amsulostat alongside 5-Azacitidine, while the second phase component will further evaluate the safety and efficacy of the selected dose across 30 patients.
The trial will also seek to determine the candidate's ability to improve overall response as well as progression-free, event-free, and overall survival, per the filing. It will also evaluate the quality of life, pharmacokinetics, and pharmacodynamics.
Confirmed high-risk myelodysplastic neoplasms or chronic myelomonocytic leukemia patients who are either treatment-naïve or have undergone limited prior treatment with hypomethylating agents are eligible for the trial.
Nine planned centers are expected to enroll patients under the German MDS study group, the filing said.
The firm's shares rose almost 2% in recent trading on Friday.