Clinical stage drug development company Syntara Limited (ASX: SNT) has confirmed that University Medical Centre Mannheim (UMM) at Heidelberg University in Germany will lead a Phase 1b/2 clinical trial investigating the efficacy of Syntara’s lead asset, SNT-5505, in high-risk MDS patients.
The clinical study follows a long-term pre-clinical research collaboration between Syntara and Medical Faculty Mannheim at Heidelberg University. Under the guidance of Professor Wolf-Karsten Hofmann and Professor Daniel Nowak, the collaboration resulted in a Nature Communications publication1 in 2023 that demonstrated a doubling of response rate to standard therapy when combined with pan-LOX inhibitor SNT-5505.
The AZALOX study in patients with high-risk MDS and CMML will commence in Q1 2025, complementing the previously announced Australian Phase 1c/2 study in low/intermediate risk MDS patients, set to begin in Q4 2024. Seven specialist centres in Germany have already agreed to participate in the study, which has been prioritised by the German MDS Study Group.
The Phase 2 trials in myelofibrosis and MDS present a combined market opportunity for Syntara and its lead SNT-5505 asset of approximately US$6 billion.
The AZALOX study will begin with a dose-escalation phase where two doses of SNT-5505 will be administered to a maximum of 12 patients over six months, in combination with the hypomethylating drug 5-azacytidine (5-AZA). This will be followed by an expansion phase, where 30 patients will receive the selected dose of SNT-5505 and 5-AZA for six months.
"We are eager to further explore the potential of SNT- 5505 in addressing significant unmet needs in the treatment of MDS. The interest amongst academic clinical researchers is a direct response and validation of our long- term collaboration with Heidelberg University,” Syntara CEO, Gary Phillips, said.
“By expanding our clinical trials to include both high-risk and low/intermediate risk MDS patients, we are positioning SNT-5505 as a potential treatment option for all MDS patients. This indication adds both clinical and commercial value to SNT-5505 where our ongoing myelofibrosis study is already fully recruited and will report interim data later this year."
MDS comprises a group of blood cancers with clinical and pathological features similar to acute myeloid leukemia (AML). These conditions are most common in older adults, with an annual incidence of up to 75 cases per 100,000. The current standard of care for high-risk MDS includes treatment with hypomethylating agents (HMAs) like 5-AZA and decitabine.
Although approximately 50% of MDS patients initially respond to HMAs, subsequent relapse is common, highlighting the urgent need for new compounds that enhance the efficacy of existing treatments.
Heidelberg University has received a German Cancer Aid grant of $2.5m to cover the costs of the study and Syntara will provide trial supplies of SNT-5505.