Syntara advances myelofibrosis trial with Phase 2 data and SNT-5505 FDA fast track designation
Clinical-stage drug developer Syntara (ASX: SNT) has hit more milestones with its SNT-5505 blood cancer treatment candidate.
The company informed shareholders that it has obtained further positive interim data from its ongoing Phase 2 clinical trial evaluating SNT-5505 in combination with ruxolitinib (RUX) for the treatment of myelofibrosis.
Myelofibrosis is a type of blood cancer where fibrous scar tissue replaces the bone marrow and disrupts the production of healthy blood cells, potentially leading to anaemia, bleeding problems and an increased risk of infection.
Fast track designation
Receipt of the new trial data comes just days after the US Food and Drug Administration (FDA) granted Syntara fast track designation for SNT-5505.
The highly sought-after designation enables more frequent FDA interaction, eligibility for priority review and discussions on accelerated approval.
Syntara said the latest interim results further highlight the safety and clinical benefits of SNT-5505’s unique mechanism of action and competitive profile in treating myelofibrosis patients who have had a suboptimal response to existing standard of care.
Three-year treatment
Syntara treated patients who showed symptom scores, spleen sizes and blood counts indicative of high disease burden with RUX in the trial for an average of three years.
Syntara noted that continued improvement in patient symptoms and spleen volume was a novel finding that differentiates SNT-5505 from myelofibrosis drugs currently on the market or in later stages of development.
“It highlights the potential of SNT-5505 to be used in combination with Janus kinase inhibitors to change the long-term outcomes for MF patients,” the company stated.
Final results imminent
Syntara said it expected the remaining three patients in the study to complete 12 months of treatment in Q3 2025, after which it will report the final study results.
The company then intends to engage in discussions with the FDA regarding the study results and a trial design for a pivotal Phase 2c/3 study.
At the same time, the company plans to continue its discussions with potential partners both globally and regionally.