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.
Friday certainly was a day of excitement 3 x ASX Announcements
Thought it was going to run with the 8m volume on open and the quick climb to 8.3c
Very little promotion last week ,,, Poor would be an understatement
Management must be comfortable ,,maybe to comfortable when they cant be arsed drumming up supportive editorial and investing in Market Message Delivery .
Flattest delivery of Phase II Data I have seen in over a decade ... SNT ??
Well lets see what this week brings from the weekends presentation .. maybe there is some more Editorial or Market Promotion this week to support the epic Phase II Data ?? 5 years and $30m in the development and around $4 bucks spent on increasing SH Value...
