On August 11, 2025 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that it has received feedback from the US Food and Drug Administration (FDA) regarding the next stages of clinical development for amsulostat in myelofibrosis (MF) (Press release, Syntara, AUG 11, 2025, View Source [SID1234655047]).
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During a Type C meeting, the FDA reviewed a comprehensive data package that included interim data (as presented at the European Hematology Association (EHA) (Free EHA Whitepaper) congress in June 2025) from the ongoing open label trial (MF-101) of amsulostat in combination with ruxolitinib, as well as a proposal for a pivotal registrational study.
The FDA has provided guidance that a Phase 2 trial with a control arm be undertaken to acquire additional safety and efficacy data, focussing on improvements in symptoms and spleen volume reductions in order to optimise the design and efficiency of a subsequent pivotal Phase 3 trial.
Syntara CEO Gary Phillips said: "Over the coming period we will use the FDA guidance to refine our clinical development plan for amsulostat and continue discussions with partners based on the FDA recommended path forward. Syntara is in a strong position given the depth and quality of our pipeline and a cash runway that will take us into 2027. We look forward to sharing results from our ongoing clinical trials over the coming months."
Syntara’s updated clinical pipeline development plan is shown in the following table:
Investor Webinar
Syntara will hold an investor webinar following today’s announcement regarding the next stages of clinical development for amsulostat.
CEO Gary Phillips will provide an update and presentation as part of the webinar, to be held at 12 noon AEST Monday 11 August 2025.
Shareholders, investors and interested parties are encouraged to register to attend the presentation at the following link:
After registering, you will receive a confirmation email containing information about joining the webinar as well as dial-in details for those that wish to join by phone.