Guidance from FDA on amsulostat clinical progression
| Stock | Syntara Ltd (SNT.ASX) |
|---|---|
| Release Time | 11 Aug 2025, 9:49 a.m. |
| Price Sensitive | Yes |
Syntara receives FDA guidance on amsulostat clinical progression
- FDA provided guidance on next stages of clinical development for amsulostat in myelofibrosis
- Phase 2 trial with control arm to be undertaken to acquire additional safety and efficacy data
- Syntara's updated clinical pipeline includes upcoming milestones across multiple drug candidates
Syntara Limited, a clinical-stage drug development company, has received feedback from the US Food and Drug Administration (FDA) regarding the next stages of clinical development for amsulostat in myelofibrosis (MF). During a Type C meeting, the FDA reviewed a comprehensive data package that included interim data 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's CEO, Gary Phillips, stated that the company will use the FDA guidance to refine its clinical development plan for amsulostat and continue discussions with partners based on the recommended path forward. Syntara is in a strong position with a depth and quality pipeline and a cash runway that will take the company into 2027. The company looks forward to sharing results from its ongoing clinical trials over the coming months.
Syntara provided an updated clinical pipeline development plan, which includes the following high-importance, price-sensitive forward-looking information: - Amsulostat (myelofibrosis): Top line 12-month data expected Q3 2025 - Amsulostat (myelodysplastic syndrome): Interim data expected H1 2026 - SNT-9465 (hypertrophic scars): Data expected H1 2026 - SNT-6302 (keloid scars): Data expected H2 2026 - SNT-4728 (IRBD and Parkinson's Disease): Data expected H1 2026
Syntara is in a strong position given the depth and quality of its pipeline and a cash runway that will take the company into 2027. The company looks forward to sharing results from its ongoing clinical trials over the coming months.