Syntara Faces Uncertainty Over Payments Amid Clinical Advances
Syntara Limited reports encouraging Phase 2 data for its lead drug amsulostat in myelofibrosis, secures FDA Fast Track status, and expands clinical programs into myelodysplastic syndrome and keloid scars.
- Positive interim Phase 2 data for amsulostat in myelofibrosis
- FDA grants Fast Track designation for amsulostat
- Phase 1b/2 trial initiated for amsulostat in myelodysplastic syndrome
- First patient dosed in Phase 1c trial for keloid scars
- Strong cash position of $15.1 million at quarter end
Clinical Progress Bolsters Syntara’s Pipeline
Syntara Limited (ASX – SNT), a clinical-stage biotech focused on extracellular matrix dysfunction, has delivered a robust quarter marked by significant clinical and regulatory milestones. The company’s lead candidate, amsulostat (SNT-5505), continues to demonstrate promising results in treating myelofibrosis (MF), a rare bone marrow cancer characterised by scar tissue buildup that impairs blood cell production.
In June, Syntara presented positive interim data from its ongoing Phase 2 trial combining amsulostat with the JAK inhibitor ruxolitinib. The data, showcased at the European Hematology Association conference, revealed that 73% of evaluable patients achieved at least a 50% reduction in symptom scores after 24 weeks, with sustained improvements up to 52 weeks. Additionally, nearly half of the patients experienced meaningful spleen volume reductions, a key clinical endpoint in MF. Importantly, the treatment was well tolerated, with no serious adverse events attributed to amsulostat.
Regulatory Recognition and Expanded Indications
Building on these encouraging clinical results, the US Food and Drug Administration granted Fast Track designation to amsulostat for MF patients who have inadequate responses to existing JAK inhibitors. This status accelerates the regulatory pathway, facilitating more frequent FDA interactions and potential priority reviews, which could shorten time to market if further trials confirm efficacy.
Beyond MF, Syntara has broadened amsulostat’s development into myelodysplastic syndrome (MDS), a related blood cancer with limited treatment options. A Phase 1b/2 trial recently commenced in Germany, supported by German Cancer Aid and Heidelberg University, to evaluate safety and efficacy in combination with 5-Azacitidine. Another MDS study is planned in Australia, underscoring the company’s strategic push into hematological malignancies.
Diversifying with Novel Scar Treatment and Neurodegenerative Research
In parallel, Syntara has initiated a Phase 1c trial for its topical lysyl oxidase inhibitor SNT-6302 targeting keloid scars, a disfiguring and painful condition with few effective therapies. Led by Professor Fiona Wood and the University of Western Australia, the SATELLITE trial aims to assess safety and preliminary efficacy, building on prior promising results that showed collagen reduction and improved scar vascularisation.
The company is also progressing a Phase 2 study for SNT-4728 in isolated REM sleep behaviour disorder, a condition linked to Parkinson’s disease risk. This trial, funded by Parkinson’s UK, is halfway through recruitment and expected to report results in early 2026.
Financial Position and Outlook
Despite ongoing investment in research and development, Syntara ended the quarter with a solid cash balance of $15.1 million. The company continues to manage cash prudently while advancing multiple clinical programs. Some uncertainty remains regarding outstanding payments from the sale of its mannitol respiratory business, but progress has been made in reconciling amounts owed.
CEO Gary Phillips highlighted the upcoming FDA Type C meeting as a pivotal event that could validate the clinical development plan for amsulostat and attract strategic partnerships. With multiple clinical readouts and regulatory interactions on the horizon, Syntara is positioning itself for accelerated growth and increased investor interest.
Bottom Line?
Syntara’s clinical momentum and regulatory progress set the stage for critical upcoming milestones that could reshape its valuation and partnerships.
Questions in the middle?
- How will the FDA’s feedback from the Type C meeting influence amsulostat’s pivotal trial design?
- What are the timelines and potential impacts of the MDS trials on Syntara’s pipeline value?
- How might the keloid scar and neurodegenerative disorder programs contribute to long-term growth?