Syntara’s SNT-5505 Secures FDA Fast Track, Boosting Development Prospects
Syntara Limited’s lead drug candidate SNT-5505 has secured FDA Fast Track designation, expediting its development for treating myelofibrosis, a rare and serious blood cancer with limited therapies.
- FDA Fast Track designation granted for SNT-5505
- Targets myelofibrosis patients with inadequate response to JAK inhibitors
- Potential for accelerated approval and priority review
- Phase 2 clinical trial ongoing with interim data due mid-June
- Novel mechanism inhibiting lysyl oxidases to reduce fibrosis
Syntara Gains Regulatory Momentum
Syntara Limited (ASX – SNT), an Australian clinical-stage biotech firm, has achieved a significant regulatory milestone with the US Food and Drug Administration (FDA) granting Fast Track designation to its lead candidate, SNT-5505. This designation is aimed at expediting the development and review process for drugs addressing serious conditions with unmet medical needs; in this case, myelofibrosis, a rare and debilitating bone marrow cancer.
Myelofibrosis affects approximately 15 people per million worldwide and is characterised by the build-up of scar tissue in the bone marrow, leading to impaired blood cell production. Current standard treatments, primarily JAK inhibitors, often come with severe side effects and limited efficacy, leaving a substantial patient population with inadequate therapeutic options.
A Novel Therapeutic Approach
SNT-5505 works through a novel mechanism by inhibiting lysyl oxidases; enzymes involved in fibrosis and growth factor signalling pathways. Early clinical data have shown promising results, with improvements in patient symptom scores and a favourable safety profile. The Fast Track designation reflects the FDA’s recognition of this potential benefit and the growing body of preclinical and clinical evidence supporting SNT-5505.
With this status, Syntara gains more frequent communication with the FDA, eligibility for accelerated approval pathways, priority review, and the possibility of rolling submissions for the New Drug Application. These advantages could significantly shorten the timeline to market if subsequent trials confirm efficacy and safety.
Clinical Progress and Upcoming Data
Syntara is currently advancing SNT-5505 through a Phase 2 clinical trial, investigating its use in combination with JAK inhibitors for patients who have shown suboptimal responses to existing therapies. Interim data from this study are scheduled for presentation at the European Hematology Association meeting in mid-June 2025, which will be closely watched by investors and clinicians alike.
Beyond myelofibrosis, Syntara is developing additional programs targeting fibrotic and inflammatory diseases, leveraging its expertise in amine oxidase chemistry. The company’s pipeline also includes candidates for myelodysplastic syndrome and neurodegenerative conditions, highlighting a broad strategic focus on diseases with significant unmet needs.
Strategic Implications
CEO Gary Phillips emphasised the importance of this regulatory recognition, framing it as a validation of SNT-5505’s therapeutic promise and a catalyst for rapid advancement towards becoming a new standard of care. While the Fast Track designation does not guarantee approval, it positions Syntara favourably in a competitive and challenging therapeutic area.
Bottom Line?
Syntara’s Fast Track status for SNT-5505 sets the stage for accelerated development, but upcoming trial data will be critical to sustaining momentum.
Questions in the middle?
- Will interim Phase 2 data confirm SNT-5505’s efficacy and safety to justify accelerated approval?
- How will Syntara position SNT-5505 commercially against existing JAK inhibitors and emerging therapies?
- What are the timelines and prospects for expanding SNT-5505’s indications beyond myelofibrosis?
