Syntara’s Scar Drug Faces Critical Phase 1b Test Amid High Market Expectations
Syntara Limited has successfully completed Phase 1a trials for its topical anti-fibrotic drug SNT-9465, demonstrating dose-dependent target engagement and safety, and is now progressing to an innovative Phase 1b study in hypertrophic scars.
- Phase 1a trial confirms dose-dependent target inhibition and good safety profile
- Phase 1b randomized, double-blinded, placebo-controlled trial to start ahead of schedule
- Parallel keloid scar study with first-generation drug reaches 50% recruitment
- Results expected in 2026 to support FDA Investigational New Drug application
- Potential to disrupt multi-billion dollar scar treatment market with topical therapy
Syntara's Clinical Milestone
Syntara Limited (ASX – SNT), a clinical-stage biotech company, has announced a significant step forward in its development of topical anti-fibrotic therapies with the successful completion of the Phase 1a clinical trial for SNT-9465. This next-generation pan-lysyl oxidase inhibitor demonstrated clear dose-dependent target engagement alongside a favorable safety profile in healthy volunteers, setting the stage for the upcoming Phase 1b study in patients with hypertrophic scars.
Innovative Phase 1b Trial Design
The Phase 1b trial will be a randomized, double-blinded, placebo-controlled split-scar study involving 20 adult participants with hypertrophic sternotomy scars. Each participant will apply both active treatment and placebo to separate sections of their scar over three months, allowing for direct intra-patient comparison. This design leverages advanced evaluation tools to assess scar improvements, building on insights from the earlier SOLARIA2 trial which showed promising therapeutic effects of topical pan-LOX inhibition on scar tissue structure and vascularisation.
Broader Scar Treatment Program
Alongside SNT-9465’s development, Syntara is progressing a parallel clinical program targeting keloid scars, a more challenging form of scarring. The SATELLITE pilot study, supported by the Fiona Wood Foundation and University of Western Australia, is already halfway through recruitment. Both programs aim to deliver clinical data in 2026 that will underpin an FDA Investigational New Drug application, a crucial step toward global regulatory approval.
Market Potential and Unmet Need
Current scar treatments often involve costly and invasive procedures such as laser therapy or steroid injections, which require multiple sessions and offer limited improvements. Syntara’s topical approach with SNT-9465 promises a more convenient, non-invasive daily treatment that could significantly improve patient outcomes and reduce healthcare burdens. CEO Gary Phillips highlighted the potential to address a multi-billion dollar market with a therapy that could transform the standard of care for hypertrophic scars.
Expert Endorsement and Next Steps
Renowned skin scarring expert Professor Ardeshir Bayat emphasized the importance of this development, noting the profound physical and psychosocial impact of scarring and the compelling biological rationale for pan-lysyl oxidase inhibition. The upcoming Phase 1b results, expected next year, will be pivotal in confirming the drug’s efficacy and commercial viability. Syntara also plans a webinar featuring Professor Bayat and company executives to discuss the clinical program and market outlook.
Bottom Line?
Syntara’s advancement of SNT-9465 marks a promising stride toward a novel, patient-friendly scar treatment with significant market potential.
Questions in the middle?
- Will Phase 1b results confirm meaningful clinical improvements in hypertrophic scars?
- How will regulatory agencies respond to the novel topical pan-LOX inhibitor approach?
- What are the commercial partnership or licensing plans following Phase 1b outcomes?
