Syntara’s New Scar Drug Trial Begins Amid Unmet Need and Market Pressure
Syntara Limited has initiated dosing in its Phase 1a/b trial for SNT-9465, a topical drug targeting hypertrophic scars, aiming to offer a non-invasive alternative to current treatments. Results expected in early 2026 could pave the way for global development and FDA approval.
- First participant dosed in Phase 1a/b trial of SNT-9465
- Trial to assess safety, tolerability, and efficacy in hypertrophic scars
- SNT-9465 designed as a daily topical treatment to replace invasive therapies
- Results due H1 2026 to support FDA Investigational New Drug application
- Syntara advancing multiple fibrosis and inflammation drug programs
Syntara Advances Scar Treatment Pipeline
Syntara Limited (ASX – SNT) has reached a significant milestone by dosing the first participant in its Phase 1a/b clinical trial for SNT-9465, a next-generation topical anti-fibrotic drug aimed at treating hypertrophic scars. This development marks a crucial step forward in the company’s ambition to address a substantial unmet medical need in scar management.
The trial, conducted at the Linear Joondalup Clinical Trial Centre in Perth, Western Australia, will initially focus on evaluating the safety and tolerability of SNT-9465 in healthy volunteers. The Phase 1a portion is designed to identify the optimal dose that achieves complete inhibition of lysyl oxidase enzymes, which play a key role in scar tissue formation. Following this, the Phase 1b extension will assess the drug’s effectiveness in improving the appearance and structure of hypertrophic scars after three months of daily application.
Addressing a Large and Underserved Market
Hypertrophic scars and keloids affect millions globally, with approximately 100 million patients developing scars annually in developed countries due to surgeries or trauma. Current treatment options, such as laser therapy and steroid injections, are often costly, painful, and require repeated clinical visits with only modest improvements. Syntara’s CEO, Gary Phillips, highlighted the potential of SNT-9465 to transform this landscape by offering a non-invasive, daily topical treatment that could significantly enhance patient comfort and outcomes.
The market opportunity is substantial, with an estimated value of around $3.5 billion. Syntara’s prior SOLARIA2 trial with an earlier compound demonstrated promising results, including reduced collagen content and improved scar vascularisation. Building on this, SNT-9465 has been optimized for stronger anti-scarring effects and better tolerability suitable for everyday use.
Broader Clinical Ambitions and Collaborations
Beyond SNT-9465, Syntara maintains a robust pipeline targeting fibrosis and inflammatory diseases, including blood cancers and neurodegenerative conditions. The company’s ongoing collaboration with the Fiona Wood Foundation and the University of Western Australia continues to explore treatments for keloid scars, further underscoring its commitment to innovative scar therapies.
Results from the current trial are anticipated in the first half of 2026 and will support an FDA Investigational New Drug application, potentially unlocking a global development program. If successful, SNT-9465 could become the first approved pharmacological treatment for skin scarring, a breakthrough in a field that has seen little innovation in recent years.
Bottom Line?
Syntara’s progress with SNT-9465 signals a potential paradigm shift in scar treatment, but upcoming trial results will be critical to validating its promise.
Questions in the middle?
- Will SNT-9465 demonstrate clear clinical benefits over existing scar therapies?
- How quickly can Syntara advance to later-stage trials and potential regulatory approvals?
- What partnerships or commercial strategies will Syntara pursue to maximise SNT-9465’s market impact?
