Syntara (ASX:SNT) has taken a significant step forward in the development of its next-generation topical anti-fibrotic therapy, announcing that its lead pan-lysyl oxidase inhibitor, SNT-9465, has completed a Phase 1a clinical trial and will now progress into a Phase 1b study in patients with hypertrophic scars.
The Phase 1a study, involving 32 healthy volunteers, evaluated four ascending doses of SNT-9465 and confirmed “dose-dependent target inhibition and an acceptable tolerability safety profile,” according to the company. The results provide the foundation for an expanded clinical investigation in people living with problematic scarring.
The upcoming Phase 1b trial, to commence ahead of schedule, will use a randomised, double-blind, placebo-controlled split-scar design in 20 adults with hypertrophic sternotomy scars aged 3 and 12 months. Each participant will apply both active cream and placebo to distinct regions of their scar, with a 5-centimetre buffer between treatment areas, for three months. Scars will then be assessed using evaluation tools to measure collagen changes, vascularisation and other biological markers of fibrosis.
The trial builds on insights from Syntara’s SOLARIA2 study, which demonstrated that an earlier-generation compound, SNT-6302, reduced scar tissue collagen, increased vascularisation and promoted beneficial structural changes. These findings helped shape the design and dose-selection strategy for the new programme.
Wound-healing expert Professor Ardeshir Bayat said the progress reflects a turning point in the treatment of one of medicine’s most significant unmet needs. “Skin scarring represents one of the largest untreated burdens in medicine, despite its profound physical, functional and psychosocial impact,” he said. “For the first time, we now have the clinical tools and molecular insight to meaningfully intervene. The biological rationale for topical pan-lysyl oxidase inhibition has always been compelling, and the robust target engagement demonstrated in the Phase 1a study reinforces SNT-9465 as a uniquely promising therapeutic candidate.”
Data from the Phase 1b trial, expected in 2026, will support an FDA Investigational New Drug (IND) application, with Syntara positioning SNT-9465 as a potential first-in-class pharmacological treatment for hypertrophic scarring, an area currently dominated by costly laser therapies and painful steroid injections.
Syntara CEO Gary Phillips said the Phase 1b design incorporates key learnings from SOLARIA2 to evaluate the “commercial attractiveness” of SNT-9465 in what he described as “a multi-billion-dollar market.” He added, “Current standard of care, which includes costly laser therapy or painful steroid injections, requires multiple treatments to produce small incremental improvements. A daily topical treatment with SNT-9465 has the potential to provide profound patient benefits that can be effective without the need for repeat clinical visits.”
The company also reported progress on its parallel scarring program, SATELLITE, led by burns specialist Professor Fiona Wood. The exploratory study examining SNT-6302 in keloid scarring has reached 50 per cent recruitment and remains on track to report results in 2026. Keloid scars differ biologically from hypertrophic scars and represent another area of significant clinical unmet need.