Skin scarring program to progress on positive Phase1a result
| Stock | Syntara Ltd (SNT.ASX) |
|---|---|
| Release Time | 26 Nov 2025, 9:06 a.m. |
| Price Sensitive | Yes |
Skin scarring program to progress on positive Phase 1a result
- Next generation topical anti-fibrotic, SNT-9465, to progress to Phase 1b study in hypertrophic scars
- Phase 1a study confirmed dose-dependent target engagement with good safety profile
- Innovative Phase 1b trial design for hypertrophic scars to commence ahead of schedule
Syntara Limited, a clinical-stage drug development company, has announced that its next-generation topical pan-lysyl oxidase (pan-LOX) inhibitor SNT-9465 has successfully completed a first-in-human Phase 1a study and is poised to progress in an innovative Phase 1b study in participants with hypertrophic scars. The Phase 1a dose escalation study in 32 healthy volunteers evaluated creams containing a placebo and 4 different doses of SNT-9465 to determine the optimal dose for complete lysyl oxidase inhibition. The results confirm dose-dependent target inhibition and an acceptable tolerability safety profile, paving the way for progression to the Phase 1b study. The Phase 1b study is a randomised, double-blinded, placebo-controlled split-scar trial in 20 adult participants with hypertrophic sternotomy scars. The study will enrol patients with scars that are 3-12 months in age, a minimum of 15 cm in length and a width of 1-2 cm. Each participant will treat themself for three months with both the blinded active treatment and placebo to distinct portions of their scar with a 5 cm buffer in between. At the end of the treatment period, the scar regions will be assessed by a number of state-of-the-art evaluation tools. This initiative builds on the success and findings of the SOLARIA2 trial which used an earlier generation compound, SNT-6302, to demonstrate the therapeutic potential of topical pan-LOX inhibition by reducing scar tissue collagen content, increasing vascularisation and promoting beneficial structural changes within scar tissue.
Results from the Phase 1b study of SNT-9465 in hypertrophic scars are expected in 2026 and will support an FDA Investigational New Drug (IND) application, paving the way for a global development program targeting the first approved pharmacological treatment for skin scarring.