- Next generation topical anti-fibrotic, SNT-9465, to progress to Phase 1b study in hypertrophic scars following successful completion of Phase 1a
- Phase 1a Single Ascending Dose clinical trial confirmed dose-dependent target engagement with good safety profile
- Randomised, double-blinded, placebo-controlled innovative Phase 1b trial design for hypertrophic scars using state of the art evaluation tools to commence ahead of schedule
- Fiona Wood Foundation / University of Western Australia exploratory clinical trial in keloid scarring using first generation Syntara topical drug reaches 50% recruitment
- Syntara’s portfolio and clinical trial program on track to deliver multiple outcomes in 2026.
Syntara Limited (ASX:SNT), a clinical-stage drug development company, is pleased to announce 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 announced today confirm dose-dependent target inhibition and an acceptable tolerability safety profile, paving the way for progression to an integrated Phase 1b study in hypertrophic scars.
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.
Globally renowned skin scarring scientist and surgeon Professor Ardeshir Bayat, said: “Skin scarring represents one of the largest untreated burdens in medicine, despite its profound physical, functional and psychosocial impact. 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. I’m encouraged by the progress to date and look forward to the next stage of clinical development.”
Results 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.
Syntara CEO Gary Phillips said: “The learnings from the earlier SOLARIA2 study have been incorporated into this Phase 1b study to enable us to truly evaluate the commercial attractiveness of topical pan-LOX inhibition in a multi-billion dollar market. 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.”
Alongside the study of SNT-9465 and hypertrophic scars, the parallel scarring program under the leadership of Professor Fiona Wood is focused on keloid scars, which differ biologically from hypertrophic scars and present unique challenges for patients. Recruitment for the Syntara-supported pilot study, SATELLITE, has progressed well, with 50% of the subjects having commenced treatment, and the study remains on track to deliver results in 2026.
