Syntara has announced it will enlarge its clinical trial of a topical scar treatment.
It is adding 10 participants and a new clinic in Sydney. Recruitment for its Phase 1b study of SNT-9465 neared its initial target of 20 participants. SNT-9465 is a second-generation topical pan-LOX inhibitor, and the study is testing it in people with hypertrophic scars after sternotomy, the cut through the breastbone used in open-heart surgery. The study will now enrol 30.
Syntara said the decision followed encouraging feedback from clinical sites and strong participant engagement. It stressed that the expansion was not based on efficacy data, as the double-blind, placebo-controlled trial remains blinded. The Skin Hospital in Sydney has joined as an extra site to help recruit the larger group. Top-line results are now expected in the first quarter of 2027.
Each participant receives SNT-9465 on one area of their scar and placebo on a comparable area. This lets researchers compare responses within the same person rather than across people with different scars. The study is designed mainly to assess safety and tolerability, with exploratory measures of biological and clinical activity. The company said it refined the protocol during the study to improve product application and keep treatment consistent across participants.
Chief executive Gary Phillips said the expansion would strengthen the results. "We are pleased with the strong engagement from participants and clinical sites in the SNT-9465 Phase 1b study. This has supported our decision to expand recruitment from 20 to 30 participants to ensure we capture the maximum learnings, while maintaining the study's blinded design.
"Expanding the study at this stage is very cost-effective and will deliver more robust results in Q1 2027. Hypertrophic scarring remains an area of significant unmet need, and we look forward to evaluating whether the biological rationale for pan-LOX inhibition translates into an acceptable safety and tolerability profile and evidence of clinical activity in this study."
SNT-9465 was designed to be better tolerated than Syntara's first-generation compound, SNT-6302, while working the same way. New data from a separate keloid scar study show why a successor is needed.
The investigators started the study, known as SATELLITE, and are running it with the University of Western Australia and the Fiona Wood Foundation. Six participants have completed 12 weeks of treatment with SNT-6302 and will be followed for nine months. Eight participants stopped treatment because of mild, reversible skin reactions that appeared after a month or more of use. The reactions were mainly redness and itching.
Syntara said this pattern matched what it saw in its earlier SOLARIA2 study of the same compound. It said the result further supported its decision to move to SNT-9465.
The company acknowledged the findings were limited. The study is exploratory, few participants completed treatment, and their scars varied widely in size, location on the body and age.
Further end-of-treatment and follow-up data are expected to be presented or published. Syntara and Professor Wood will then review the full dataset and consider whether it could shape a follow-on study in keloid scars.
Syntara's lead drug candidate is still amsulostat, which has completed a Phase 2a trial in the bone marrow cancer myelofibrosis.
