- 01Syntara expands Phase 1b SNT-9465; +10 pts; blinded.
- 02Adds Sydney site; faster recruitment.
- 03Top-line Q1 2027 for IND.
- 04Pan-LOX inhibitor; builds on SNT-6302.
Syntara (ASX: SNT) has expanded a Phase 1b study of its next-generation topical anti-fibrotic drug candidate SNT-9465 developed to improve the structure and appearance of hypertrophic sternotomy scars.
The company announced it will add another 10 participants to the initial 20-patient study cohort following encouraging feedback from clinical sites and participant engagement.
A blinded design will also be introduced to support a larger and more robust dataset and add The Skin Hospital in Sydney as a new clinical site to support timely recruitment of new participants.
The expansion is designed to provide a larger safety, tolerability, and exploratory activity dataset for Syntara, with the protocol refined to optimise product application and consistency in treatment across participants.
Syntara chief executive officer Gary Phillips said the decision to expand recruitment would ensure the company captured maximum learnings while delivering more robust results.
Top-line results from the Phase 1b study are expected in the first quarter of 2027 and are intended to support a regulatory investigational new drug application, paving the way for a global development program targeting the first approved pharmacological treatment for skin scarring.
Safety and Tolerability
The Phase 1b study is designed to assess the safety and tolerability of topical SNT-9465 on sternotomy patients with recent hypertrophic scars—defined as thick, raised and abnormal scars caused by an overproduction of collagen when the body’s normal wound-healing process is disrupted by prolonged inflammation.
Each participant will receive SNT-9465 and placebo treatments on distinct regions of the same scar, separated by buffer, for a three-month period, after which scar regions will be evaluated using state-of-the-art imaging and assessment tools.
The baseline LOX (lipoxygenase) activity observed in biopsies from five participants with scars less than 24-months old was markedly higher than that observed in Syntara’s earlier SOLARIA2 study, when the average scar age was 13 years.
Although there are differences in aetiology and location of the scars between the studies (burns vs surgical), it is anticipated that higher LOX levels may drive faster tissue turnover within the scar, creating a greater opportunity for a pan-LOX inhibitor such as SNT-9465 to remodel scar architecture.
“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 for patients,” Mr Phillips said.
Keloid Scar Study
SNT-9465 was designed as a second-generation topical pan-LOX inhibitor to improve tolerability while retaining the intended pan-LOX pharmacology of Syntara’s first-generation compound SNT-6302.
SNT-6302 was the subject of a recent investigator-initiated keloid scar study between the University of Western Australia and the Fiona Wood Foundation.
Six participants in that study have completed the 12-week treatment period and remain in follow-up, with assessments planned to continue for nine months after treatment has concluded.
Several of them experienced mild reversible local reactions (such as redness and itchy skin) after one month or more of treatment, while eight discontinued treatment due to these reactions.
Syntara and Professor Wood will subsequently review the completed dataset and consider how the findings may inform the design of a potential follow-on study in keloid scars, which have a significantly different biology from hypertrophic scars.
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