Syntara Limited has achieved a significant milestone in dermatological drug development by dosing the first participant in a Phase 1a/b clinical trial of SNT-9465, a topical pan-lysyl oxidase inhibitor developed for treating hypertrophic scars. The trial commenced at the Linear (Joondalup Clinical Trial Centre) in Perth, marking the beginning of what could lead to the first approved pharmacological treatment for skin scarring.
Trial Design and Objectives
The Phase 1a study will initially focus on determining the optimal dose for complete lysyl oxidase inhibition while assessing safety and tolerability in healthy participants. Following successful completion of the initial phase, an open-label Phase 1b extension will evaluate improvements in the appearance and composition of hypertrophic scars after three months of daily treatment.
The trial design addresses a critical gap in current treatment options, as existing standard care relies on costly laser therapy or painful steroid injections that require multiple treatments for only small incremental improvements. SNT-9465 represents a potential paradigm shift by offering a daily topical treatment that could provide profound patient benefits through a non-invasive approach without requiring repeat clinical visits.
Clinical Significance and Market Need
The development of SNT-9465 addresses a substantial medical need, with approximately 100 million patients developing scars in the developed world each year as a result of elective operations and operations after trauma. Syntara CEO Gary Phillips emphasized the significance of this unmet need, stating that discussions with clinicians and global key opinion leaders in scar treatment have highlighted the limitations of current therapeutic options.
Regulatory Pathway and Timeline
Trial results are expected in the first half of 2026 and are anticipated to support an FDA Investigational New Drug (IND) application. This regulatory milestone would pave the way for a global development program, potentially establishing SNT-9465 as the first approved pharmacological treatment specifically designed for skin scarring.
The topical formulation of SNT-9465 as a next-generation anti-fibrotic drug represents a novel approach to scar treatment, targeting the underlying fibrotic processes that contribute to hypertrophic scar formation. By inhibiting lysyl oxidase, the drug aims to modulate collagen cross-linking and reduce the excessive fibrotic response characteristic of problematic scarring.
