Syntara Limited has initiated dosing in its Phase 1c SATELLITE trial for a novel topical treatment targeting keloid scars, marking a significant step in addressing a $3.5 billion global market. The study, led by Professor Fiona Wood, will evaluate safety and early efficacy over three months.
- First patient dosed in Phase 1c SATELLITE trial for topical SNT-6302
- Trial led by Professor Fiona Wood in partnership with University of Western Australia
- Study focuses on safety, tolerability, and preliminary efficacy in active keloid scars
- Next-generation agent SNT-9465 Phase 1 trial to start by end of July
- Trial includes placebo-controlled design for patients with multiple keloids
Breaking New Ground in Keloid Scar Treatment
Syntara Limited (ASX, SNT) has announced a key milestone in its clinical development program with the dosing of the first patient in the Phase 1c SATELLITE trial. This study investigates the safety and tolerability of SNT-6302, a topical lysyl oxidase inhibitor designed to treat keloid scars, a challenging and often debilitating condition with limited effective therapies.
The SATELLITE trial is spearheaded by renowned burns and wound specialist Professor Fiona Wood, in collaboration with the University of Western Australia. It aims to address the significant unmet clinical need in the global keloid and hypertrophic scar market, which exceeds US$3.5 billion annually. Keloid scars are notorious for their progressive growth, causing disfigurement, chronic pain, itching, and psychological distress, underscoring the urgency for innovative treatments.
Trial Design and Scientific Rationale
The open-label study includes up to 20 adult participants with active keloids ranging from 5 to 25 cm². After a four-week placebo run-in, patients will apply SNT-6302 topically four days per week for three months. For those with multiple keloids, a placebo-controlled, double-blind design will allow direct comparison within the same patient, enhancing the robustness of the data.
Key endpoints include safety, tolerability, pharmacokinetics, and preliminary efficacy measures such as changes in scar volume, collagen content, tissue stiffness, and patient-reported symptoms like pain and itch. These assessments build on encouraging findings from the earlier SOLARIA2 study, where SNT-6302 reduced collagen content by 30% and improved scar vascularisation, both critical factors in keloid pathology.
Honouring a Legacy and Looking Ahead
The announcement also pays tribute to the late Dr Mark Fear, a Senior Scientist at the Fiona Wood Foundation and Associate Professor at UWA, whose decade-long contributions to fibrosis research have been foundational to Syntara’s scar treatment programs. His passing represents a poignant moment for the research community and the company alike.
Looking forward, Syntara plans to commence a Phase 1 trial for its next-generation topical pan-lysyl oxidase inhibitor, SNT-9465, targeting hypertrophic scars by the end of July. This progression underscores the company’s commitment to expanding its pipeline and addressing broader scar-related conditions.
With the SATELLITE trial underway, Syntara is poised to generate critical clinical data that could reshape therapeutic options for patients suffering from keloid scars, a condition that has long been underserved.
Bottom Line?
Syntara’s SATELLITE trial launch marks a promising advance in scar treatment, with pivotal data expected to shape future therapeutic landscapes.
Questions in the middle?
- Will SNT-6302 demonstrate meaningful clinical improvements beyond safety in this early trial?
- How might the loss of Dr Mark Fear impact ongoing research momentum and collaboration?
- What are the prospects for commercial partnerships or accelerated regulatory pathways following Phase 1c results?