Key Highlights

  • Syntara has paused recruitment in the Phase 1b study of topical SNT-9465 in patients with hypertrophic sternotomy scars.
  • The pause followed reports of mild to moderate skin irritation in some patients.
  • Unblinded data from completed and ongoing patients will be reviewed before a decision to recommence or discontinue the study.
  • The company expects to complete the review in the current quarter.

Syntara Limited (ASX:SNT), a clinical-stage Drug Development company, has paused recruitment in the Phase 1b study of its topical pan-lysyl oxidase inhibitor, SNT-9465, in participants with hypertrophic sternotomy scars. The media release, dated 10 November 2026, says the pause followed an internal review of local tolerability findings from the blinded study population. The decision affects a study that the company had recently expanded to meet recruitment timelines.

Reason for the Recruitment Pause

After reports of mild to moderate skin irritation in some patients, the company decided to pause recruitment. The pause allows a review of unblinded data from patients who have completed the study and those still enrolled. Only after that review will Syntara decide whether to resume recruitment or discontinue the study.

Skin irritation is a tolerability finding rather than a measure of efficacy, but it is significant for a topical treatment that participants apply to scar tissue over a period of time. The company has not reported the number of patients affected or the severity of the reactions in detail.

Expansion Before the Pause

The company's chief executive said that feedback from patients and trial sites supported the decision to expand recruitment and open an additional clinical site to meet timelines. The tolerability issues that emerged from the blinded population now require the company to pause and analyse the data before going further. The sequence means the study was expanded just before the concern arose.

Company Background and Pipeline

Syntara describes itself as targeting extracellular matrix dysfunction with expertise in amine oxidase chemistry. Its lead candidate, amsulostat, is being developed for the bone marrow cancer myelofibrosis, has Fast Track and Orphan Drug designations from the US FDA, and has completed a Phase 2a trial. SNT-4728 is being studied with Parkinson's UK for sleep disorders and neurodegenerative conditions. The skin scarring study is one part of a broader pipeline built around pan-LOX inhibition.

The pause affects one program within that pipeline. The company's other programs are not discussed in the release, and their progress would depend on separate data and regulatory milestones.

Risks and Matters to Monitor

The review may lead to changes in the study design, the dosing, or the study's continuation, or to its discontinuation. Tolerability concerns can affect the viability of a topical product and the regulatory path for it. Clinical development is inherently uncertain, and early-stage studies frequently change direction after data review. The company says it will analyse all collected data to inform its assessment of the therapeutic approach.

Final Word

Syntara's decision to pause recruitment reflects tolerability concerns in the SNT-9465 Phase 1b study, and the outcome of the unblinded data review will decide whether the study continues. The company expects to complete that review this quarter. The result will indicate whether the skin scarring program can move forward or whether the company will redirect its resources to other parts of its pipeline.