Syntara pauses SNT-9465 Phase 1b recruitment after skin irritation reports
Syntara Limited (ASX: SNT) has paused recruitment of the Phase 1b study of its topical pan-lysyl oxidase inhibitor, SNT-9465, in participants with hypertrophic sternotomy scars. The pause follows an internal review of local tolerability findings from the blinded study population.
The company received reports of mild to moderate skin irritation in some patients. Recruitment has been paused to allow a thorough review of unblinded data from completed and ongoing patients.
Once that review is finished, Syntara will decide whether to recommence recruitment or discontinue the study.
Management response
Syntara CEO Gary Phillips said patient and trial site feedback during the study had supported the decision to expand recruitment and open an additional clinical site to meet recruitment timelines. The emergence of tolerability issues, however, required a pause.
The earlier Phase 1b cohort expansion lifted enrolment from 20 to 30 participants and moved the expected top-line readout to Q1 2027.
Gary Phillips, CEO, Syntara
“We will analyse all collected data to maximise the insights gained to inform our assessment of the potential of this therapeutic approach…”
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What happens next for Syntara
Syntara has outlined two steps following the pause:
- A review of unblinded data from completed and ongoing patients, which the company expects to complete in the current quarter.
- A decision, following that review, on recommencing recruitment or discontinuing the study.
Syntara is also evaluating topical pan-LOX inhibition in skin scarring through this study, while its lead candidate amsulostat continues to be developed in myelofibrosis.
FDA feedback on the Phase 2b design supports a trial of roughly 100 myelofibrosis patients over nine months, targeting those with an inadequate response to JAK inhibitors.
Want To Follow Syntara’s SNT-9465 Review And Amsulostat Progress?
Syntara has paused recruitment in its SNT-9465 Phase 1b scar study while it reviews unblinded tolerability data, with a decision on the study’s future to follow. Meanwhile, its lead candidate amsulostat continues to advance in myelofibrosis, backed by FDA feedback on a roughly 100-patient Phase 2b design.
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