Syntara has paused recruitment in its Phase 1b study of SNT-9465 after some participants reported mild to moderate skin irritation from the topical scar treatment.
The Sydney drug developer said the decision followed an internal review of local tolerability findings from the blinded study population. The trial is testing SNT-9465, a topical inhibitor of the lysyl oxidase family of enzymes, in people with hypertrophic scars from sternotomy, the incision made through the breastbone during open heart surgery.
Recruitment will stay on hold while the company reviews unblinded data from patients who have completed the study and those still taking part. Syntara said it will then decide whether to restart recruitment or discontinue the study.
The pause is a change of course for a trial that had recently been growing. Chief executive Gary Phillips said early responses had encouraged the company to widen the study.
“The feedback received from patients and trial sites during the study supported our decision to expand recruitment and open an additional clinical site to meet recruitment timelines. However, the emergence of tolerability issues in this blinded study population requires us to now pause recruitment and analyse the available data before progressing further.
“We will analyse all collected data to maximise the insights gained to inform our assessment of the potential of this therapeutic approach. We sincerely thank the participants, investigators and study teams for their patience while we complete our review, which we expect to complete in this current quarter.”
The scar program is one of several Syntara projects built on its work in amine oxidase chemistry. The company is also working with Professor Fiona Wood and the University of Western Australia on keloid scars.
Its lead candidate, amsulostat, is being developed for the bone marrow cancer myelofibrosis. It has completed a Phase 2a trial, given alone and with a JAK inhibitor, and has Fast Track and Orphan Drug designations from the US Food and Drug Administration. Two Phase 1c/2 studies of amsulostat have started in myelodysplastic syndrome, another blood cancer. Syntara is also studying SNT-4728 with Parkinson's UK as a possible treatment for sleep disorders and for slowing neurodegenerative diseases such as Parkinson's.