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Topadur's Phase 2a Trial of TOP-N53 Advances for Systemic Sclerosis
Topadur Pharma AG has announced an important progression in its Phase 2a trial for TOP-N53, aimed at treating systemic sclerosis-associated digital ulcers. The Swiss biopharmaceutical firm has received a recommendation from the Safety Review Committee to advance to higher dose levels. This follows a safety review and the completion of the first patient cohort with no serious adverse reactions.
TOP-N53 is a topical therapeutic candidate that improves microcirculation and aids tissue repair by combining nitric oxide release and phosphodiesterase-5 inhibition. Already evaluated in a Phase 1 study, its current Phase 2a trial is conducted in Switzerland and France, focusing on its safety and tolerability.
The trial addresses the unmet medical need for local treatments of digital ulcers, often painful and recurrent in systemic sclerosis patients. Recruitment for the second cohort is set to begin in November, with six clinical centers participating. The trial is part of a start-up project supported by Innosuisse.
R. H.
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