Research & Development
Soligenix's Phase 2a SGX945 clinical trial IND application receives US FDA approval
1 December 2023 -

Soligenix, Inc. (Nasdaq: SNGX), a US-based, late-stage biopharmaceutical company, announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for a Phase 2a clinical trial named, 'Pilot Study of SGX945 (Dusquetide) in the Treatment of Aphthous Ulcers in Behçet's Disease.'

The study is aimed at assessing the safety and efficacy of SGX945 (dusquetide) and is expected to commence patient enrolment in the second half of 2024.

Under this IND, the pilot clinical trial of SGX945 will be an open-label study that will enrol approximately 25 patients age 18 years or older with mild to moderate Behçet's disease active oral and/or genital ulcers. Patients will receive SGX945 as a twice weekly 4-minute intravenous (IV) infusion for 4 weeks. Efficacy endpoints will include the extent of lesion clearance, timeline to lesion clearance, and patient reported quality of life indices.