Policy & Regulation
Soligenix's SGX302 IND clinical trial application receives US FDA approval
29 June 2022 -

Soligenix, Inc. (Nasdaq: SNGX), a US-based late-stage biopharmaceutical company, announced on Tuesday that it has received approval from the United States Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for a Phase 2a clinical trial titled, 'Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis.'

The study is aimed at assessing the safety and efficacy of topically-applied SGX302 (synthetic hypericin) and is likely to commence patient enrolment in the fourth quarter of 2022.

According to this IND, the SGX302 Phase 2a clinical trial will be a randomised, double-blind, placebo-controlled study that will enrol up to 32 patients age 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of their body. Patients are to receive placebo or SGX302 (randomised 1:1) as a twice weekly treatment for up to 18 weeks. Each treatment will consist of the application of SGX302 followed approximately 24 hours later with visible light activation. Efficacy endpoints will include the extent of lesion clearance and patient reported quality of life indices.