Soligenix Gets FDA Nod For Mid-Stage Psoriasis Study

The U.S. Food and Drug Administration (FDA) has cleared Soligenix’s SNGX Investigational New Drug (IND) application for Phase 2a clinical trial Evaluating SGX302 in the treatment of patients with Mild-to-Moderate Psoriasis.

This study is designed to evaluate the safety and efficacy of topically-applied SGX302 (synthetic hypericin), will enrol up to 32 patients age 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of their body.

Christopher J. Schaber, PhD, President and Chief Executive Officer, said, “Psoriasis is an ongoing unmet medical need, with as many as 7.5 million people in the U.S. and 60-125 million people worldwide affected by this incurable disease. Given our promising results with hypericin to date, including a small Phase 1/2 proof of concept clinical trial in mild-to-moderate psoriasis, we are hopeful synthetic hypericin will have a role to play in helping patients suffering from this difficult to treat and chronic disease."

The company anticipates to begin patient enrolment in Phase 2a clinical trial in the fourth quarter of 2022.

Soligenix Shares are trading high 3 percent at $0.57