Phase 2 Clinical Trial of Synthetic Hypericin Underway for Treatment of Mild-to-Moderate Psoriasis

Soligenix, Inc announced that patient enrollment is now open for its Phase 2a study evaluating SGX302 (synthetic hypericin) in the treatment of mild-to-moderate psoriasis.¹ 

The Phase 2a clinical trial for synthetic hypericin will enroll up to 42 patients ages 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of their body. In Parts A and B, all patients will apply the study drug twice per week and will activate the drug with visible light 24 ± 6 hours later using the supplied visible light devices and according to the manufacturer's instructions. Patients will undergo treatments for a total of 18 weeks, then refrain from using any other psoriasis treatments for 4 weeks. In Part A, 5 to 10 enrolled patients will be assigned open-label SGX302 (0.25% hypericin). In Part B, patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment.

During the trial, the treated lesions will be assessed immediately before and after light treatments for overall disease status through week 4 of follow-up. Efficacy endpoints will include lesion clearance and patient reported quality of life indices.

SGX302 is a photodynamic light therapy which uses synthetically developed hypericin applied as an ointment and applied with visible fluorescent light. It is designed to be a safe alternative for treatment of mild-to-moderate psoriasis, giving patients more treatments to manage the disease while accumulating less toxicities.

As many as 7.5 million people in the United States and 60 to 125 million people worldwide affected by psoriasis. Approximately 80% of patients have mild-to-moderate forms of the incurable disease. Mild psoriasis is generally characterized by the involvement of less than 3% of the body surface area (BSA), while moderate psoriasis will typically involve 3 to 10% BSA and severe psoriasis greater than 10% BSA. Between 20% and 30% of individuals with psoriasis will develop chronic, inflammatory arthritis (psoriatic arthritis) that can lead to joint deformations and disability.

Reference

1.Soligenix Initiates Phase 2 Clinical Trial of SGX302 (synthetic hypericin) for the Treatment of Mild-to-Moderate Psoriasis. PR Newswire. Published December 19, 2022. Accessed December 19, 2022.