Soligenix Initiates Phase 2 Trial of SGX302 for Mild to Moderate Psoriasis

Patient enrollment has been opened for Soligenix, Inc.'s Phase 2a study evaluating SGX302 (synthetic hypericin) for the treatment of mild to moderate psoriasis.

"We are excited to expand synthetic hypericin's development into different cutaneous T-cell diseases such as psoriasis, as a component of our long-term strategy to enhance the value of this unique compound," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Given our promising published results with hypericin to date, including a small Phase1/2 proof of concept clinical trial in mild to moderate psoriasis, and the Phase 3 FLASH study in cutaneous T-cell lymphoma, where we filed a New Drug Application (NDA) this month, we are hopeful synthetic hypericin will have a role to play in helping patients suffering from this difficult to treat and chronic disease." 

The Phase 2a clinical trial (protocol number HPN-PSR-01) will target enrollment of up to 42 patients ages 18 years or older with mild to moderate, stable psoriasis covering 2-30% of their body. In both 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 and, on completion, will be followed for a 4-week follow-up period in which patients will not receive other psoriasis treatments. In Part A, 5-10 patients will be assigned open-label SGX302 (0.25% hypericin) at the time of enrollment. Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment.

Active dermatologic assessment of treated lesions for adverse events will be performed immediately before and during light treatments. Patients will be assessed for overall disease status through 4 weeks of follow-up. Efficacy endpoints will include the extent of lesion clearance and patient reported quality of life indices. Routine safety laboratories also will be collected.