Soligenix, Inc.’s SGX302 (Synthetic Hypericin) Demonstrates “Clear Biological Signal” in Phase 2a PsO Study


Visible light-activated synthetic hypericin is a novel, first-in-class PDT.

Soligenix, Inc.’s SGX302 (synthetic hypericin) showed a clear biological signal in an initial five people with mild-to-moderate psoriasis, the company reports.

Now, the study is expected to enroll at least an additional five subjects, exploring the use of SGX302 in the standard of care psoriasis setting, prior to undertaking the larger phase of the study.  

Visible light-activated synthetic hypericin is a novel, first-in-class, photodynamic therapy (PDT). Synthetic hypericin is a potent photosensitizer that is topically applied to skin lesions and absorbed by cutaneous T-cells. With subsequent activation by safe, visible light, T-cell apoptosis is induced, addressing the root cause of psoriasis lesions. 

Evaluation of the initial five subjects enrolled demonstrated a clear biological signal, with the majority of patients recording an improvement in the PASI Psoriasis Area and Severity Index (PASI) score. Enrolling additional patients will enable Soligenix to evaluate the use of SGX302 in the context of accelerated light treatment and additional adjunct treatment.

"Patients with mild-to-moderate disease do not qualify for the use of biologics and have fewer treatment options. The patients enrolled in this study all demonstrated clinical improvement and, with the experience gained in this first portion of the study, we anticipate being able to further improve responses as we move forward," says Practical Dermatology® magazine’s Chief Medical Editor Neal Bhatia, MD, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego and Chair of the Company's Psoriasis MAB, in a news release. "Having previously participated in the positive Phase 3 clinical trial of HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL), I have had a clinical interest in this novel therapy and am pleased that the Soligenix team is advancing synthetic hypericin in psoriasis where there remains an unmet medical need,” he said.

“ Similar to CTCL, psoriasis is a chronic disease where the management of side effects and toxicities is as important as the management of the disease itself,” Dr. Bhatia continues. “Psoriasis affects more than 7.5 million patients in the U.S. alone, and 60-125 million people worldwide. Having treated psoriasis patients for over 20 years and seen first-hand how they struggle to find good treatment options, access to an additional effective and safe therapy would add significantly to patient care and quality of life for many people that are living with this disease. I look forward to working with my esteemed colleagues to support Soligenix in advancing this important development program forward."

"We are pleased with the initial results from our Phase 2a trial," adds Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The expansion of this psoriasis study continues our evaluation of synthetic hypericin into other disease indications, including non-orphan indications, where there remains an unmet medical need.”

He adds that the company anticipates being in a position to report additional SGX302 study data before year-end, as well as the outcome of our ongoing discussions with the U.S. Food and Drug Administratioom regarding a feasible and executable trial design for a confirmatory Phase 3 study with HyBryte in the treatment of early stage CTCL.

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