Soligenix Announces Top-line Results of the Phase 2a Study of SGX302 (Synthetic Hypericin) in Patients with Mild-to-Moderate Psoriasis

Core Insights - Soligenix, Inc. announced positive results from the third cohort of its Phase 2a trial for SGX302, a treatment for mild-to-moderate psoriasis, utilizing an optimized gel formulation of synthetic hypericin [1][2][3] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, including treatments for psoriasis and cutaneous T-cell lymphoma (CTCL) [1][12] Clinical Trial Results - The third cohort of the Phase 2a trial involved four patients treated with an improved gel formulation for 18 weeks, showing no drug-related adverse events and significant improvements in various psoriasis assessment indices [2][5] - One patient achieved an "Almost Clear" status in the Investigator Global Assessment (IGA), with a PASI score improvement exceeding 50%, indicating treatment success [2][3] - The gel formulation was designed for easier application compared to the previous ointment, leading to similar or improved outcomes [2][5] Market Potential - Psoriasis affects approximately 60-125 million people globally, with a treatment market valued at around $15 billion in 2020, projected to reach $40 billion by 2027 [3][10] - The success of HyBryte™ in CTCL trials suggests potential for SGX302 in treating psoriasis, which is also linked to dysregulated T-cells [3][12] Treatment Mechanism - Synthetic hypericin is a first-in-class photodynamic therapy that activates T-cell apoptosis using visible light, avoiding long-term risks associated with traditional UV light therapies [4][7] - This approach aims to treat deeper skin lesions effectively while minimizing risks of secondary malignancies and serious infections associated with systemic treatments [7][9] Psoriasis Overview - Psoriasis is a chronic inflammatory skin condition affecting quality of life and is associated with various comorbidities, including cardiovascular and psychological conditions [8][10] - The most common type, plaque psoriasis, affects about 80% of patients, with varying severity levels impacting treatment approaches [8][9]