Soligenix Inc (SNGX)

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SNGX 7/11/2023: Phase 2a Study in Mild-to-Moderate Psoriasis
Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need,announced today the expansion of its Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis after demonstration of biological effect in the initial five subjects. 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.

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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) 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," stated Neal Bhatia, MD, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego and Chair of the Company's Psoriasis MAB. "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. 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. 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," stated 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. Current estimates show as many as 60-125 million people worldwide living with the condition, with a global treatment market valued at approximately $15 billion in 2020 and projected to reach as much as $40 billion by 2027. The success of HyBryte™ in targeting malignant T-cells during CTCL clinical trials is a promising indicator of the ability of SGX302 to provide a much-needed approach for the treatment of mild-to-moderate psoriasis, also caused by dysregulated T-cells. We anticipate being in a position to report additional SGX302 study data before year-end, as well as the outcome of our ongoing discussions with the FDA regarding a feasible and executable trial design for a confirmatory Phase 3 study with HyBryte™ in the treatment of early stage CTCL."