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Soligenix Receives Japanese Patent for Improved Production of Synthetic Hypericin Composition
Active Ingredient in HyBryte™ for the Treatment of Cutaneous T-Cell Lymphoma PRINCETON, N.J., May 20, 2021 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX)
About this update from Soligenix, Inc.
[{"type":"text","content":"Active Ingredient in HyBryte™ for the Treatment of Cutaneous T-Cell Lymphoma\n\n\nPRINCETON, N.J., May 20, 2021 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Japan Patent Office has allowed the patent application titled \"Systems and Methods for Producing Synthetic Hypericin\". The allowed claims are directed to unique, proprietary methods to produce a novel, highly purified form of synthetic hypericin, and are similar to those previously allowed in the United States (U.S.). Synthetic hypericin is the active pharmaceutical ingredient in HyBryte™ (SGX301), the Company's photodynamic therapy, for which positive primary endpoint results in a pivotal Phase 3 study for the treatment of cutaneous T-cell lymphoma (CTCL) were recently announced. This new patent is the first allowed in Japan covering the proprietary methods developed by the Company and further expands the comprehensive HyBryte™ patent estate, which includes protection on the composition of the purified synthetic hypericin, methods of synthesis and therapeutic methods of use in both CTCL and psoriasis, and is being pursued worldwide. \n\n \n \n \n \n \n \n\n \nHyBryte™ (synthetic hypericin) is a novel first-in-class photodynamic therapy for first-line treatment of early stage CTCL. In the recently completed pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, HyBryte™ achieved a statistically significant treatment response rate (p=0.04) in the primary endpoint after just 6 weeks (Cycle 1) of therapy when compared to placebo. This positive treatment response continued to significantly improve with extended HyBryte™ treatment in the open-label treatment cycles after 12 weeks (Cycle 2) and 18 weeks (Cycle 3) total treatment, reinforcing the positive HyBryte™ primary endpoint treatment response demonstrated in Cycle 1. In addition, HyBryte™ has demonstrated a statistically significant response in both patch and plaque lesions through 12 weeks of treatment (Cycle 2), highlighting the unique benefit of using visible light with its deeper skin penetration. HyBryte™ was well tolerated throughout the study and no mutagenic risks have been identified, unl...