Soligenix Receives European Patent for Improved Production of Synthetic Hypericin
Tuesday, September 03, 2024
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 that the European Patent Office has granted the patent entitled "Systems and Methods for Producing Synthetic Hypericin". The newly issued patent's claims are directed to a novel, highly purified form of synthetic hypericin manufactured through a unique proprietary process. Synthetic hypericin is the active pharmaceutical ingredient in HyBryte™, the Company's photodynamic therapy for the treatment of cutaneous T-cell lymphoma (CTCL), set to initiate a confirmatory Phase 3 clinical trial before the end of the year. This new European granted patent (EP3423428) is a related patent to US Pat. No. 10,053,413, previously issued in the United States (US). Both patents are expected to expire in 2036, and form part of a larger patent family, including previously granted US patents covering methods of use (US Pat. No. 7,122,518) and methods of synthesis (US Pat. No. 8,629,302), as well as other granted patents throughout the world.
HyBryte™ is a novel, first-in-class, photodynamic therapy that combines synthetic hypericin, a highly potent photosensitizer that is applied to the cancerous CTCL skin lesions and activated using a safe, visible light treatment. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure.
HyBryte™ has shown statistically significant efficacy in a Phase 3 randomized, placebo-controlled trial (FLASH trial, Fluorescent Light Activated Synthetic Hypericin) and will be initiating a second confirmatory Phase 3 placebo-controlled study (FLASH2) in 4Q 2024. Additional supportive studies have demonstrated the utility of longer treatment times (Study RW-HPN-MF-01), the lack of significant systemic exposure to hypericin after topical application (Study HPN-CTCL-02) and its relative efficacy and tolerability compared to Valchlor® (Study HPN-CTCL-04).
"This recently issued patent continues to expand, strengthen and protect our synthetic hypericin patent estate," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With important contributions from key patient advocacy organizations, such as the Cutaneous Lymphoma Foundation, we look forward to completing the confirmatory Phase 3 CTCL study to potentially address the unmet medical need that currently exists in this orphan disease."
Source: prnewswire.com
