Soligenix, a late-stage biopharmaceutical company specializing in treating rare diseases with unmet medical needs, has announced that the US Food and Drug Administration (FDA) has granted them a Type A meeting to talk about their refusal to file (RTF) letter for the new drug application (NDA) for HyBryte™ (synthetic hypericin). This is to discuss the treatment of early stage cutaneous T-cell lymphoma (CTCL), where it has successfully displayed statistically significant results in a Phase 3 clinical trial. Following this meeting, which is being scheduled now, an update on the outcome is expected by the end of April.

Soligenix is determined to work with the FDA staff as quickly as possible to understand the open issues and clarify any potential path forward to resolve this issue. Once they have clarity on the next steps, Soligenix will provide further updates.

HyBryte™ is the first of its kind, a novel photodynamic therapy utilizing safe visible light for activation, with the active ingredient being synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells and then activated by visible light approximately 24 hours later. It has the advantage of penetrating more deeply into the skin and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure.

HyBryte™ has already received orphan drug and fast track designations from the FDA, as well as an orphan designation from the European Medicines Agency (EMA).

A Phase 3 FLASH trial was recently carried out which enrolled a total of 169 patients (166 evaluable) with Stage IA, IB, or IIA CTCL. This trial consisted of three treatment cycles, with an evaluation of 155 patients in the second open-label treatment cycle (Cycle 2) demonstrating that the response rate among the twelve-week treatment group was 40% (p

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By Jane Lee

Jane Lee is a technology journalist who specializes in writing about the latest innovations and trends in the tech industry. She has covered topics such as artificial intelligence, cybersecurity, and cryptocurrency, and has interviewed some of the most influential figures in the tech world. Jane's engaging writing style and her ability to explain technical concepts in simple terms make her a favorite among tech enthusiasts.

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