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Soligenix Expands European Medical Advisory Board

Soligenix, Inc., a late-stage biopharmaceutical company, is taking a significant step towards advancing the treatment of cutaneous T-cell lymphoma (CTCL) by expanding its European Medical Advisory Board (MAB). This move is crucial as they prepare for health authority interactions aimed at obtaining marketing approvals in Europe for their novel treatment, HyBryte™ (synthetic hypericin).

Strategic Enhancements to Medical Advisory Board

The recent addition of two esteemed dermatologists, Drs. Scarisbrick and Vermeer, to the European MAB demonstrates Soligenix’s commitment to ensuring expert guidance throughout the clinical development phases of HyBryte™. This board will play an instrumental role as the company conducts a confirmatory Phase 3 clinical trial, which is a critical step in showcasing the efficacy and safety of HyBryte™. In this double-blind, placebo-controlled study, approximately 80 patients with early-stage CTCL will participate, and top-line results are expected in the latter half of 2026.

Christopher J. Schaber, the President and CEO of Soligenix, expressed excitement about the new additions to the MAB, highlighting that having prominent experts contribute to the development of HyBryte™ is vital for its success in both the European Union (EU) and the United Kingdom (UK). This expansion exemplifies Soligenix's strategic approach in combining deep clinical expertise with regulatory navigating to reach patients with unmet medical needs effectively.

The Role of the Expanded Medical Advisory Board

The inclusion of members with international renown ensures a wealth of knowledge and experience focused on the clinical research of CTCL. These esteemed professionals will provide critical feedback regarding clinical strategies, health economics, and reimbursement practices in order to guide Soligenix in meeting the needs of patients suffering from CTCL.

Notable members joining the advisory board include:

• - Martine Bagot, MD, PhD (France): Professor and Head of the Department of Dermatology at Hôpital Saint Louis, Paris. Dr. Bagot’s extensive research in dermato-oncology includes over 750 peer-reviewed publications.
• - Pietro Quaglino, MD (Italy): Associate Professor of Dermatology from the University of Turin, focused on melanoma and cutaneous lymphomas, with over 160 scientific publications credited to his name.
• - Pablo Luis Ortiz-Romero, MD, PhD (Spain): Head of the Dermatology Department at Hospital Universitario 12 de Octubre, specializing in CTCL with over 200 publications relating to innovative treatments.
• - Julia Scarisbrick, MBhons, ChB, FRCP, MD (UK): Leading the Specialist Cutaneous Lymphoma Service at University Hospital Birmingham, Dr. Scarisbrick’s focus on clinical and molecular research has led to significant advancements in CTCL treatment.
• - Maarten H. Vermeer, MD, PhD (Netherlands): Head of Dermatology at Leiden University Medical Center, with extensive research experience in identifying diagnostic markers for cutaneous lymphomas.

About HyBryte™ and CTCL

HyBryte™, known in research circles as SGX301, represents a novel approach to photodynamic therapy that utilizes synthetic hypericin as a topical treatment. This method activates potential therapeutic properties via safe visible light application, which has shown promising results in previous clinical trials.

The treatment targets malignant T-cells associated with CTCL, allowing deeper penetration into the skin while minimizing the risks of secondary malignancies often linked with other UV-based therapies. Previous studies have indicated statistically significant improvements for patients treated with HyBryte™, showcasing its effectiveness without the damaging side effects associated with traditional therapies.

CTCL, a rare form of Non-Hodgkin's Lymphoma, affects the skin through malignant T-cell proliferation. It presents a significant challenge in oncology with varying degrees of severity, where early-stage detection is crucial. The mortality rate associated with advanced stages of CTCL can spike dramatically, motivating the need for effective treatment options.

Looking Forward

With the expansion of their advisory board, Soligenix is poised to address the challenges posed by CTCL more effectively. The groundwork for the second Phase 3 clinical study is firmly in place as they gather feedback from their esteemed advisors and chart a path toward potential commercialization. This collaborative effort could change the landscape for CTCL treatment, providing patients with safer and more effective options going forward.

As Soligenix continues to navigate this path, there is an air of optimism surrounding HyBryte™ as it moves closer to fulfilling a critical need for patients living with CTCL. By developing innovative solutions that emphasize safety and efficacy, Soligenix reaffirms its commitment to addressing significant unmet medical needs in the realm of rare diseases.