Soligenix's Commitment to Advancing CTCL Treatments
In preparation for health authority interactions in pursuit of marketing approvals in Europe
Soligenix, Inc. (NASDAQ: SNGX), a biopharmaceutical company dedicated to treating rare diseases with significant unmet needs, has announced the expansion of its European Medical Advisory Board (MAB). This expansion aims to bolster the medical and clinical guidance provided as Soligenix advances its confirmatory Phase 3 multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of HyBryte™ (synthetic hypericin) for treating early-stage cutaneous T-cell lymphoma (CTCL) patients. The trial plans to enroll approximately 80 patients, with top-line results expected in the latter part of 2026.
Insights from New Advisory Board Members
Excitement surrounds the addition of renowned dermatologists, Drs. Julia Scarisbrick and Maarten H. Vermeer, to the European MAB. Soligenix's President and CEO, Christopher J. Schaber, PhD, expressed confidence that their expertise will provide critical insights into the development and approval processes necessary for HyBryte™ in both the European Union and the United Kingdom. The MAB now comprises five esteemed professionals known for their dedication to advancing treatments for CTCL, thus enhancing Soligenix's position in the marketplace as it moves towards commercialization.
The newly formed board is composed of leading specialists with extensive experience in conducting clinical trials and treating CTCL. Their role will include advising on clinical strategy, regulatory interactions with health authorities, and providing invaluable feedback on health economics and reimbursement strategies that could significantly impact patient outcomes.
Meet the European Medical Advisory Board Members
Martine Bagot, MD, PhD – France
Dr. Martine Bagot serves as the Department Head of Dermatology at Hôpital Saint Louis in Paris and holds substantial experience in immunology and oncology, co-authoring over 750 peer-reviewed publications. As Chair of the French Group for the Study of Cutaneous Lymphomas, she possesses extensive insight into dermato-oncology, contributing to major organizations in Europe.
Pietro Quaglino, MD – Italy
Dr. Pietro Quaglino is an Associate Professor at the University of Turin’s Medical School, specializing in melanoma and cutaneous lymphoma. He serves on the board of the Italian Melanoma Intergroup and has authored over 160 scientific publications.
Pablo Luis Ortiz-Romero, MD, PhD – Spain
As Head of the Dermatology Department at Hospital Universitario 12 de Octubre, Dr. Ortiz-Romero leads innovative research into CTCL, holding over 200 publications and significant leadership roles in international dermatology societies.
Julia Scarisbrick, MBhons, ChB, FRCP, MD – United Kingdom
Dr. Scarisbrick oversees the Specialist Cutaneous Lymphoma Service at University Hospital Birmingham. With over 150 publications, she contributes widely to cutaneous lymphoma international consortiums and serves in leadership positions across major dermatology groups.
Maarten H. Vermeer, MD, PhD – The Netherlands
Dr. Vermeer has a profound focus on the pathology and treatment of cutaneous lymphomas, boasting over 175 publications in his field and serving on various significant boards that shape dermatologic research.
About HyBryte™ and Its Novel Treatment Approach
HyBryte™ (research name SGX301) is a groundbreaking treatment utilizing photodynamic therapy that activates the active ingredient, synthetic hypericin, with safe visible light. This innovative approach targets malignant T-cells in skin lesions, offering a safer alternative over traditional therapies often associated with severe side effects. In clinical studies, HyBryte™ evidenced considerable efficacy with minimal risks.
Past trials indicate promising outcomes, with significant responses noted in patients treated with HyBryte™. Notably, a previously published Phase 3 study indicated a response rate of 49% among those who completed treatment cycles, highlighting its potential as a leading option for CTCL patients.
Future Directions and Clinical Trials
Following the initial Phase 3 clinical trial, regulatory feedback indicates that a second Phase 3 trial is critical for attaining marketing approval. This ongoing confirmatory study, titled FLASH2, echoes the successful design of its predecessor while extending treatment durations to enhance efficacy for CTCL management. The anticipated swift enrollment is indicative of Soligenix's proactive engagement with the CTCL patient community and ongoing discussions with regulatory bodies.
In the landscape of CTCL treatment, HyBryte™ emerges not only as a novel therapeutic but also as a beacon of hope for patients facing this challenging condition. With its favorable safety profile and the ongoing commitment to clinical excellence, Soligenix continues to pave the way for innovative solutions that meet pressing patient needs.
Frequently Asked Questions
What is HyBryte™ used for?
HyBryte™ is a photodynamic therapy used to treat early-stage cutaneous T-cell lymphoma (CTCL), targeting malignant T-cells in skin lesions.
Who are the members of the European Medical Advisory Board?
The board includes prominent dermatologists: Martine Bagot, Pietro Quaglino, Pablo Luis Ortiz-Romero, Julia Scarisbrick, and Maarten H. Vermeer.
What are the expected results from the Phase 3 study?
The confirmatory Phase 3 study is aimed at determining the efficacy of HyBryte™ in approximately 80 patients, with anticipated results expected in the second half of 2026.
What sets HyBryte™ apart from other CTCL treatments?
HyBryte™ utilizes synthetic hypericin activated by safe visible light, which reduces the risk of severe side effects typically associated with conventional CTCL therapies.
How does Soligenix support the development of HyBryte™?
Soligenix is committed to advancing the clinical program and obtaining necessary approvals to commercialize HyBryte™, focusing on patient needs and safety.
