Innovative European Medical Advisory Board Established for CTCL

Soligenix Introduces European Medical Advisory Board

Soligenix, Inc. (NASDAQ: SNGX), a leading biopharmaceutical company at the forefront of developing and commercializing treatments for rare diseases, has announced the formation of a specialized European Medical Advisory Board (MAB). This initiative aims to provide invaluable clinical guidance as the company progresses towards a confirmatory Phase 3 clinical study for its innovative product, HyBryte™. This key study is focused on patients with early-stage cutaneous T-cell lymphoma (CTCL).

Focus on HyBryte™ and Clinical Studies

HyBryte™ (research name SGX301) is a groundbreaking photodynamic therapy that uses synthetic hypericin and safe, visible light to activate the treatment within the skin. The planned Phase 3 study will involve approximately 80 patients spanning multiple centers across Europe and the U.S., set to begin enrollment by the end of the year. Top-line results from this extensive study are anticipated in 2026.

Expertise Behind the Advisory Board

The newly formed MAB brings together an esteemed group of leading dermatologists and researchers renowned for their expertise in CTCL. This collaboration comes on the heels of valuable feedback received from the European Medicines Agency (EMA) regarding the study's design. Soligenix’s CEO, Christopher J. Schaber, PhD, expressed gratitude for the involvement of these distinguished European clinicians, stating that their collective experience and insight will be pivotal in advancing HyBryte's™ potential role in treating patients globally.

Understanding Cutaneous T-Cell Lymphoma

As a subtype of non-Hodgkin's lymphoma, CTCL manifests through the abnormal proliferation of T-cell lymphocytes in the skin. The disease often starts with patches that can escalate to more severe skin manifestations, including plaques and tumors. Treatment options for CTCL remain limited, making it critical for advancements in therapies like HyBryte™ to emerge for enhancing patient outcomes. Currently, CTCL affects around 31,000 individuals in the U.S., emphasizing the need for effective treatment solutions.

European MAB Members

The European MAB includes distinguished figures such as Dr. Martine Bagot from France, Dr. Pietro Quaglino from Italy, and Dr. Pablo Luis Ortiz-Romero from Spain. These experts bring decades of research and clinical experience, having led numerous studies and trials aimed at improving treatment for CTCL. Their input will guide Soligenix throughout the clinical trial process, focusing on strategic clinical planning and regulatory interactions.

The Innovation Behind HyBryte™

HyBryte™ represents a significant innovation in CTCL treatment, using a unique mechanism that bypasses typical DNA-damaging pathways associated with traditional therapies. This novel approach might present a safer profile for patients, particularly given common treatments' association with severe side effects, including the risk of secondary malignancies. The evidence from a Phase 2 clinical trial suggests statistically significant improvements with the use of HyBryte™, which could mean new hope for patients struggling with this rare condition.

Pivotal Clinical Trials and Future Directions

The forthcoming FLASH2 study aims to replicate the success of previous trials while addressing regulatory feedback. Both the FDA and EMA have emphasized the importance of securing successful trial outcomes to support eventual approval. Soligenix’s commitment to patient safety and treatment efficacy will guide this process as they strategize for expanded applications of HyBryte™, including the potential home-use treatment for patients.

About Soligenix, Inc.

Soligenix is dedicated to addressing unmet medical needs by developing and commercializing new treatments for rare diseases, particularly CTCL and other dermatological conditions. Alongside HyBryte™, Soligenix is also advancing various projects targeting inflammatory diseases and vaccines for public health threats. This holistic approach underscores the company’s commitment to innovating within the healthcare landscape, aiming for broader patient access and safety.

Frequently Asked Questions

What is the role of the European Medical Advisory Board (MAB)?

The MAB provides strategic clinical guidance and expertise to enhance the development of HyBryte™ for treating CTCL.

What is HyBryte™?

HyBryte™ is a novel photodynamic therapy that utilizes safe, visible light and synthetic hypericin to treat cutaneous T-cell lymphoma.

When will the FLASH2 clinical study begin?

The FLASH2 study is anticipated to start by the end of the year as part of the ongoing developmental efforts for HyBryte™.

Who are the members of the European MAB?

The MAB consists of leading physicians and researchers from renowned institutions across Europe, specializing in CTCL.

What makes HyBryte™ a safer option for CTCL treatment?

HyBryte™ avoids DNA damage, significantly reducing the risk of severe side effects commonly associated with existing CTCL therapies.

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