Soligenix Launches European Advisory Board for Phase 3 HyBryte CTCL Trial

Image Credit: © Te Whatu Ora, DermNet

Soligenix, Inc. recently unveiled new initiatives to advance HyBryte (synthetic hypericin) for cutaneous T-cell lymphoma (CTCL).¹

At the forefront of these efforts is the establishment of a European Medical Advisory Board (MAB), comprised of leading dermatologists and CTCL researchers, to guide the development and implementation of the upcoming phase 3 FLASH2 clinical trial.

The European MAB consists of distinguished experts in cutaneous lymphomas, including: Martine Bagot, MD, PhD, chair of the French Group for the Study of Cutaneous Lymphomas and a pioneer in research on mycosis fungoides; Pietro Quaglino, MD, a respected researcher in melanoma and cutaneous lymphomas; and Pablo Luis Ortiz-Romero, MD, PhD, known for his expertise in mycosis fungoides and Sézary syndrome.

This advisory board will ensure that FLASH2 aligns with European regulatory standards and incorporates regional insights to optimize trial outcomes.

"We consider expert European involvement a necessary component for the development of this program. As such, it is an honor to have such a prestigious and dedicated group of clinicians and leaders in the field committed to working with us as we develop HyBryte," said Christopher Schaber, PhD, president and CEO of Soligenix, in a news release.¹ "The support of these European experts is a further testament to the opportunity HyBryte could provide for patients suffering from this disease worldwide."

The phase 3 FLASH2 trial builds on the success of the original FLASH trial (NCT02448381), which confirmed the safety and efficacy of HyBryte for early-stage CTCL. FLASH2 will extend the treatment period to 18 weeks, aiming to better replicate real-world use.

This double-blind, placebo-controlled study will enroll approximately 80 patients across the US and Europe. Participants will receive topical HyBryte twice weekly, followed by visible light exposure, with the primary endpoint measuring reductions in the modified Composite Assessment of Index Lesion Severity score.²

HyBryte employs visible light to activate synthetic hypericin, a topical agent targeting malignant T-cells in the skin. Clinical studies, including the FLASH trial conducted from 2015 to 2020, have demonstrated HyBryte’s effectiveness in reducing lesion severity.³

The FLASH trial involved 169 adults with stage IA to IIA mycosis fungoides. Participants received 6 weeks of treatment in three cycles, with the first cycle placebo-controlled. Results showed significant lesion improvement, enhanced by additional treatment cycles. HyBryte was effective across all lesion types and exhibited a benign safety profile, free from the severe risks linked to many existing CTCL therapies.

In addition to CTCL, Soligenix is investigating HyBryte for conditions like mild-to-moderate psoriasis. Early studies suggest potential for broader therapeutic use.⁴

If the FLASH2 trial is successful, HyBryte could become a safe, effective, and accessible option for patients worldwide, addressing unmet needs in this condition.

References

1. Soligenix Announces Formation of European Medical Advisory Board for Cutaneous T-Cell Lymphoma. News release. Soligenix. November 19, 2024. Accessed November 20, 2024. https://ir.soligenix.com/2024-11-19-Soligenix-Announces-Formation-of-European-Medical-Advisory-Board-for-Cutaneous-T-Cell-Lymphoma
2. Soligenix announces agreement on the design of a second confirmatory placebo-controlled trial for HyBryte with the European Medicines Agency. News release. PR Newswire. April 3, 2024. Accessed November 20, 2024. https://www.prnewswire.com/news-releases/soligenix-announces-agreement-on-the-design-of-a-second-confirmatory-placebo-controlled-trial-for-hybryte-with-the-european-medicines-agency-302106263.html.
3. Positive clinical results from HyBryte compatibility study in the treatment of cutaneous T-cell lymphoma published in JEADV Clinical Practice. News release. PR Newswire. May 16, 2024. Accessed November 20, 2024. https://www.prnewswire.com/news-releases/positive-clinical-results-from-hybryte-compatibility-study-in-the-treatment-of-cutaneous-t-cell-lymphoma-published-in-jeadv-clinical-practice-302146956.html
4. Soligenix announces top-line results of the phase 2a study of SGX302 (synthetic hypericin) in patients with mild-to-moderate psoriasis. News release. PR Newswire. January 4, 2024. Accessed November 20, 2024. https://www.prnewswire.com/news-releases/soligenix-announces-top-line-results-of-the-phase-2a-study-of-sgx302-synthetic-hypericin-in-patients-with-mild-to-moderate-psoriasis-302025994.html#:~:text=Synthetic%20hypericin%20or%20HyBryte%E2%84%A2,caused%20by%20malignant%20T%2Dcells