Soligenix announces promising results in extended HyBryte treatment study for cutaneous T-cell lymphoma

Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company, has shared an interim update on a key study involving extended HyBryte treatment in patients with early-stage cutaneous T-cell lymphoma (CTCL). This ongoing study, led by Dr. Ellen Kim, MD, of the Hospital of the University of Pennsylvania, showcases promising results with HyBryte therapy over periods extending up to 44 weeks.

The study, known as the investigator-initiated study (IIS), evaluates the efficacy and safety of HyBryte—a novel photodynamic therapy using synthetic hypericin activated by visible light—in managing CTCL. Dr. Kim, a leading figure in the Phase 3 FLASH study, highlighted the encouraging outcomes: 75% of the patients who have completed at least 12 weeks of therapy achieved “Treatment Success,” defined as a 50% or greater improvement in their modified Composite Assessment of Index Lesion Severity (mCAILS) score compared to baseline.

Currently, six patients are enrolled, with three already meeting the treatment success criteria within 12 to 18 weeks of initiation. The remaining patients are in earlier stages of their treatment, with ongoing assessments scheduled. Notably, HyBryte has shown a high safety profile, with no treatment-related adverse events reported.

HyBryte’s approach, which avoids the risks associated with DNA-damaging drugs and UV exposure traditionally used in CTCL treatment, represents a significant advance. The therapy involves applying a topical hypericin ointment to skin lesions, which is then activated by safe, visible light, targeting the malignant T-cells more effectively and with potential to treat deeper skin diseases.

Christopher J. Schaber, President and CEO of Soligenix, emphasized the importance of these findings and the FDA’s support for the study, which allows patients to access HyBryte in a real-world setting. “Following the success of the initial FLASH study, we are encouraged by the sustained positive results over longer treatment periods, underscoring HyBryte’s potential in addressing this challenging orphan disease,” Schaber stated.

The study, designated RW-HPN-MF-01, is set to enroll up to 50 patients across multiple U.S. centers, with treatments extending up to 12 months, including potential for home use. Its primary endpoint is the number of treatment successes defined as at least a 50% reduction in the mCAILS score from baseline.

HyBryte’s development and its promise in the treatment of CTCL is further supported by its receipt of orphan drug and fast track designations from the U.S. FDA, as well as an orphan designation from the European Medicines Agency (EMA).

The innovative use of visible light activation in HyBryte therapy is a groundbreaking approach in the treatment of CTCL, offering a safer and potentially more effective alternative to traditional therapies.