Soligenix Reports Positive Results from HyBryte™ vs. Valchlor® Study for Cutaneous T-Cell Lymphoma

Soligenix, Inc., a biopharmaceutical company focused on developing treatments for rare diseases, has announced promising results from a study comparing HyBryte™ (synthetic hypericin) with Valchlor® (mechlorethamine gel) in treating cutaneous T-cell lymphoma (CTCL). The study involved 10 patients over a 12-week treatment period, with success defined as a 50% or greater improvement in the cumulative modified Composite Assessment of Index Lesion Severity (mCAILS) score. Results showed that 60% of patients treated with HyBryte™ achieved significant improvement compared to 20% of those treated with Valchlor®. Additionally, HyBryte™ demonstrated a more favorable safety profile.

This open-label study was conducted in Fairport, NY, under the direction of Dr. Brian Poligone, who has previously participated in Phase 2 and 3 studies of HyBryte™. Despite the small sample size and some patients in the HyBryte™ group having more extensive disease, the therapy's rapid onset of action and safety profile were consistent with earlier trials. Dr. Poligone expressed enthusiasm for continuing to support Soligenix in future studies.

Christopher J. Schaber, President and CEO of Soligenix, emphasized that these results bolster previous Phase 3 findings, highlighting the rapid and significant response HyBryte™ can offer within a short treatment period. He noted that HyBryte™'s fast-acting nature and favorable safety profile are advantageous compared to existing treatments for CTCL. Soligenix plans to initiate a confirmatory Phase 3 study (FLASH2) later this year.

The study measured treatment outcomes across 3 to 5 index lesions per patient. After 12 weeks, 60% of HyBryte™ patients reached the "Treatment Success" benchmark, compared to 20% for Valchlor®. Among those not achieving this benchmark, HyBryte™ patients still showed significant improvement, with a 52.5% average cumulative improvement in mCAILS scores compared to 34.7% for Valchlor® patients. Additionally, HyBryte™ was well-tolerated without adverse events, whereas 60% of Valchlor® patients experienced adverse reactions, including rashes and dermatitis.

HyBryte™ operates as a novel photodynamic therapy using synthetic hypericin activated by safe, visible light. This method avoids the risks associated with ultraviolet light and other DNA-damaging treatments. The therapy has shown significant anti-proliferative effects on malignant T-cells and has received orphan drug and fast track designations from the U.S. FDA and orphan designation from the EMA.

The Phase 3 FLASH trial previously enrolled 169 patients with early-stage CTCL, demonstrating HyBryte™'s efficacy and safety. In this trial, a 16% improvement was noted in patients treated with HyBryte™ compared to 4% with placebo. The study's second cycle also revealed a 40% response rate among the 12-week HyBryte™ treatment group, emphasizing the benefits of extended treatment.

An optional third treatment cycle focused on overall safety, with 66% of patients opting to continue. Nearly half of those receiving continuous HyBryte™ treatment throughout all cycles showed a positive response. The therapy's safety profile remained robust, with no systemic absorption or mutagenic effects observed.

Soligenix plans to launch a second Phase 3 trial, FLASH2, before the end of 2024. This randomized, double-blind, placebo-controlled study will enroll approximately 80 subjects, extending continuous treatment to 18 weeks. The trial aims to confirm HyBryte™'s effectiveness over an extended period.

Additionally, the FDA has granted an Orphan Products Development grant to support HyBryte™'s evaluation for CTCL treatment, including home use. This $2.6 million grant over four years was awarded to the University of Pennsylvania, a leading enroller in the Phase 3 FLASH study.

Soligenix continues to advance its specialized biotherapeutics, including expanding synthetic hypericin into psoriasis treatment and developing other therapies for various inflammatory diseases and conditions.