HyBryte(TM): Addressing an Unmet Need for Rare Lymphoma

Soligenix Demonstrates Clinical Success in First-in-Class Treatment for Cutaneous T-Cell Lymphoma

New York, New York--(Newsfile Corp. - July 22, 2021) - PCG Digital -- Cutaneous T-cell lymphoma (CTCL) is a rare form of non-Hodgkin's lymphoma that currently affects between 16,000 - 20,000 Americans, with approximately 1,000 new diagnoses each year. There is currently no FDA-approved first line treatment for CTCL, leaving clinicians and patients reliant on traditional phototherapy treatments.

Soligenix (NASDAQ: SNGX), a biopharmaceutical company specializing in treatments for rare diseases, is addressing this unmet need for those living with CTCL.

HyBryte™ (synthetic hypericin) offers a less invasive photodynamic therapy, using safe, visible light to treat early-stage CTCL. Soligenix recently conducted a Phase 3 FLASH trial of HyBryte™, demonstrating safety, tolerability and efficacy and positioning HyBryte™ as a safer short- and long-term treatment option for CTCL patients.

Dr. Ellen Kim, the Lead Principal Investigator for the study and Medical Director of the Dermatology Clinic for the Perelman Center for Advanced Medicine, presented at the United States Cutaneous Lymphoma Consortium (USCLC) Annual Meeting this month, summarizing the HyBryte™ FLASH trial.

Dr. Kim said, "We're looking for treatment options with efficacy, but also short-term and long-term safety. Because there are no curable treatment options for CTCL, we manage this disease like we manage other chronic conditions. HyBryte™ is a safe and effective option for that.

"The response rate peaked at 49 percent which is quite typical for the sort of response for many skin-directed therapies currently approved for CTCL. What's gratifying is that HyBryte™ has a really great safety profile."

About the Phase 3 FLASH study for HyBryte:

  • The HyBryte study was a multi-center randomized control blinded trial held in the US.
  • HyBryte is a synthetic hypericin ointment that can be combined with visible light to treat early-stage mycosis fungoides CTCL.
  • The study was conducted in three cycles, with the first cycle randomizing patients in a blinded manner between placebo and the active drug. Cycle 2 was the crossover cycle where all patients received HyBryte™ and Cycle 3 was optional to treat all lesions. Response rate was measured at the end of each cycle.
  • Each cycle was six weeks long, with two treatments per week, followed by a two-week rest period before results were measured. 169 patients were enrolled in the study.
    • Cycle 1 produced a 16% response rate in active drug recipients
    • Cycle 2 produced a 40% response rate from patients who received two cycles of HyBryte™ (Cycle 1 and Cycle 2)
    • Cycle 3 produced a 49% response rate
  • The response rate is comparable to other skin-directed therapies studied and the safety profile was excellent, with responses seen in both patch and deeper plaque lesions. Other therapies have limitations with regards to short-term and long-term side effects.
  • Minimal adverse effects were seen in 16% of patients. 1.7% discontinued the trial due to adverse side effects, which included erythema, hyperpigmentation, and itching.
  • Due to the use of visible light that penetrates deeper versus traditional ultraviolet A or B phototherapy, there was no difference in response rate between dark and light-skinned patients.

Watch the full presentation here : HERE

To find out more, visit HyBryte.com.

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