Synthetic Hypericin Expanded Treatment Study in Cutaneous T-Cell Lymphoma Opens Enrollment

Soligenix, Inc has announced¹ that enrollment is now open for its expanded treatment study investigating the use of HyBryte, or synthetic hypericin, for the treatment of cutaneous T-cell lymphoma.

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The investigator-initiated study (IIS) is supported by an Orphan Products Development grant awarded by the US Food and Drug Administration (FDA) for expanded treatment studies and in the home use setting. To be conducted at the University of Pennsylvania, the study will evaluate the expanded treatment of synthetic hypericin in patients with early-stage cutaneous T-cell lymphoma (CTCL) over an up to 12-month trial period.

The clinical study, “Assessment of Treatment with Visible Light Activated Synthetic Hypericin Ointment in Mycosis Fungoides Patients,” (RW-HPN-MF-01) will build off the phase 3 Fluorescent Light Activated Synthetic Hypericin (FLASH) trial,² wherein 166 evaluable patients with stage IA, IB, or IIA CTCL underwent 3 treatment cycles with HyBryte synthetic hypericin or a placebo. Approximately 49% of patients who underwent all 3 cycles of treatment demonstrated positive treatment response when compared to patients receiving the placebo.

"In the Phase 3 FLASH study, HyBryte was shown to be efficacious with a promising safety profile. CTCL patients are often searching for alternative treatments, with limited options especially for early-stage disease,” said Ellen Kim, MD, in a press release¹ from Soligenix.

Kim is the director of the Penn Cutaneous Lymphoma Program, vice chair of Clinical Operations in the school’s dermatology department, and a professor of dermatology at the Hospital of the University of Pennsylvania. Kim is also the sponsor of this expanded treatment study and was the lead enroller of the FLASH study.

“We look forward to demonstrating the expanded use of HyBryte in a ‘real world’ setting,” Kim said.

In the FLASH study, patients experienced statistically significant symptom improvement when treated with topical hypericin. The novel, first-in-class therapy contains a topical photosensitizer that is activated with red-yellow spectrum light for deep penetration into the skin.

“HyBryte's mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects,” according to the press release from Soligenix.¹ “Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available.”

At this time, HyBryte has received fast track and orphan drug designations from the FDA and orphan drug designation from the European Medicines Agency.

References

1. Soligenix Inc. HyBryte expanded treatment trial in cutaneous T-cell lymphoma opens enrollment. PR Newswire: press release distribution, targeting, monitoring and marketing. August 10, 2023. Accessed August 10, 2023. https://www.prnewswire.com/news-releases/hybryte-expanded-treatment-trial-in-cutaneous-t-cell-lymphoma-opens-enrollment-301895544.html.
2. Kim EJ, Mangold AR, DeSimone JA, et al. Efficacy and safety of topical hypericin photodynamic therapy for early-stage cutaneous t-cell lymphoma (mycosis fungoides): the FLASH phase 3 randomized clinical trial. JAMA Dermatol. 2022;158(9):1031–1039. doi:10.1001/jamadermatol.2022.2749