April 2025 - Soligenix, a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, provided the following interim report on HyBryte:
Interim results from the ongoing open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage cutaneous T-cell lymphoma (CTCL). Following 18 weeks of treatment, 75% of patients achieved "Treatment Success," reinforcing HyBryte™ as a potentially safe and fast-acting therapy for this chronic and underserved cancer.
The IIS is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study and is the Principal Investigator for the confirmatory Phase 3 FLASH2 study for the treatment of early-stage CTCL. To date, nine patients have been enrolled and treated with HyBryte™ over a time period of up to 54 weeks in the IIS, with all data for the Week 18 timepoint now complete. Consistent with the Phase 3 trials, Treatment Success is predefined as a greater than or equal to 50% improvement in the cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to Baseline. Of the eight patients who could be evaluated through Week 18, six (75%) had a Treatment Success. The 18-week treatment window is the same window that is being evaluated in the FLASH2 double-blind, placebo-controlled, randomized study that is currently enrolling patients. This rapid response is a distinct advantage of HyBryte™ therapy, with many other therapies used in CTCL taking up to six to 12 months to generate a clinically meaningful treatment response. Of these eight evaluable patients through Week 18, four have gone on to complete the 54-week treatment with an average maximum improvement in mCAILS score of 85%, three are still on treatment and one dropped out (due to logistical issues). HyBryte™ appears to be safe and well tolerated in all patients.
"The complete response rates observed, including three patients achieving a complete response on this study to date, as well as the consistent treatment response and safety profile across multiple HyBryte™ clinical studies, has been exciting to see," noted Dr. Kim, Principal Investigator of the IIS. "In the first Phase 3 FLASH study, HyBryte™ was shown to be efficacious with a benign safety profile compared to the current therapies of steroids, chemotherapeutics and ultraviolet light in this chronic orphan disease. With limited treatment options, especially in the early stages of their disease, CTCL patients are often searching for alternative treatments. In our study funded by the U.S. Food and Drug Administration (FDA), initial results evaluating the expanded use of HyBryte™ in a "real world" treatment setting remain very promising, further supporting and extending results from the previous positive Phase 2 and 3 clinical trials. It also provides further confidence to the potential responses we can expect to see in the confirmatory Phase 3 placebo-controlled FLASH2 study. We look forward to continuing to work with the FDA to complete the IIS while we participate in the confirmatory 18-week FLASH2 study."
In late 2024 a study to evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase of cutaneous T-cell lymphoma (mycosis fungoides) is planned to begin. The objective of this Phase 3 clinical trial is to evaluate the ability of an 18-week course of HyBryte and visible light to induce a treatment response in patients with patch/plaque CTCL compared to patients receiving a placebo and visible light.
Learn more about this clinical trial at ClinicalTrials.gov: NCT06470451
To see where the trial is being held, visit HyBryte's clinical trial page on the CL Foundation website.
The FLASH (Fluorescent Light Activated Synthetic Hypericin) study was completed in 2020. Upon the positive completion of the Phase 3 trial, Soligenix will be pursuing a New Drug Application (NDA) filing in the United States for treatment of cutaneous t-cell lymphoma. (1)
1 Soligenix. HyBryte™ Cutaneous T-Cell Lymphoma (CTCL) Treatment. (n.d.). https://www.soligenix.com/pipeline-programs/hybryte-for-cutaneous-t-cell-lymphoma-ctcl/
ClinicalTrials.gov ID: NCT02448381
Sponsor: Soligenix
Brief Summary:
To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
The FLASH (Fluorescent Light Activated Synthetic Hypericin) Study, a phase 3 trial by Soligenix, is a potential new treatment for early stage cutaneous lymphoma using visible fluorescent light. Susan Thornton, CEO, was joined by Drs. Ellen Kim, Chris Pullion and Richard Straube to discuss this exciting technology.
Panelists:
Ellen Kim, MD, Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine
Richard Straub, MD, Chief Medical Officer, Soligenix, Inc.
Chris Pullion, DO, Medical Director, Soligenix Inc.
Positive results were announced earlier this year for the FLASH Study, a phase 3 clinical trial in CTCL, by Soligenix. SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment in comparison to the placebo. SGX301 has received orphan drug and fast track designations from the US Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).
The Cutaneous Lymphoma Foundation's CEO Susan Thornton spoke with Dr. Ellen Kim about clinical trials, and specifically the FLASH [Fluorescent Light Activated Synthetic Hypericin] Study. FLASH is a potential new treatment for early stage cutaneous lymphoma using visible fluorescent light. Dr. Kim is a professor of dermatology at the University of Pennsylvania and a cutaneous lymphoma specialist.
FLUORESCENT LIGHT ACTIVATED SYNTHETIC HYPERICIN (FLASH)
Previously published in the Cutaneous Lymphoma Foundation's Forum 2018 Issue 1 newsletter.
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL) is currently being conducted by Soligenix, Inc. located in Princeton, NJ. Approximately 30 centers across the United States are participating in this trial with several new centers potentially joining the study in the first quarter of 2018. This trial aims to evaluate treatment response to Synthetic Hypericin (the active ingredient in the study drug SGX301) and address the growing demand for topical, skin directed therapies to treat early stage CTCL. The uniqueness of this experimental therapy stems from the photodynamic treatment which incorporates the application of the study ointment in combination with safe, visible fluorescent light as opposed to the more conventional (and potentially harmful) ultraviolet light.
Although the trial is blinded to all patients, clinical study sites and to Soligenix (i.e., no one knows if they getting or giving SGX301 or placebo during the double-blind portion of the study), the response to the study thus far has been very positive from both the patients’ experiences as well as the hospitals and clinics enrolling patients. To date, the study drug has been well tolerated by the patients participating with no serious adverse events related to study drug being reported thus far. Although the trial begins with a double-blind portion, all participants in the trial eventually receive open label SGX301 therapy and if the patients like the response that they see when using the active study drug, a third, optional open label portion of the trial is available to them that allows patients to continue to treat their disease areas with another regimen of SGX301 therapy. Soligenix remains encouraged by the response to this trial and is pleased to report that the majority of patients who have participated in the double-blind portion have elected to continue into the optional open-label portion of this study, which we view as a testimonial to the perceived benefit the patients believe this potential new therapy brings them.
Susan Thornton had the chance to sit down with Dr Rick Straube, Senior VP and Chief Medical Officer of Soligenix, Inc. recently and talk about their clinical trial for treating early stage cutaneous lymphoma. The treatment process uses a new topical photosensitizing agent (synthetic hypericin) and fluorescent light.