HyBryte™ Treatment Results to be Presented at US Cutaneous Lymphoma Consortium Annual Workshop 2026

Highlighting Positive Results in Comparison to Valchlor® and in Real-World Use

PRINCETON, N.J., March 23, 2026 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that findings from recent supportive trials with HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) are being presented at the United States Cutaneous Lymphoma Consortium (USCLC) Workshop (March 26, 2026), which precedes the American Academy of Dermatology (AAD) Annual Meeting. 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 the Principal Investigator for the first Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study as well as the ongoing Phase 3 FLASH2 study, will present at the USCLC. Dr. Kim will detail positive results from the recently completed investigator-initiated study using HyBryte™ as a long-term treatment of CTCL. A poster also will be presented at the conference sharing the positive results of a study evaluating HyBryte™ versus Valchlor® (mechlorethamine) conducted by Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group and Principal Investigator for the comparability study. The official conference program can be found here.

Oral Presentation:

Title: Phase 2 Investigator-Initiated Real-World Study Evaluating Topical Hypericin Ointment Photodynamic Therapy for Early-Stage Mycosis Fungoides/CTCL (RW-HPN-MF-01) presented by Dr. Ellen Kim, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania.              

Poster Presentation:

Title: Results from a Pilot Study of HyBryte™ (topical synthetic hypericin) versus Valchlor® (mechlorethamine) in the Treatment of CTCL attended by Dr. Christopher Pullion, Medical Director, Soligenix, Inc.

The poster and presentation review the Company's findings in recent supportive studies, which have demonstrated the clinical benefits of longer treatment times (Study RW-HPN-MF-01; investigator-initiated study), as well as  HyBryte's™ relative efficacy and tolerability compared to Valchlor® (Study HPN-CTCL-04).

About the USCLC Workshop

The United States Cutaneous Lymphoma Consortium is a multidisciplinary society of physicians which use collaborative research and education to improve the quality of life and prognosis of patients with cutaneous lymphoma. This workshop is held annually to facilitate collaboration. The meeting website is available here.

About the AAD Annual Meeting

The American Academy of Dermatology Association Annual Meeting is one of the largest dermatologic scientific meetings globally and is attended by both researchers and dermatologists. The meeting website is available here.

About HyBryte™

HyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte™ has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

The published Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle (Cycle 1), 116 patients received HyBryte™ treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the modified Composite Assessment of Index Lesion Severity [mCAILS] score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte™ treatment in this cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte™ treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte™ treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte™ treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p