Positive Clinical Results for HyBryte™ Compared to Valchlor® in Cutaneous T-Cell Lymphoma

HyBryte™ demonstrates more rapid and robust treatment response in 12-week study

Apr. 2, 2026 at 12:55pm

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Soligenix, Inc. announced that positive results from a comparative study evaluating its HyBryte™ treatment against Valchlor® for cutaneous T-cell lymphoma (CTCL) have been published in Oncology and Therapy. The study found that 60% of HyBryte™ patients met the criteria for "Treatment Success" compared to only 20% of Valchlor® patients, although the small sample size did not achieve statistical significance. HyBryte™ also demonstrated a higher average improvement in lesion severity scores and was better tolerated than Valchlor®.

Why it matters

The results highlight the potential benefits of HyBryte™ as a new treatment option for CTCL, a rare and difficult-to-treat form of non-Hodgkin's lymphoma. With its rapid onset of action and favorable safety profile compared to existing therapies, HyBryte™ could provide an important new tool for managing this disease.

The details

The 12-week study enrolled a small number of patients with early-stage CTCL and compared the safety and efficacy of HyBryte™ (synthetic hypericin) versus Valchlor® (mechlorethamine). Despite the HyBryte™ group having patients with more extensive disease, 60% of those patients met the criteria for "Treatment Success" (≥50% improvement in lesion severity) compared to only 20% of Valchlor® patients. The average improvement in lesion severity was also higher in the HyBryte™ group at 52.5% versus 34.7% in the Valchlor® group. Importantly, all HyBryte™ patients tolerated the treatment well, while 60% of Valchlor® patients experienced adverse events related to the therapy, with one patient requiring permanent discontinuation.

  • The study was published in Oncology and Therapy on April 2, 2026.

The players

Soligenix, Inc.

A late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases.

Brian Poligone, MD, PhD

Director of the Rochester Skin Lymphoma Medical Group and Principal Investigator for the HyBryte™ vs. Valchlor® comparative study.

HyBryte™

Soligenix's novel photodynamic therapy utilizing safe, visible light for the treatment of cutaneous T-cell lymphoma.

Valchlor®

An approved drug for the treatment of cutaneous T-cell lymphoma.

Oncology and Therapy

The international, open access, peer-reviewed journal that published the results of the HyBryte™ vs. Valchlor® comparative study.

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What they’re saying

“Being able to share the important results of this clinical trial with the world through publication in Oncology and Therapy is a privilege and highlights the clinical significance of our work with HyBryte™.”

— Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, and Principal Investigator for the comparability study

What’s next

Soligenix is currently conducting a second, confirmatory Phase 3 study of HyBryte™ called FLASH2, which is expected to complete a blinded interim analysis in the second quarter of 2026. The company is also in discussions with the FDA on the development path for HyBryte™, including the potential for modifications to address the agency's feedback.

The takeaway

The positive results from this comparative study, combined with HyBryte™'s favorable safety profile, suggest it could provide an important new treatment option for patients with cutaneous T-cell lymphoma, a rare and challenging disease. The continued development of HyBryte™ represents an important step forward in addressing the unmet medical needs of this patient population.