HyBryte™ demonstrates more rapid and robust treatment response compared to

Valchlor® during 12-week treatment course

PRINCETON, N.J., April 2, 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 the positive results of its comparability study evaluating HyBryte™ (synthetic hypericin) versus Valchlor® (mechlorethamine) for the treatment of cutaneous T-cell lymphoma (CTCL) have been published in Oncology and Therapy. 

The purpose of the study was to obtain preliminary comparative assessment of the safety and efficacy of HyBryte™ versus Valchlor® following 12 weeks of treatment as measured in 3 to 5 prospectively identified index lesions for each patient. At the end of the 12-week treatment period, 60% of the HyBryte™ patients met the prospectively defined level of "Treatment Success" (≥50% improvement in their cumulative mCAILS score compared to Baseline) compared to only 20% of the Valchlor® patients; although due to the small sample size the results do not achieve statistical significance. Of the remaining two HyBryte™ patients that did not achieve treatment success, both saw a substantial (≥30%) reduction in their mCAILS score. In contrast, in the Valchlor® group, of the remaining 4 patients that did not achieve treatment success, one worsened and dropped from the study, one improved less than 30% and two improved greater than 30%. The average cumulative improvement in mCAILS at 12 weeks was 52.5% in the HyBryte™ patients versus 34.7% in the Valchlor® patients. HyBryte™ was well tolerated in all patients whereas 1 of the 5 patients receiving Valchlor® had to be withdrawn from the trial because of a clinically significant allergic contact dermatitis from Valchlor®.

When comparing the tolerance of the topical therapies (i.e., reactions where the drug was applied to the skin) in this trial, it is notable that all patients tolerated HyBryte™ well and had no adverse events "related" to the therapy. In contrast, 60% of the Valchlor® treated patients had at least one adverse event "related" to the therapy. These adverse events in the Valchlor® group included rashes, application site sensitivity, allergic contact dermatitis, and dermatitis, with one patient requiring steroid treatment, one requiring temporary interruption of Valchlor® treatment, and one requiring permanent discontinuation of Valchlor®. No such instances were reported in the HyBryte™ group.