Soligenix has scrapped its cutaneous T-cell lymphoma (CTCL) program in the wake of a phase 3 setback, leaving the biotech focused on another rare disease prospect and considering strategic alternatives.
A data monitoring committee recommended Soligenix end the CTCL trial in April. The recommendation reflected an interim review of phase 3 efficacy data that found the study was unlikely to succeed. At the time, Soligenix began evaluating strategic options but held off on making a decision about the future of its CTCL candidate, HyBryte. Last month, the biotech said it was still assessing why the trial flopped.
The company’s board reached a decision late last week, concluding that ending HyBryte development is in the best interests of the business and its shareholders. Soligenix expects to pay about $70,000 to wind down the program, with most of the money being used to close out the clinical trial.
Soligenix started the phase 3 trial after the FDA issued a refusal-to-file letter in response to the biotech’s request for approval. The company filed for approval based on a phase 3 trial that hit its primary goal, but the FDA found the submission incomplete and requested data from a second study. Soligenix started the confirmatory trial in 2025 and, according to ClinicalTrials.gov, was set to finish the study this year.
The program studied a synthetic form of hypericin that Soligenix identified as a way to treat the lesions that form on the skin of people with CTCL. Physicians apply HyBryte to skin lesions and use fluorescent light to activate the photosensitizer. Studies suggested the approach may cause cell death, inhibiting the growth of malignant T cells and treating lesions.
With the confirmatory trial failing to deliver the hoped-for data, Soligenix has switched its attention to pipeline assets including dusquetide. The biotech designed the synthetic peptide to regulate the innate immune system, reducing inflammation, eliminating infection and enhancing tissue healing. Soligenix completed a phase 2a trial of the asset in the rare inflammatory disorder Behçet’s disease last year.
Investors assign little value to the program. Soligenix, which ended March with $6 million in cash, has a market cap of $6.4 million. The biotech forecasts its cash will support operations into the second quarter of next year. Soligenix plans to use the time to look into strategic options, including merger and acquisition opportunities.