Soligenix Targets 2026 HyBryte Confirmatory FLASH2 Interim Readout, 18‑Week Endpoint

Soligenix outlines 2026 priorities around HyBryte confirmatory data

FLASH2 confirmatory trial nears planned interim readout

Soligenix is advancing HyBryte (synthetic hypericin) through a confirmatory Phase 3 study dubbed FLASH2, focusing on improving outcomes for patients with early‑stage cutaneous T‑cell lymphoma (CTCL). The company now targets an 80‑patient enrollment and reports 66 patients are enrolled as of Feb. 10, with patient recruitment described as “progressing nicely.” Management anticipates an interim analysis in the second quarter and top‑line results in the second half of 2026.

The FLASH2 protocol largely replicates the design of the first successful Phase 3 FLASH study but shifts the primary endpoint assessment from six weeks to 18 weeks, reflecting evidence that longer HyBryte treatment yields better responses. Soligenix says the overall blinded aggregate response rate remains consistent with its November report and is higher than the response rate used to design the study, strengthening confidence in both the upcoming interim and final outcomes.

Operational focus in 2026 centers on completing enrollment and executing the interim statistical review while preserving trial integrity as a confirmatory study intended to support regulatory and commercial planning. Company leadership frames the 18‑week endpoint and ongoing enrollment as deliberate design choices informed by supportive data and patient responses, with the goal of demonstrating durable benefit from extended topical photodynamic therapy.

Real‑world investigator data support longer treatment duration

An investigator‑initiated open‑label study led by Ellen Kim at the Hospital of the University of Pennsylvania evaluates extended HyBryte treatment up to 54 weeks and provides supporting “real world” evidence. After 18 weeks of continuous therapy in that study, Soligenix reports 75% of evaluable patients achieve “Treatment Success,” with three of eight attaining complete response, findings that reinforce the rationale for the 18‑week primary endpoint in FLASH2.

Company strategy update and stakeholder messaging

Soligenix is also evaluating strategic options, including partnerships and merger and acquisition opportunities, while advancing the FLASH2 trial and broader development plans for rare‑disease dermatology. CEO Dr. Christopher Schaber thanks patients, families and shareholders for their support and underscores 2026 as a pivotal year for clinical milestones and strategic evaluation as the company moves toward confirmatory data readouts.