Soligenix Focuses 2026 on HyBryte Confirmatory Phase 3 (FLASH2) and Strategic Partnerships

Soligenix makes HyBryte the center of its 2026 strategy

Soligenix, a late‑stage biopharmaceutical company focused on rare diseases, is concentrating 2026 efforts on advancing HyBryte (SGX301, synthetic hypericin) through a pivotal confirmatory Phase 3 trial and evaluating strategic partnerships and corporate options. In a letter to shareholders, President and CEO Dr. Christopher Schaber frames the year as one of clinical milestones and business development, saying progress in the FLASH2 study and supporting data inform the company’s near‑term decisions.

FLASH2 confirmatory trial advances with design shaped by extended‑treatment data

The company is actively enrolling the 80‑patient FLASH2 (Fluorescent Light And Synthetic Hypericin 2) confirmatory Phase 3 study in early‑stage cutaneous T‑cell lymphoma (CTCL), with 66 patients enrolled as of Feb. 10. FLASH2 largely replicates the first successful Phase 3 FLASH study but shifts the primary endpoint assessment from six weeks to 18 weeks based on evidence that longer HyBryte treatment yields improved response rates. Management states this design change aims to capture the full therapeutic effect observed in longer treatment courses.

Soligenix reports the overall blinded aggregate response rate in FLASH2 remains consistent with the company’s November update and is higher than the response rate used to power the trial, which the company says bolsters confidence in both the planned interim and final outcomes. An interim analysis is expected in the second quarter of 2026, with top‑line results anticipated in the second half of the year, milestones the company highlights as pivotal for confirming HyBryte’s activity in this patient population.

Management underscores operational momentum and patient enrollment pacing

The company emphasizes that enrollment is progressing well and that the approaching interim readout reinforces management optimism about meeting its timelines. Dr. Schaber thanks patients, families and supporters, noting that the cumulative dataset from FLASH and other studies influenced FLASH2’s longer assessment window and bolstered the program’s rationale.

Supportive investigator data and strategic review continue in parallel

Separately, an investigator‑initiated open‑label study led by Dr. Ellen Kim at the Hospital of the University of Pennsylvania evaluates extended HyBryte treatment for up to 54 weeks. After 18 weeks of continuous “real‑world” therapy, the study reports 75% of evaluable patients achieve “Treatment Success,” with three of eight attaining complete response, data Soligenix cites as supportive of extended treatment benefits.

While advancing FLASH2, Soligenix is also evaluating strategic options including potential partnerships and merger and acquisition opportunities to support development and commercialization efforts. The company reiterates 2026 as an important year for both clinical progress and strategic evaluation.