Soligenix Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company developing treatments for rare diseases, announced the completion of enrollment for the 50 patients required for the interim analysis in its confirmatory Phase 3 FLASH2 study evaluating HyBryte (synthetic hypericin sodium) in cutaneous T-cell lymphoma (CTCL). The interim analysis is expected to occur in the second quarter of 2026, with topline data anticipated in the second half of the year.
The company reported that the overall blinded response rate among patients who have completed treatment to date is 48 percent, significantly exceeding the anticipated 25 percent rate used in the study's powering assumptions. Investigators noted safety findings consistent with earlier studies, with HyBryte continuing to demonstrate encouraging efficacy signals across the ongoing development program. The FLASH2 study is an 80-patient confirmatory trial designed to support regulatory approvals for HyBryte as a novel photodynamic therapy using safe visible light for the treatment of CTCL.
HyBryte is part of Soligenix's Specialized BioTherapeutics business segment, which also includes expansion of synthetic hypericin (SGX302) into psoriasis and other programs such as dusquetide (SGX942) for oral mucositis and SGX945 for Behcet's Disease. The company's Public Health Solutions segment includes vaccine programs for ricin, filoviruses, and COVID-19, supported by government funding from NIAID, DTRA, and BARDA.
For more information, the full press release is available at https://ibn.fm/uxz52. Additional updates on Soligenix are available in the company's newsroom at https://ibn.fm/SNGX.
