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FAQ: Soligenix Completes Enrollment for HyBryte Phase 3 FLASH2 Study in Cutaneous T-Cell Lymphoma
TL;DR
Soligenix's HyBryte shows 48% response rate in CTCL trial, exceeding expectations and positioning it as a potential market leader in rare disease treatment.
Soligenix completed enrollment for its Phase 3 FLASH2 study interim analysis, with data expected in 2026 following a blinded 48% response rate in CTCL patients.
HyBryte's promising results offer new hope for cutaneous T-cell lymphoma patients, potentially improving quality of life for those with rare diseases.
Soligenix's novel photodynamic therapy uses safe visible light to treat CTCL, showing nearly double the expected response rate in ongoing trials.
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Soligenix has completed enrollment of the 50 patients required for interim analysis in its Phase 3 FLASH2 study evaluating HyBryte for the treatment of cutaneous T-cell lymphoma.
HyBryte is a novel photodynamic therapy that uses safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL), a rare disease with unmet medical need.
The interim analysis is scheduled for the second quarter of 2026, with topline data expected in the second half of 2026.
The study has shown an overall blinded response rate of 48% among patients who have completed treatment, which exceeds the anticipated 25% rate used in the study's powering assumptions.
Investigators report safety findings consistent with earlier studies, with HyBryte continuing to demonstrate encouraging efficacy signals across the ongoing development program.
With successful completion of the second Phase 3 study, Soligenix will seek regulatory approvals to support potential commercialization of HyBryte worldwide.
Soligenix has development programs including synthetic hypericin for psoriasis, dusquetide for inflammatory diseases, vaccine candidates for ricin toxin, filoviruses, and COVID-19, utilizing their proprietary ThermoVax heat stabilization technology.
The latest news and updates relating to SNGX are available in the company's newsroom at https://ibn.fm/SNGX
The 48% blinded response rate significantly exceeds the 25% rate anticipated in the study's powering assumptions, suggesting stronger than expected efficacy for HyBryte in treating cutaneous T-cell lymphoma.
Curated from InvestorBrandNetwork (IBN)

