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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 of HyBryte in cutaneous T-cell lymphoma, with interim analysis planned for Q2 2026 and topline data expected in H2 2026.
HyBryte's promising efficacy in treating cutaneous T-cell lymphoma offers hope for patients with rare diseases who currently have limited treatment options available.
Soligenix's novel photodynamic therapy uses safe visible light to treat cancer, achieving nearly double the expected response rate in ongoing clinical 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 slated for the second quarter of 2026, with topline data expected in the second half of 2026.
The overall blinded response rate is 48% among patients who have completed treatment to date, 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.
Soligenix is also developing treatments for psoriasis, inflammatory diseases including oral mucositis in head and neck cancer, Behcet's Disease, and vaccine programs for ricin toxin, filoviruses (Marburg and Ebola), and COVID-19.
Soligenix operates through two business segments: Specialized BioTherapeutics (developing treatments for rare diseases) and Public Health Solutions (developing vaccine programs supported by government funding).
The latest news and updates relating to SNGX are available in the company's newsroom at https://ibn.fm/SNGX
Completing enrollment for the interim analysis represents a major milestone in the Phase 3 study, bringing the company closer to potential regulatory approval and commercialization of HyBryte for cutaneous T-cell lymphoma patients.
Soligenix's Public Health Solutions business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA).
Curated from InvestorBrandNetwork (IBN)
