HyBryte Achieves 60% Success Rate vs Valchlor’s 20% with No Adverse Events
Soligenix reported that HyBryte achieved 60% treatment success in a 12-week comparability study versus Valchlor’s 20%, with no treatment-related adverse events compared to multiple reactions for Valchlor. These positive Phase 3-comparable results bolster HyBryte’s positioning for regulatory approval filings to treat early-stage cutaneous T-cell lymphoma worldwide.
1. Positive Comparability Study Outcomes
Soligenix announced that in a 12-week head-to-head study, 60% of HyBryte-treated patients achieved treatment success versus 20% for Valchlor, demonstrating a markedly improved efficacy profile for early-stage cutaneous T-cell lymphoma.
2. Superior Safety and Tolerability
HyBryte patients reported zero treatment-related adverse events, while Valchlor recipients experienced multiple reactions, underscoring HyBryte’s potential as a well-tolerated photodynamic therapy option.
3. Regulatory and Commercial Outlook
Following completion of its second Phase 3-comparable study, Soligenix plans to pursue global regulatory filings for HyBryte, aiming for commercialization in a niche CTCL market with limited approved treatments.