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FAQ: Soligenix's CTCL Therapy Safety Milestone and Clinical Program Update
TL;DR
Soligenix's HyBryte therapy cleared a major safety milestone, positioning it ahead in the rare disease market with potential regulatory and commercial advantages.
The Data Monitoring Committee confirmed no safety issues in Soligenix's Phase 3 FLASH2 trial, which enrolls 80 CTCL patients and builds on prior Phase 3 data.
This safety milestone advances a novel therapy for cutaneous T-cell lymphoma, offering hope for patients with rare diseases and unmet medical needs.
Soligenix's HyBryte uses synthetic hypericin in a skin-directed approach for CTCL, marking an innovative step in biotechnology for rare cancers.
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Soligenix announced that the Data Monitoring Committee overseeing its Phase 3 FLASH2 trial of HyBryte™ has reported no safety concerns to date, affirming the therapy's safety profile for early-stage cutaneous T-cell lymphoma (CTCL).
This milestone is significant because regulatory pathways for orphan diseases like CTCL often depend on establishing a favorable safety profile, and clearing this safety hurdle allows the company to shift focus more explicitly to efficacy and regulatory strategy.
HyBryte™ (synthetic hypericin) is Soligenix's lead therapy being developed as a novel skin-directed treatment for early-stage cutaneous T-cell lymphoma (CTCL), specifically for patients with patch or plaque phase disease.
The FLASH2 trial is Soligenix's confirmatory Phase 3 clinical trial that builds on the earlier Phase 3 FLASH trial and will enroll approximately 80 subjects with early-stage CTCL.
Soligenix is advancing toward critical milestones in 2026, though specific dates for these milestones are not provided in the content.
The Data Monitoring Committee oversees the Phase 3 FLASH2 trial and is responsible for monitoring safety data, with their recent conclusion that there are no safety issues with the ongoing trial.
There is mounting interest in HyBryte™ because it represents a novel skin-directed therapy for CTCL, a rare disease with substantial unmet medical need.
The latest news and updates relating to SNGX are available in the company's newsroom at https://ibn.fm/SNGX.
Soligenix is a biopharmaceutical company focused on rare diseases and treatments with substantial unmet medical need, with HyBryte™ being their lead therapy for CTCL.
Reaching this safety milestone means one major hurdle is cleared, allowing the company to focus more explicitly on efficacy and regulatory strategy for their CTCL program.
Curated from InvestorBrandNetwork (IBN)
