FAQ: Soligenix's HyBryte™ Phase 3 FLASH2 Study Safety Review and CTCL Treatment Development
Summary
Soligenix announced that its Data Monitoring Committee completed the first safety review of the Phase 3 FLASH2 study for HyBryte™ in cutaneous T-cell lymphoma, finding no safety concerns and maintaining an acceptable safety profile consistent with prior trials.
What is the main announcement from Soligenix regarding HyBryte?
Soligenix announced that its Data Monitoring Committee completed its first review of the confirmatory Phase 3 FLASH2 study of HyBryte™ in cutaneous T-cell lymphoma, concluding there are no safety concerns and that the therapy maintains an acceptable safety profile consistent with prior trials.
What is HyBryte and what condition does it treat?
HyBryte™ (synthetic hypericin) is a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL), a rare disease where there is an unmet medical need.
Why is this safety review significant for the FLASH2 study?
This safety review is significant because it confirms no safety concerns and maintains an acceptable safety profile, allowing the Phase 3 trial to continue progressing on schedule toward potential regulatory approval and commercialization.
What are the key upcoming milestones for the FLASH2 study?
Enrollment is progressing on schedule with an update expected in Q4 2025 and a blinded interim efficacy analysis planned for the first half of 2026.
How does this Phase 3 FLASH2 study relate to Soligenix’s previous research?
The FLASH2 trial builds on the Company’s earlier statistically significant Phase 3 results and additional supportive studies demonstrating HyBryte’s efficacy and tolerability as a potential first-line treatment option for early-stage CTCL.
What other development programs does Soligenix have beyond HyBryte for CTCL?
Soligenix is also developing synthetic hypericin (SGX302) for psoriasis, dusquetide (SGX942) for inflammatory diseases including oral mucositis, and (SGX945) in Behcet’s Disease, plus vaccine programs for ricin toxin, filoviruses, and COVID-19.
Where can investors find more information about Soligenix and updates?
The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX.
What is Soligenix’s business focus and structure?
Soligenix is a late-stage biopharmaceutical company with two business segments: Specialized BioTherapeutics developing treatments for rare diseases, and Public Health Solutions developing vaccines supported by government funding from NIAID, DTRA, and BARDA.
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