- This milestone is significant because regulatory pathways for orphan diseases such as CTCL often hinge not only on efficacy, but on establishing a favorable safety profile.
- Soligenix’s announcement arrives amid mounting interest in HyBryte[TM] as a novel skin-directed therapy.
- For biotechnology companies working in rare diseases, reaching a safety milestone means one major hurdle is cleared and focus can shift more explicitly to efficacy and regulatory strategy.
In a key development that underscores the advancing clinical trajectory of its lead therapy, Soligenix (NASDAQ: SNGX) announced that the Data Monitoring Committee (“DMC”) overseeing its confirmatory Phase 3 FLASH2 trial of HyBryte(TM) has reported no safety concerns to date, affirming the therapy’s safety profile. Soligenix, a biopharmaceutical company focused on rare diseases and treatments with substantial unmet need, is developing HyBryte (synthetic hypericin) for early-stage cutaneous T-cell lymphoma (“CTCL”) and is now advancing toward critical milestones in 2026.
According to the company, the DMC concluded that there are no safety issues with the ongoing Phase 3 trial (https://ibn.fm/NGMxi). The study, named FLASH2, builds on the earlier Phase 3 FLASH trial and will enroll approximately 80 subjects with early-stage CTCL, patch or plaque phase disease…
NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX
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