The Data Monitoring Committee overseeing Soligenix Inc.'s confirmatory Phase 3 FLASH2 trial of HyBryte™ has reported no safety concerns to date, affirming the therapy's safety profile for treating early-stage cutaneous T-cell lymphoma. 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, a biopharmaceutical company focused on rare diseases and treatments with substantial unmet need, is developing HyBryte (synthetic hypericin) for early-stage CTCL and is now advancing toward critical milestones in 2026. The company announced that the DMC concluded there are no safety issues with the ongoing Phase 3 trial (https://ibn.fm/NGMxi).
The FLASH2 study builds on the earlier Phase 3 FLASH trial and will enroll approximately 80 subjects with early-stage CTCL, patch or plaque phase disease. 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.
Soligenix's announcement arrives amid mounting interest in HyBryte as a novel skin-directed therapy. The latest news and updates relating to SNGX are available in the company's newsroom at https://ibn.fm/SNGX. This development underscores the advancing clinical trajectory of Soligenix's lead therapy and represents progress for patients with limited treatment options for this rare form of lymphoma.
