Soligenix CTCL Therapy Clears Safety Review in Phase 3 Trial

Soligenix Inc. has strengthened its cutaneous T-cell lymphoma program as the Data Monitoring Committee overseeing its confirmatory Phase 3 FLASH2 trial of HyBryte has reported no safety concerns to date, affirming the therapy's safety profile. 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. The company, which focuses on rare diseases and treatments with substantial unmet need, is developing HyBryte for early-stage 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. 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 an important step forward for patients suffering from this rare form of lymphoma. The positive safety review provides confidence in the therapy's profile as it progresses through clinical development, potentially offering a new treatment option for a condition with limited therapeutic alternatives.