Soligenix Inc. (NASDAQ:SNGX) jumped 16% in premarket trading on Tuesday after announcing that an independent Data Monitoring Committee (DMC) had found no safety concerns in the ongoing Phase 3 FLASH2 clinical trial evaluating HyBryte for cutaneous T-cell lymphoma (CTCL).
The committee determined that HyBryte (synthetic hypericin) continues to demonstrate an acceptable safety profile, consistent with earlier clinical results. The finding represents a key milestone for Soligenix as it advances the confirmatory Phase 3 study, which follows a previously successful trial of the same therapy.
“We are pleased to have reached this important milestone, confirming the expected safety to date in the confirmatory FLASH2 study,” said Christopher J. Schaber, President and CEO of Soligenix. The company plans to release an enrollment update in the fourth quarter of 2025 and conduct a blinded interim efficacy analysis in the first half of 2026.
The FLASH2 study aims to enroll about 80 patients with early-stage CTCL in a randomized, double-blind, placebo-controlled design. Unlike the original Phase 3 trial, FLASH2 extends the treatment duration to 18 continuous weeks without breaks between cycles.
HyBryte is a novel photodynamic therapy that utilizes visible light to activate synthetic hypericin applied topically to skin lesions. The treatment has been granted Orphan Drug and Fast Track designations by the U.S. FDA, as well as Orphan Designation by the European Medicines Agency (EMA).
In the earlier Phase 3 FLASH trial, 49% of patients treated with HyBryte over three cycles showed a positive clinical response. The therapy is viewed as a potentially safer alternative to existing CTCL treatments, which often pose risks such as melanoma or extensive skin damage.
Soligenix said it expects to report topline results from the FLASH2 trial in the second half of 2026.
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