Soligenix Inc. has completed enrollment for the interim analysis in its confirmatory Phase 3 clinical trial evaluating HyBryte for cutaneous T-cell lymphoma, marking a significant step toward potential FDA approval for what could become the first photodynamic therapy specifically indicated for this rare skin cancer. The company announced it has enrolled the planned 50 patients needed for this analysis within its 80-patient FLASH2 study, which builds upon previous positive Phase 3 results.
The FLASH2 trial is a randomized, double-blind, placebo-controlled study designed to confirm the efficacy and safety of HyBryte, also known as synthetic hypericin. This milestone is particularly significant because early blinded response rates have been encouraging, suggesting the treatment continues to show promise. These results are further supported by an ongoing investigator-initiated study at the University of Pennsylvania, which provides additional validation of the treatment approach.
Cutaneous T-cell lymphoma represents an area of significant unmet medical need, with limited treatment options available for patients. The successful completion of this enrollment milestone accelerates the timeline for potential regulatory submission and brings hope to patients suffering from this challenging condition. The previous FLASH study demonstrated statistical significance, providing a strong foundation for the current confirmatory trial.
For investors and stakeholders following the company's progress, the latest developments are available through the company's newsroom at https://ibn.fm/SNGX. The biomedical communications platform BioMedWire, which distributed this announcement, provides specialized coverage of biotechnology and life sciences sectors through its network, though the company emphasizes that readers should review full disclaimers at https://www.BioMedWire.com/Disclaimer. The interim analysis data, once unblinded and analyzed, will determine whether the trial continues as planned toward full enrollment and eventual regulatory submission.
