Soligenix Completes Enrollment for Interim Analysis in HyBryte Phase 3 Trial for Cutaneous T-Cell Lymphoma

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. This development matters because it represents tangible progress toward addressing a difficult-to-treat cancer with few effective therapies. The potential approval of HyBryte would not only provide a new treatment option but also validate photodynamic therapy as a viable approach for this specific malignancy. The accelerated timeline resulting from this enrollment completion could mean earlier access for patients if the treatment proves successful in the confirmatory trial.

The implications extend beyond patient care to the broader pharmaceutical landscape, where successful development of therapies for rare diseases can demonstrate the viability of specialized treatment approaches. The company's progress through this critical phase of clinical testing suggests that the scientific foundation established in earlier studies remains robust. The collaboration with academic institutions like the University of Pennsylvania adds credibility to the research approach and may facilitate broader acceptance within the medical community. As the data analysis proceeds, the medical community will be watching closely to see if this potential therapy can fulfill its promise for a patient population with limited alternatives. The interim results will provide crucial information about whether the treatment effect observed in earlier studies can be replicated in this larger confirmatory trial, which is essential for regulatory approval and eventual clinical implementation.