Soligenix Achieves Enrollment Milestone in Phase 3 CTCL Therapy Trial

Soligenix Inc. (NASDAQ: SNGX) has completed the planned enrollment of 50 patients necessary for the interim analysis in its 80-patient confirmatory Phase 3 clinical trial evaluating HyBryte(TM) (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (https://ibn.fm/ZeQoN). This enrollment milestone represents a crucial step forward for the FLASH2 study, which builds upon the previous statistically significant Phase 3 FLASH study. The promising early results are further corroborated by an ongoing investigator-initiated study being conducted at the University of Pennsylvania. Soligenix is positioning itself to potentially deliver the first FDA-approved photodynamic therapy specifically indicated for CTCL.

The FLASH2 study is a randomized, double-blind, placebo-controlled clinical trial that represents a pivotal advancement for patients suffering from this rare form of skin cancer. The achievement of this enrollment target brings the investigational treatment significantly closer to potential FDA approval. The company's progress is particularly noteworthy given the specialized nature of this treatment and the patient population it serves. Cutaneous T-cell lymphoma represents a significant unmet medical need, and the development of targeted therapies has been limited despite the condition's impact on patients' quality of life.

The interim analysis will provide critical data on the treatment's efficacy and safety profile as the trial progresses toward its full enrollment target of 80 patients. This milestone demonstrates the company's ability to execute its clinical development strategy and maintain momentum in bringing this potential therapy to market. The successful enrollment also reflects patient and investigator confidence in the treatment approach, which is essential for rare disease trials where patient recruitment can be challenging. The blinded response rate data collected during this phase will inform the trial's continuation and eventual submission to regulatory authorities.

Soligenix's progress with HyBryte represents an important development in the field of dermatological oncology, where treatment options for CTCL have remained limited. The photodynamic therapy approach offers a potentially targeted mechanism of action that could provide benefits over existing treatments. As the trial moves forward, the data collected will be crucial for determining the treatment's place in the therapeutic landscape and its potential impact on patient care. The company's achievement of this enrollment milestone positions it to potentially address a significant gap in available treatments for this challenging condition.