Soligenix Reaches Major Safety Milestone for HyBryte™ in Treating Cutaneous T-Cell Lymphoma

Soligenix Achieves a Milestone in HyBryte™ Development for CTCL

In a significant development for the treatment of cutaneous T-cell lymphoma (CTCL), Soligenix, Inc. (Nasdaq: SNGX) has announced that its confirmatory Phase 3 clinical trial of HyBryte™ (synthetic hypericin) has reached an essential safety milestone. The Data Monitoring Committee (DMC) reviewed the study and found no safety concerns thus far, further validating the positive safety profile of the treatment that was observed in prior clinical studies.

HyBryte™ is a groundbreaking photodynamic therapy that employs visible light to activate synthetic hypericin, a potent photosensitizer that targets malignant T-cells in the skin. The current Phase 3 study, named FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2), builds upon the success of the previous FLASH study, which demonstrated statistically significant efficacy in early-stage CTCL patients. The FLASH2 trial aims to confirm and expand upon these findings in a real-world clinical setting, and is designed to enroll approximately 80 patients with early-stage CTCL.

Dr. Christopher J. Schaber, President and CEO of Soligenix, expressed his satisfaction with reaching this milestone, emphasizing that the safety confirmation is vital as patient enrollment continues to progress smoothly. Soligenix is currently on track to provide an update regarding enrollment status by the end of 2025 and is preparing for a blinded interim efficacy analysis in the first half of 2026.

Ellen Kim, MD, and the Lead Investigator for FLASH2, acknowledged the pressing need for effective treatments for CTCL, noting the potential of HyBryte™ to serve as a new therapeutic option. Patients suffering from this condition often face limited treatment choices, especially in its early stages, which makes the promising safety and efficacy profile of HyBryte™ particularly appealing. The treatment is expected to deliver rapid response rates while minimizing side effects, an important aspect highlighted by patients in previous studies.

The FLASH2 Study Design

The FLASH2 study closely mirrors the successful design of the initial FLASH trial but extends the treatment duration to 18 weeks without inter-cycle breaks. The previous study comprised three six-week treatment cycles, with a 49% response rate observed among participants receiving HyBryte™ compared to a placebo.

The extended treatment period in FLASH2 aims to capture the therapy's impact over a longer duration, which could greatly benefit patients by alleviating their symptoms without the severe side effects associated with other treatment options currently available.

HyBryte™ has garnered attention due to its mechanism that is not associated with DNA damage, making it a safer alternative compared to many existing therapies that carry significant risks, including the potential for secondary malignancies. This is particularly relevant in the context of treatment for CTCL, which can often be challenging given the limited options currently available and the serious nature of potential side effects from conventional treatments.

Looking Ahead

The ongoing FLASH2 trial is anticipated to deliver critical insights into the effectiveness of HyBryte™, with Soligenix poised to capitalize on the promising results from previous studies and with strong engagement from the CTCL community.

As the company proceeds with this study, it remains in active discussions with regulatory agencies to align on the best pathway for securing marketing approvals. Meanwhile, the encouraging feedback from earlier trials and the safety milestones achieved thus far set a solid foundation for the future of HyBryte™ in broader clinical practice.

In conclusion, Soligenix's progress with HyBryte™ offers hope to many patients affected by CTCL, with the potential for an efficacious treatment option that prioritizes safety and tolerability. As the clinical journey continues, stakeholders eagerly await further developments that could reshape the landscape for treating this rare yet impactful form of lymphoma.