- The original FLASH study enrolled 169 patients across three treatment cycles.
- The ongoing FLASH 2 trial builds on findings found in the first study while addressing regulatory requirements for confirmatory evidence.
- For Soligenix, the FLASH studies represent more than clinical milestones. These studies are key steps in the company’s regulatory and commercial journey.
Soligenix (NASDAQ: SNGX) is continuing to build momentum in its mission to advance HyBryte(TM), a first-in-class treatment for early-stage cutaneous T-cell lymphoma (“CTCL”). That progress is supported by results from its pivotal FLASH trial and its ongoing FLASH 2 confirmatory study. Together, the studies highlight not only the efficacy of synthetic hypericin activated by safe fluorescent light but also the company’s broader strategy to establish HyBryte as a new standard of care in a field where therapeutic innovation has lagged (https://www.ibn.fm/G18Hp). With statistically significant data already achieved and confirmatory enrollment well underway, Soligenix is taking important steps toward potential regulatory approvals Worldwide.
The original FLASH study, the largest double-blind, randomized, placebo-controlled trial ever conducted in CTCL, enrolled 169 patients across three treatment cycles. Patients receiving HyBryte showed compelling results, with statistically significant improvements observed as early as six weeks.
After 12 weeks, 40% of patients achieved meaningful responses, which increased to 49% at 18 weeks. Importantly, these benefits extended to both patch and plaque lesions, an area where existing therapies often fall short. Safety was also a distinguishing factor, with HyBryte demonstrating a strong tolerability profile, especially when compared to phototherapies reliant on carcinogenic ultraviolet light.
The ongoing FLASH 2 trial builds directly on these findings while addressing regulatory requirements for confirmatory evidence. Unlike the original study, which featured a blinded six-week treatment cycle followed by two open-label six-week extensions (total 18 weeks), FLASH 2 has been designed as a double-blind, placebo-controlled study with 18 weeks of continuous treatment.
Approximately 80 patients are being enrolled across the United States, and the trial structure reflects insights gained from the earlier study, including optimizing light dosing schedules and ensuring consistent lesion monitoring. This approach is expected to yield an even greater magnitude of response, with Soligenix projecting a higher probability of clinical and regulatory success given the durability of benefits demonstrated in the first trial.
In parallel, an investigator-initiated study (“IIS”) at the University of Pennsylvania is extending the evaluation of HyBryte’s efficacy with long-term continuous dosing (https://ibn.fm/P3UBg). Early interim results have been particularly encouraging, showing a 75% response rate at week 18 in a small cohort of patients. This data complements the company’s phase 3 trials by demonstrating how HyBryte performs under real-world clinical conditions, reinforcing its potential as a practical and durable therapy.
The implications of these results are significant. CTCL is a rare, chronic and incurable form of non-Hodgkin’s lymphoma, with patients often enduring years of recurring symptoms and cycles of treatment. With no US Food and Drug Administration (“FDA”)-approved first-line therapies for early-stage disease, healthcare providers are left with limited options that are often associated with harsh side effects or limited efficacy. By delivering both efficacy and safety in a skin-directed therapy, HyBryte addresses a clear unmet need in early-stage CTCL, offering patients new treatment options while entering a market that Soligenix estimates may exceed $250 million annually worldwide for this indication.
For Soligenix, the FLASH studies represent more than clinical milestones. These studies are key steps in the company’s regulatory and commercial journey. Positive results from FLASH and encouraging early data from the IIS, along with positive results from the ongoing FLASH2 provide the foundation for marketing applications worldwide. Together, these efforts align with Soligenix’s strategy of targeting underserved markets with innovative, safe and effective therapies.
Looking ahead, the company anticipates that FLASH 2 enrollment will continue into 2026, setting the stage for top-line data readouts that could transform the treatment landscape for CTCL. Should results mirror or exceed the first FLASH trial, HyBryte could become the first approved front-line therapy for early-stage CTCL, reshaping standards of care and strengthening Soligenix’s position as a leader in rare dermatologic oncology.
For more information, visit www.Soligenix.com.
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