Soligenix Initiates Late-Stage Trial for HyBryte in Blood Cancer Treatment

Soligenix, Inc., a late-stage biopharmaceutical company, has kicked off a confirmatory late-stage trial for its novel photodynamic therapy, HyBryte™, in the treatment of cutaneous T-cell lymphoma (CTCL), a type of blood cancer. This move comes on the heels of positive clinical results from a compatibility study, which demonstrated HyBryte™'s efficacy and safety in treating CTCL patients.

HyBryte™, a first-in-class photodynamic therapy, utilizes safe, visible light for activation. The active ingredient, synthetic hypericin, is topically applied to skin lesions and taken up by malignant T-cells. Upon activation by visible light approximately 24 hours later, hypericin exhibits significant anti-proliferative effects on activated normal human lymphoid cells and inhibits the growth of malignant T-cells isolated from CTCL patients.

In the recent compatibility study, HyBryte™ demonstrated a 22% treatment response rate after 8 weeks of twice-weekly therapy. Seven of 27 index lesions showed at least a 50% improvement in their Composite Assessment of Index Lesion Severity (CAILS) score, with four lesions completely resolved. These results are consistent with the Phase 3 FLASH study, indicating that HyBryte™ is a viable treatment option for CTCL patients.

The safety profile of HyBryte™ is also notable. The study yielded extremely low and limited levels of systemic hypericin detected in the blood and no observable impact to normal sinus rhythm. This suggests that HyBryte™ may be a safer alternative to existing treatments, which often rely on DNA-damaging drugs and ultraviolet exposure.

The confirmatory late-stage trial addresses previous study limitations by expanding the patient population to include those with more extensive disease, replicating results using finished drug product manufactured by the proposed commercial contract manufacturer, and activating the drug using a commercially viable light device. This design ensures the results are more representative of real-world use and supports the potential commercialization of HyBryte™.

The primary endpoint of the trial is the number of treatment successes, defined as ≥50% reduction in the cumulative mCAILS score from Baseline to end of the treatment. This is consistent with the Phase 3 FLASH study. However, the current study allows for potential transition to a "real-world" setting with home-use, which was not an option in the FLASH study. Additionally, the study evaluates systemic exposure and cardiac output, providing a more comprehensive understanding of HyBryte™'s safety and efficacy in a real-world setting.



The potential market size for HyBryte in the CTCL treatment landscape is significant. According to Future Market Insights, the global blood cancer treatment market was valued at US$ 10.5 billion in 2020 and is expected to grow at a CAGR of 7.5% from 2021 to 2031, reaching US$ 21.5 billion by 2031. Within this market, CTCL represents a substantial segment, with an estimated prevalence of around 20,000 to 50,000 cases in the United States alone. Assuming a conservative market share of 10% for HyBryte in the CTCL segment, the potential market size for HyBryte could be around US$ 2.15 billion by 2031, with a growth rate of approximately 7.5% CAGR.

In conclusion, Soligenix's initiation of the confirmatory late-stage trial for HyBryte™ in the treatment of CTCL is a significant step towards addressing the unmet medical need in this orphan patient population. With promising efficacy and safety data, HyBryte™ has the potential to become a valuable addition to the CTCL treatment landscape. As the trial progresses, investors should closely monitor the results and consider the potential market size and growth rate for HyBryte™ in the CTCL treatment market.