Soligenix has announced encouraging interim results from an open-label, investigator-initiated study evaluating HyBryte, a synthetic hypericin treatment for early-stage cutaneous T-cell lymphoma (CTCL). The study examined extended treatment periods of up to 54 weeks, revealing significant potential for addressing this rare and difficult-to-treat disease.
The research provides critical insights into the long-term efficacy of HyBryte, with most patients showing a strong treatment response by week 18. This timeframe represents a notable advantage over existing therapies, which can take six to 12 months to demonstrate improvement.
CTCL remains an orphan disease with limited therapeutic options, making this research particularly significant. The study builds upon previous Phase 3 FLASH study results, which initially demonstrated the therapy's safety and effectiveness.
Soligenix CEO Christopher J. Schaber emphasized the importance of these findings, highlighting the potential for providing patients with a more effective treatment approach. The company plans to continue the investigator-initiated study and advance enrollment in a confirmatory 80-patient Phase 3 FLASH 2 replication study.
The ongoing research represents a critical step toward potentially developing a novel photodynamic therapy that could offer new hope for patients with this challenging lymphoma subtype.
