Soligenix Inc. (SNGX) has shared encouraging interim data from a study on HyBryte(TM), a synthetic hypericin treatment for early-stage cutaneous T-cell lymphoma (CTCL), in a recent podcast by the Cutaneous Lymphoma Foundation. Dr. Ellen Kim, the study's Principal Investigator, reported a 75% treatment success rate at 18 weeks, with improvements reaching up to 85% in patients treated through 54 weeks. This study, mirroring the design of the ongoing FLASH2 confirmatory trial, builds on previous Phase 3 FLASH trial results and is noted for its real-world clinical practice approach, eliminating rest periods and extending treatment duration to enhance efficacy.
Dr. Kim highlighted HyBryte's safety and tolerability, with no serious side effects reported and only one dropout due to logistical reasons. The treatment's non-mutagenic mechanism and rapid response time position it as a potentially safer and more effective alternative to traditional CTCL treatments like steroids, chemotherapy, and phototherapy. This development is particularly significant for patients with early-stage CTCL, a chronic and underserved cancer, offering new hope where current skin-directed therapies fall short.
The progress of HyBryte underscores the urgent need for innovative treatments in the CTCL space, with Soligenix Inc. moving closer to potential commercialization following successful Phase 3 study completions. The company's focus on rare diseases with unmet medical needs is evident in its pipeline, which includes treatments for psoriasis, inflammatory diseases, and vaccine candidates for ricin toxin, filoviruses, and COVID-19, supported by government grants and contracts.
