- Soligenix (SNGX, Financial) advances HyBryte™ for treating cutaneous T-cell lymphoma (CTCL), showing promising clinical results in Phase 3 trials.
- HyBryte™ presents unique advantages: it is non-mutagenic, avoids DNA damage, and has no systemic absorption.
- There has been no new FDA-approved skin-directed therapy for CTCL in over a decade, highlighting the importance of HyBryte™'s potential.
Soligenix, Inc. (SNGX), a biopharmaceutical company, has highlighted the promising development of HyBryte™ (synthetic hypericin) for cutaneous T-cell lymphoma (CTCL), specifically targeting mycosis fungoides, the most common form of CTCL. This follows insights shared by Dr. Ellen Kim, Lead Principal Investigator for the ongoing Phase 3 FLASH studies, in a recent Q&A session.
Dr. Kim emphasized the novel aspects of HyBryte™, pointing out its non-mutagenic properties, which theoretically reduce the risk of skin cancer compared to conventional phototherapy that damages DNA. Importantly, HyBryte™ demonstrates no systemic absorption, bolstering its safety profile, as evidenced by clinical trials where no serious adverse events led to participant dropouts.
This development addresses a substantial unmet need, as there has been no new FDA-approved skin-directed therapy for CTCL in over 10 years. Current CTCL treatments can pose risks such as contact dermatitis and potential skin cancer from long-term phototherapy. HyBryte™ aims to mitigate these risks, offering a safer, well-tolerated alternative.
With open enrollment for Phase 3 trials underway, Dr. Kim expressed optimism about the potential impact of HyBryte™ in early-stage CTCL treatment. Continued research and trials could lead to regulatory approval and commercialization, providing a critical new option for CTCL patients.
