Soligenix (NASDAQ: SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The company today announced interim results from the ongoing open-label, investigator-initiated study (“IIS”) evaluating extended HyBryte(TM) (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage cutaneous T-cell lymphoma (“CTCL”).
“We are pleased with these recent study results, giving patients an opportunity to access the therapy in an open-label setting,” said Soligenix CEO and President Christopher J. Schaber. “CTCL is an incredibly difficult to treat orphan disease and remains an area of unmet medical need with a very limited number of safe and effective therapies. Following the initial Phase 3 FLASH study, which demonstrated the safety and efficacy of shorter courses of HyBryte(TM) therapy, we are pleased to see that continuing treatment for longer time periods is resulting in the anticipated improved outcomes for patients. The majority of patients show a strong treatment response by week 18, a noticeable advantage over other therapies that may take six to 12 months to show improvement. As the body of compelling data continues to grow in support of this novel therapy, we look forward to continuing to work with Dr. Kim on this important study as well as advancing enrollment in the 80-patient confirmatory Phase 3 FLASH 2 replication study. We will plan to provide additional updates on the IIS as data becomes available.”
To view the full press release, visit https://ibn.fm/rgLBj
About Soligenix Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) (“SGX301” or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide.
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