DMC recommends halting Ph 3 FLASH2 trial of HyBryt (Synthetic Hypericin) in the treatment of CTCL patients post interim efficacy analysis
“We are obviously very disappointed with the unanticipated outcome of the study,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “Despite the fact that HyBryte™ demonstrated statistically significant reductions in CTCL lesions after 6 weeks treatment in the first FLASH study, a similar signal was not observed with 18 weeks of treatment in this study. Over the coming weeks, we will analyze the data to better determine why the study did not meet expectations. If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from HyBryte™ therapy, then we intend to communicate our findings and explore follow-up discussions with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).”
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