Soligenix: FDA seeks additional study on lymphoma med

 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Company convened a Type A Meeting with the United States (U.S.) Food and Drug Administration (FDA). During the Type A Meeting, representatives of the Company and the FDA discussed the contents of a refusal to file (RTF) letter previously issued by the FDA regarding the Company's new drug application (NDA) for HyBryte™ (synthetic hypericin sodium) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer, where it successfully demonstrated statistically significant results in a Phase 3 clinical trial (Study HPN-CTCL-01; also referred to as the FLASH study).

In order to accept an NDA filing for HyBryte™, the FDA is requiring positive results from a second clinical study in addition to the Phase 3, randomized, double-blind, placebo-controlled FLASH study previously conducted in this orphan indication. The FDA indicated that it is open to engaging in protocol discussions regarding the second clinical study. Based on the feedback, the Company has decided to collaboratively engage in discussions with the FDA in order to define the protocol and evaluate the feasibility of conducting the additional clinical trial.

"While we are very disappointed by this delay, Soligenix and its clinical investigators remain committed to working with the FDA and advancing HyBryte™ to market for patients suffering with CTCL," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The Phase 3 FLASH study was the largest double-blind, randomized, placebo-controlled clinical trial ever conducted in the CTCL population. While we are surprised that the FDA did not accept our submitted NDA for filing and review, it was very clear that the FDA's thinking has evolved in evaluating CTCL therapies since our initial protocol discussions on Study HPN-CTCL-01 and that another Phase 3 study will be required to support an NDA for HyBryte™. During the Type A meeting, we discussed elements of protocol design for the additional confirmatory study and look forward to collaborating with the FDA to advance these discussions as quickly as possible to have a reasonable study design to meet the FDA's requirements."

https://finance.yahoo.com/news/soligenix-provides-regulatory-hybryte-113000542.html