## Soligenix Announces Agreement with EMA on Phase 3 Trial for HyBryte™
Soligenix, Inc. (SNGX) announced on April 3, 2024, that it has reached an agreement with the European Medicines Agency (EMA) on the design of a confirmatory Phase 3 trial for HyBryte™ (synthetic hypericin) for the treatment of cutaneous T cell lymphoma (CTCL).
The proposed Phase 3 FLASH 2 trial will be a randomized, double-blind, placebo-controlled, multicenter study enrolling approximately 80 subjects with CTCL. HyBryte will be applied topically to CTCL lesions twice weekly for 18 weeks, followed by visible light administration at a specific wavelength. The primary endpoint will be the percentage of patients in each treatment group achieving a partial or complete response of the treated lesions. The trial is expected to begin enrollment before the end of 2024, with topline results anticipated in the second half of 2026.
Soligenix is also in discussions with the U.S. Food and Drug Administration (FDA) on an appropriate study design for HyBryte, as the agency prefers a longer duration comparative study over a placebo-controlled trial.
## SuVax™ Granted Orphan Drug Designation by FDA
On April 11, 2024, Soligenix announced that the U.S. FDA has granted orphan drug designation (ODD) to the active ingredient in SuVax™, the subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein, for the prevention and post-exposure prophylaxis against SUDV infection.
ODD is designed to assist companies developing therapies for rare diseases and disorders, defined as those affecting 200,000 people or fewer in the U.S. Drugs granted ODD receive a seven-year term of market exclusivity upon final FDA approval, along with financial and regulatory benefits.
SuVax addresses the potentially lethal Sudan Virus Disease caused by SUDV. While vaccines exist for Zaire ebolavirus, they are ineffective against SUDV. Previous results showed that SuVax offered 100% protection of non-human primates infected with a lethal dose of SUDV. SuVax is based on the company's novel vaccine platform, which includes a robust protein manufacturing process, a nano-emulsion adjuvant, and thermostabilization of the adjuvant and antigen in a single vial.
## Increased Valuation for Soligenix
With the protocol in place for the second Phase 3 study of HyBryte, Soligenix has increased its probability of approval, leading to an increased valuation of $4.00. The company's progress in developing both HyBryte and SuVax is promising, and we look forward to further updates on their clinical trials.