U.S. Food and Drug Administration Awards $2.6 Million Orphan Products Development Grant

U.S. FDA Approves Nova Mentis Orphan Drug Application

Soligenix, Inc. ( Nasdaq: SNGX), 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 U.S. Food and Drug Administration (FDA) has awarded an Orphan Products Development grant to support the evaluation of HyBryte™ (synthetic hypericin) for expanded treatment in patients with early-stage CTCL. The grant, totaling $2.6 million over 4 years, was awarded to a prestigious academic institution that was a leading enroller in the recently published positive Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in the treatment of early stage cutaneous T-cell lymphoma (CTCL).

“We are pleased the FDA is supporting the HyBryte™ program and giving patients an opportunity to access the therapy in an open-label setting,” stated Christopher J. Schaber, President and CEO of Soligenix, Inc. “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 treatment options. The Phase 3 results provide the basis for our upcoming marketing application and this study will serve to embark on potential home-use of the therapy, augment the safety database as well as provide further real-world evidence into the practical use of HyBryte™ once commercially available.”

The clinical study RW-HPN-MF-01, “Assessment of Treatment with Visible Light Activated Synthetic Hypericin Ointment in Mycosis Fungoides Patients” is designed as an open-label, multicenter clinical trial enrolling approximately 50 patients at up to six of the highest enrolling clinical centers that participated in the Phase 3 FLASH study. Patients have the potential to be treated for up to 12 months with twice a week dosing (visible light activation to follow ointment application by 24 ± 6 hours). The primary endpoint for the study will be evaluating the number of treatment successes defined as ≥50% reduction in the cumulative CAILS (Composite Assessment of Index Lesion Severity) score from baseline to end of the treatment. Study initiation is planned for the fourth quarter of 2022.