Soligenix gets FDA meeting to discuss phase 3 trial design of photodynamic therapy HyBryte
Iryna Drozd
- Soligenix (NASDAQ:SNGX) said the U.S. Food and Drug Administration (FDA) has granted a Type A meeting to discuss the design of a second phase 3 trial of photodynamic therapy HyBryte ointment to treat cutaneous T-cell lymphoma (CTCL)
- The company expects update on the meeting outcome in June.
- "Responding to FDA feedback, Soligenix has submitted a confirmatory Phase 3 draft study protocol retaining the key aspects of the first Phase 3 trial," said President and CEO Christopher Schaber.
- Earlier in May, the company reported data from a compatibility study of HyBryte. Soligenix had said that besides meeting the goals, the efficacy shown substantiated results of a phase 3 trial called FLASH.
- HyBryte (SGX301) is a photodynamic therapy which uses visible light in the red-yellow spectrum for activation. The active ingredient in HyBryte is synthetic hypericin, a photosensitizer which is topically applied to skin lesions which is taken up by cancerous T-cells, and then activated by visible light about 24 hours later.
- SNGX +1.67% to $0.83 premarket May 11