SNGX - SNGX: Agreement with EMA on Second Confirmatory Trial for HyBryte™ | Benzinga
Business Update
Reaches Agreement with European Medicines Agency on Second Confirmatory Trial for HyBryte™
On April 3, 2024, Soligenix, Inc. (NASDAQ: SNGX) announced it has reached agreement with the European Medicines Agency (EMA) on the key design elements for a confirmatory Phase 3 trial of 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 that will enroll approximately 80 subjects with CTCL. HyBryte will be applied topically to CTCL lesions twice weekly for 18 weeks, with each application followed 21 (± 3) hours later by the administration of visible light at a wavelength of 500 to 650 nm. The light will be administered starting at 6 J/cm2 and will be increased upwards by 2 J/cm2 until: 1) the patient experiences a Grade 1 erythema; 2) the patient reaches a maximum dose of 30 J/cm2, or 3) the patient cannot tolerate the treatment time, whichever comes first. All of the subject's lesions that are readily available to the visible light source will be treated and 3 to 5 index lesions will be prospectively identified and indexed for the modified composite assessment of index lesions ...