Broad efficacy and improved safety profile of HyBryte presented at Society for Investigative Dermatology Virtual Meeting.- Soligenix Inc.

Soligenix, Inc. announced that Ellen Kim, MD, Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine, Professor of Dermatology at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator for the Phase III FLASH (Fluorescent Light Activated Synthetic Hypericin) study, presented confirmatory data at the Society for Investigative Dermatology (SID) Virtual Meeting, held May 3-8, 2021. The presentation was selected to be shown during a Concurrent Mini-Symposium for Patient-Targeted Research. The presented data demonstrated the ability of HyBryte (SGX 301) to treat both patch and plaque disease, including generating complete disease responses, while being associated with fewer and less severe adverse events than other currently approved skin-directed therapies for cutaneous T-cell lymphoma (CTCL). Oral Presentation : Topical hypericin ointment photodynamic therapy is effective and safe in CTCL (FLASH study) Dr. Kim's presentation is archived on the SID Virtual Meeting site and will be accessible via registration until May 31, 2021. Key Highlights : i. HyBryte is activated by visible light at a wavelength of 500-650 nm, which provides deeper dermal penetration than ultraviolet (UV) spectrum light. This resulted in statistically significant clinical responses observed in patches as well as deeper plaque lesions, which are typically more difficult to treat and generally less responsive to UV light therapy. ii. In addition to its demonstrated, statistically significant efficacy which ultimately led to 49% of patients achieving at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) after 18 weeks of therapy (p<0.0001), complete responses of all treated index lesions were also shown to occur. these complete responses increased in frequency as treatment with hybryte continued and photographs demonstrating this response were reviewed. iii. compared to other, second-line, approved drugs for the treatment of ctcl, hybryte demonstrated significantly less safety concerns. this was reflected in the low rate of study discontinuation attributed to adverse events which showed only a 5% overall drop-out rate during the treatment phase in hybryte treated patients, lower than typically observed in other early stage ctcl trials. overall safety of hybryte is a critical attribute of this treatment and was monitored throughout the three treatment cycles (cycles 1, 2 and 3) and the 6-month follow-up period. hybryte's mechanism of action is not associated with dna damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects. predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. within this landscape, treatment of ctcl is strongly motivated by the safety risk of each product. hybryte potentially represents the safest available efficacious treatment for ctcl. with no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues. the phase iii ctcl clinical study was partially funded by the national cancer institute via a phase ii sbir grant (#1r44ca210848-01a1) awarded to soligenix, inc. soligenix, inc. announced that it has decided not to pursue a new drug application (nda) submission for sgx 301 until 1h 2022. the company previously guided that it would commence its submission this quarter. soligenix made the decision following discussions with the fda, while also citing delays in manufacturing, in part caused by the global covid-19 pandemic.>