HyBryte™ for the treatment of cutaneous T-cell lymphoma (CTCL)
HyBryte™ is a photodynamic topical therapy using a hypericin ointment activated by visible light which is intended for patients managing early stage CTCL disease progression. HyBryte™ has been granted both Orphan Drug and Fast Track designation in the US, Orphan Drug designation in Europe and Promising Innovative Medicine designation by the UK Health Authority.
A Phase 3 clinical study (FLASH – Fluorescent Light Activated Synthetic Hypericin) is complete. Stay tuned for more information about how this product is moving through the Soligenix pipeline towards approval. This study involved many of the key opinion leaders in CTCL.
SGX302 plaque psoriasis treatment for mild to moderate psoriasis
Using the same active ingredient as HyBryte™, SGX302 is a topical formulation with photosensitizing activity. Effective treatment of psoriasis lesions has been demonstrated in a Phase 1/2 proof of concept study, with a follow-on Phase 2 study planned to begin in H2 2022.
SGX942 for the treatment of oral mucositis (OM) in head and neck cancer patients receiving chemoradiation therapy
SGX942 contains the active ingredient dusquetide, a novel Innate Defense Regulator (IDR). IDRs modulate inflammation, enhance tissue healing and prevent and treat infection, all central issues in the development and progression of oral mucositis. SGX942 has been granted Fast Track designation in the US and Promising Innovative Medicine designation by the UK Health Authority.
SGX203 for the treatment of pediatric Crohn’s disease
SGX203 involves a proprietary oral formulation of the corticosteroid beclomethasone dipropionate (BDP) to provide comprehensive topical anti-inflammatory treatment of the gastrointestinal tract. SGX203 has been granted Orphan Drug and Fast Track designations in the US. We have negotiated a comprehensive Phase 3 trial with the FDA for conduct of the study. Study initiation is pending partnership/additional funding.