Soligenix (NASDAQ: SNGX) : Revolutionizes Rare Disease Treatment & Advances Groundbreaking Vaccines
Jan. 24, 2024
Soligenix is a late-stage biopharmaceutical company specializing in developing and commercializing products to treat rare diseases with unmet medical needs. The Company's primary focus is on its Specialized BioTherapeutics business segment, which is responsible for the development of HyBryte™, a novel photodynamic therapy that uses safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). The Company has successfully completed a Phase 3 study for HyBryte™ and is now negotiating a confirmatory Phase 3 pivotal study design with the US Food & Drug Administration, while also evaluating/pursuing potential HyBryte™ marketing approval ex-U.S. with the successfully completed Phase 3 study.
Additionally, Soligenix is expanding synthetic hypericin (SGX302) into psoriasis, as well as developing proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention and treatment of gastrointestinal (GI) disorders characterized by severe inflammation. The Company is also developing a first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942), to treat inflammatory diseases, including oral mucositis in head and neck cancer. Soligenix received FDA IND clearance in Q4 2023 for a Phase 2 trial of dusquetide for the treatment of aphthous ulcers of Behçet's disease.
Soligenix's Public Health Solutions business segment is responsible for the development of a number of exciting new products designed to combat a variety of severe medical conditions, including RiVax®, a ricin toxin vaccine candidate that will combat ricin poisoning, and SGX943, a therapeutic candidate designed to combat antibiotic-resistant and emerging infectious diseases. The Company is also working on a number of vaccine programs focused on filoviruses, including Ebola and Marburg, as well as a promising vaccine candidate for the prevention of COVID-19. Soligenix is utilizing a proprietary heat stabilization platform called ThermoVax® to develop its vaccine products. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA).
