FDA grants Soligenix’s Dusquetide Orphan designation for Macrophage Activation Syndrome
Soligenix, a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, has announced that the Office of Orphan Products Development of the FDA has granted Orphan drug designation to the active ingredient dusquetide for treatment of macrophage activation syndrome (MAS). Dusquetide has previously received Orphan drug designation for the treatment of acute radiation syndrome (ARS).
Dusquetide is an innate defense regulator (IDR), a new class of short, synthetic peptides that accelerates bacterial clearance and resolution of tissue damage while modulating inflammation following exposure to a variety of agents including bacterial pathogens, trauma, radiation and/or chemotherapy.
The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to providing a seven year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application, and certain tax credits.
"The FDA's decision to grant dusquetide orphan drug designation signifies an important step for Soligenix as we continue to expand our biotherapeutics pipeline and the many potential applications of our novel IDR technology," stated Christopher J. Schaber, Ph.D., president and chief executive officer of Soligenix. "Dusquetide's activity in preclinical models has demonstrated the potential to enhance mechanisms of the innate immune system to clear infection and modulate the inflammatory response, the critical attributes of this syndrome. The marketing exclusivity that orphan drug designation imparts adds significantly to the existing intellectual property surrounding dusquetide."