Healthcare Industry News:  SJIA 

Biopharmaceuticals FDA

 News Release - August 18, 2016

FDA Grants Soligenix Orphan Drug Designation for Dusquetide for Treatment of Macrophage Activation Syndrome

PRINCETON, N.J., Aug. 18, 2016 -- (Healthcare Sales & Marketing Network) -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the US Food and Drug Administration (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 US 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, PhD, 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."

About Macrophage Activation Syndrome

Macrophage activation syndrome (MAS) is characterized by a highly stimulated but ineffective immune response; however, its pathogenesis is poorly understood. MAS has many similarities with that of the other forms of hemophagocytic lymphohistiocytosis. MAS is a life-threatening complication of rheumatic disease that, for unknown reasons, occurs much more frequently in individuals with systemic juvenile idiopathic arthritis (SJIA). Besides SJIA, systemic lupus erythematosus (SLE), and Kawasaki disease are two other rheumatologic conditions in which MAS appears to occur somewhat more frequently than in other diseases. In adults, based on limited epidemiologic studies, MAS is seen most frequently in association with adult onset Still's disease, SLE, and various vasculitic syndromes. MAS is characterized by pancytopenia, liver insufficiency, coagulopathy and neurologic symptoms and is thought to be caused by the activation and uncontrolled proliferation of T lymphocytes and well-differentiated macrophages, leading to widespread hemophagocytosis and cytokine overproduction. Despite treatment, fatalities still occur with a mortality rate in the range of 10-20%.

About Dusquetide

Dusquetide is an innate defense regulator (IDR), a new class of short, synthetic peptide. It has a novel mechanism of action in that it modulates the body's reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, melioidosis, MAS and other bacterial infections. In a published mouse model of MAS, dusquetide was shown to reduce the pancytopenia, reduced IL-12 responses and improve body weight maintenance.

Source: Soligenix

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