FDA Grants Soligenix Fast Track Designation for SGX943 for the Treatment of Melioidosis

FDA Updates

Princeton, NJ-based Soligenix, Inc. announced that its SGX943 (dusquetide) development program has received Fast Track designation from the US FDA as adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis, a serious and potentially life-threatening condition.  Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition.

Melioidosis is a potentially fatal infection caused by the Gram-negative bacillus, Burkholderia pseudomallei (Bps).  Highly resistant to many antibiotics, Bps can cause an acute disease characterized by a fulminant pneumonia and a chronic condition that can recrudesce.  There is no preventive vaccine or effective immunotherapy for melioidosis.  Bps infection (melioidosis) is a major public health concern in the endemic regions of Southeast Asia and Northern Australia.  Moreover, the organism has a worldwide distribution and the full extent of global spread is likely underestimated.  Bps activity is seen in Southeast Asia, South America, Africa, the Middle East, India, and Northern Australia.  The highest pockets of disease activity occur in Northern Australia and Northeast Thailand, Burma and Vietnam, and is likely under-reported in China.  In Northeast Thailand, the mortality rate associated with Bps infection is over 40%, making it the third most common cause of death from infectious disease in that region after HIV/AIDS and tuberculosis.




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