- The FDA designates Soligenix's (NASDAQ:SNGX +1.4%) investigational SGX943 (dusquetide) for Fast Track review for the treatment melioidosis, a potentially fatal infection caused by the Gram-negative bacterium Burkholderia pseudomallei, which is highly resistant to many antibiotics. It is a major public health issue in Southeast Asia and Northern Australia. The mortality rate can be as high as 40%.
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Dusquetide is a member of a class of peptides called an innate defense regulator (IDR) which has no direct antibiotic activity but modulates host responses, increasing survival and accelerating the resolution of tissue damage following exposure to pathogens.
- Fast Track status allows for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).