FDA Grants Fast Track Designation for Melioidosis Treatment

There is currently no preventive vaccine or immunotherapy for melioidosis
There is currently no preventive vaccine or immunotherapy for melioidosis

Soligenix announced that the Food and Drug Administration (FDA) has granted Fast Track designation to SGX943 (dusquetide), a proposed adjunctive therapy for the treatment of melioidosis, a potentially fatal infection.

There is currently no preventive vaccine or immunotherapy for melioidosis, which is caused by Gram-negative bacillus, Burkholderia pseudomallei (Bps).

Dusquetide is an innate defense regulator (IDR), meaning it has no direct antibiotic activity but can modulate responses in the host. Dusquetide  has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity. 

Dusquetide has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers and preliminary efficacy and safety in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to chemoradiation therapy for head and neck cancer. At the moment there is no time-frame for the submission of any new drug applications for SGX943. 

The National Institute of Allergy and Infectious Diseases classify Bps as a Tier 1 biothreat and a category B priority pathogen.

For more information visit Soligenix.com.

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