FDA Grants Fast Track Designation for Melioidosis Treatment
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.