FDA grants fast track designation to SGX943 for melioidosis

The FDA has granted fast track designation to SGX943 as an adjunctive therapy for the treatment of melioidosis, according to a press release from the experimental treatment’s manufacturer.

SGX943 (dusquetide, Soligenix) is an innate defense regulator that can modulate host responses to increase survivability after several gram-negative or gram-positive infections, according to the release. Before this designation the novel treatment demonstrated safety in a phase 1 trial of 84 participants, and efficacy in a phase 2 trial of 111 oral mucositis patients.

This designation will allow Soligenix to submit a new drug application for dusquetide on a rolling basis and will grant the experimental therapy eligibility for priority review.

“We believe that the FDA’s action in granting fast track designation validates the unmet medical need that currently exists for the treatment of melioidosis and for the potential key role SGX943 can serve as a therapy in this rare, life-threatening disease,” Christopher J. Schaber, PhD, president and CEO of Soligenix, said in the press release. “We look forward to working with the federal government to advance this biodefense development program.”

Melioidosis is an acute disease characterized by a fulminant pneumonia and is caused by the gram-negative bacillus Burkholderia pseudomallei. According to the release, it is also considered a possible biological warfare agent by the HHS due to its potential for widespread dissemination through aerosol.

Disclosure: Schaber is an employee of Soligenix.