The Food and Drug Administration (FDA) has granted Orphan Drug designation to pravibismane suspension for inhalation (BisEDT antimicrobial suspension; Microbion) for the management of pulmonary infections in patients with cystic fibrosis (CF).

Pravibismane, a microbial bioenergetic inhibitor, works by disrupting energy flow in bacterial membranes causing the inhibition of bacterial ATP production, which stops all downstream biosynthetic activity such as DNA, RNA, protein, cell wall and lipid synthesis. 

The investigational product has been shown to have broad-spectrum antimicrobial and antibiofilm activity against gram-negative and gram-positive pathogens with low resistance potential. Specifically, it has exhibited activity against CF-relevant pathogens including carbapenem- and multidrug-resistant Pseudomonas aeruginosa. Pre-clinical studies with the inhalation formulation of pravibismane are ongoing.

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The Company is also investigating pravibismane in a topical formulation for patients with diabetic foot ulcer and orthopedic implant infections.

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