Pravibismane nets orphan drug designation for pulmonary infections in cystic fibrosis

The FDA has granted orphan drug designation for inhalation delivery of pravibismane to treat and manage pulmonary infections in patients with cystic fibrosis, according to a press release issued by Microbion Pharma Corp.

Pravibismane (Microbion Pharma Corp.) is a first-in-class anti-infective drug with a mechanism of action that functions as a microbial bioenergetic inhibitor.

The drug exhibits broad-spectrum antimicrobial activity against cystic fibrosis-relevant pathogens, including carbapenem- and multidrug-resistant Pseudomonas aeruginosa and other multidrug-resistant pathogens that are recognized as serious threats to patients with cystic fibrosis, according to the release. In addition, pravibismane demonstrates potent activity against the microbial biofilms formed by bacterial pathogens, according to the release.

“We are pleased to have been granted orphan drug designation for our pravibismane inhalation program,” Karim Lalji, CEO and chairman of Microbion Pharma Corp, said in the release. “We will work closely with the FDA and key stakeholders to advance inhaled pravibismane toward regulatory approval for the benefit of patients with cystic fibrosis.”