Microbion Awarded $17M to Advance Inhaled Antimicrobial Pravibismane for Lung Infections
Microbion has been awarded up to $17.1 million from the nonprofit CARB-X and the Cystic Fibrosis Foundation to complete preclinical and Phase 1 clinical studies of its inhaled antimicrobial medication pravibismane for treating cystic fibrosis (CF) patients with lung infections.
CARB-X — Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator — is a global partnership launched in 2016 and dedicated to accelerate the development of new antibiotics that address the rising challenge of drug-resistant bacteria.
Pravibismane is the first inhaled antibiotic designed to treat lung infections in CF patients and the first CARB-X has awarded. The nonprofit’s investment also will support manufacturing efforts to supply pravibismane for clinical studies.
The funding is $11.5 million — up to $6.1 million as an initial commitment plus up to $5.4 million pending attainment of milestones — from CARB-X, and up to $5.6 million from the CF Foundation. It follows pravibismane being designated recently as an orphan drug by the U.S. Food and Drug Administration (FDA) for the treatment of lung infections in CF patients.
“We are grateful for this significant support from CARB-X and the Cystic Fibrosis Foundation to investigate inhaled pravibismane as a novel approach for the management of chronic respiratory and antibiotic-resistant infections,” Karim Lalji, Microbion’s chairman, said in a press release.
“Beyond their investment, these organizations’ expertise in antibiotic-resistant infections, particularly those associated with CF, will prove valuable to advancing our technology as part of a much-needed solution to address the chronic and intractable infections that are a hallmark of CF,” Lalji added.
Pravibismane belongs to a new class of antimicrobial medications called microbial bioenergetic inhibitor agents. They have a different structure from other antibiotics and work to disrupt energy production in bacteria, preventing them from creating new DNA molecules, proteins, and cell walls, ultimately causing them to die.
In preclinical studies, the therapy has shown broad-spectrum, potent, and persistent activity against multiple bacteria that cause infections in CF patients, including the multi-drug resistant Pseudomonas aeruginosa, and the thick layer of biofilm the bacteria produce.
“Infection is a top concern of both patients and CF clinicians and remains a leading cause of lung function loss among people living with cystic fibrosis,” said William Skach, MD, chief scientific officer at CF Foundation. “As people with CF increasingly combat chronic infections and antibiotic resistance, now, more than ever before, we need novel, safe and effective anti-infectives.”
Biofilm forms a protective layer that keeps antibiotics and immune components from reaching the bacteria. Targeting these complex biofilms, that are largely responsible for the chronic and persistent lung infections in CF patients represents a unique strategy to help patients retain their lung function and improve their quality of life.
Importantly, pravibismane is able to eliminate bacteria and biofilms in the presence of CF sputum, a thick mucus layer coating the inside of the lungs.
“Microbion’s new class of anti-infective represents a novel drug that has shown potent activity against antibiotic-resistant bacterial pathogens and the biofilms these pathogens produce,” said Erin Duffy, chief of research and development at CARB-X.
“Microbion’s pravibismane, if successful and eventually approved for use in patients, has the potential to be a critical new weapon in the fight against chronic and resistant infections,” Duffy said.
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