The Cystic Fibrosis Foundation has given an additional $1.8 million to support early toxicology studies of pravibismane, Microbion’s investigational inhaled therapy for lung infections in people with cystic fibrosis (CF).
Data from these early toxicology studies, expected to conclude by mid-year, could support regulatory requests to move pravibismane into clinical testing. Together with its previous $5.6 million award, CF Foundation (CFF) funding of pravibismane’s preclinical development is now about $7.4 million.
“We are excited that the CF Foundation continues to support Microbion’s efforts toward bringing inhaled pravibismane forward to the clinic,” Karim Lalji, chairman and CEO of Microbion, said in a press release.
“The Foundation’s support underscores their commitment to assist companies with valuable, novel therapeutics that potentially improve the quality of life of patients with CF. We look forward to working closely with the Foundation to advance the IND [investigational new drug]-enabling toxicology studies,” Lalji added.
Pravibismane is reported to be the first of a new class of inhaled antimicrobials, with a distinct mechanism of action. It works as a bioenergetic inhibitor, meaning it works to prevent bacteria from producing adenosine triphosphate (ATP), the small molecule that is a main source of energy for cellular processes, and to stop cell metabolism.
In preclinical studies, pravibismane is said to have shown broad-spectrum, potent, and persistent activity against different species of bacteria known to cause lung infections in people with CF, including the multi-antibiotic resistant Pseudomonas aeruginosa.
The experimental therapy has also shown strong activity against the biofilms these bacteria produce, which are thought to contribute to the persistence that characterizes chronic CF lung infections. Biofilms are thick and protective layers of different components that deposit around bacteria, effectively preventing antibiotics or the body’s own immune cells from reaching and destroying the disease-causing microbes.
Microbion’s clinical development program for inhaled pravibismane is also being supported by the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), which awarded a grant worth to $11.5 million.
Pravibismane was named an orphan drug by the U.S. Food and Drug Administration as a potential treatment of lung infections in CF. The FDA had also designated it a qualified infectious disease product and placed it on fast track. Each of these FDA designations work to support and accelerate pravibismane’s testing and potential review for approval.
Microbion is planning to open a development program for inhaled pravibismane as a treatment for non-tuberculous mycobacteria lung disease.
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