Researchers at Monash University in Australia have announced a Phase I clinical trial of a new antibiotic, QPX9003, to treat infections by antibiotic-resistant bacteria or superbugs in the US.

US-based biopharmaceutical firm Qpex Biopharma has commenced the study. Qpex and Monash University team worked together to advance the antibiotic into clinical development.

Monash Institute of Pharmaceutical Sciences (MIPS) and the Monash Biomedicine Discovery Institute (BDI) discovered QPX9003.

The drug is an intravenous synthetic next-generation polymyxin developed to treat Gram-negative superbug infections.

According to the researchers, no new polymyxins received approval after polymyxin B and colistin were launched in the late 1950s.

Gram-negative bacteria, considered a global health emergency, can lead to serious infections such as pneumonia, bloodstream infections, urinary tract infections, and meningitis.

Bacterial superbugs can cause ten million deaths annually by 2050 if no new antibiotics are available for treatment, the team noted citing the World Health Organization.

Monash University antibiotic drug discovery programme head professor Jian Li said: “QPX9003 shows significantly improved safety and efficacy over the currently used polymyxin antibiotics in pre-clinical studies, in particular for lung infections.”

The Phase I trial by Qpex Biopharma will assess the safety, tolerability and pharmacokinetics of intravenous QPX9003 in healthy adults.

It is being carried out under a US investigational new drug as part of the company’s alliance with the Biomedical Advanced Research and Development Authority (BARDA).

Qpex Biopharma president and CEO Dr Michael Dudley said: “We believe the clinical candidate QPX9003 emerging from this collaboration with internationally leading scientists in polymyxin research will be the best in this class.

“This programme addresses the serious and urgent global antibiotic resistance threats in a timely manner.”

In addition to QPX9003, the company exclusively licenced global rights to other synthetic polymyxin antibiotics discovered by Monash.