New antibiotic to combat deadly bacterial ‘superbugs’ enters clinical trials

L-R Associate Professor Tony Velkov, Professor Philip Thompson, Professor Jian Li, Dr Kade Roberts, Professor Roger Nation
L-R Associate Professor Tony Velkov, Professor Philip Thompson, Professor Jian Li, Dr Kade Roberts, Professor Roger Nation

In a critical step towards addressing an urgent unmet medical need due to infections caused by antibiotic-resistant bacteria - also known as ‘superbugs’ - a new antibiotic (QPX9003) discovered by Monash University researchers has entered Phase 1 clinical trials in the United States.

The trials have been initiated by the US-based biopharmaceutical company Qpex Biopharma Inc. (Qpex) who have worked in collaboration with Monash to drive clinical development of the drug.

QPX9003, which was discovered at the Monash Institute of Pharmaceutical Sciences (MIPS) and the Monash Biomedicine Discovery Institute (BDI), is an intravenously-administered synthetic next-generation polymyxin for treating Gram-negative ‘superbug’ infections. No new polymyxins have been approved since polymyxin B and colistin became available in the late 1950s.

Deemed a global health crisis, Gram-negative bacteria can cause serious infections, including pneumonia, bloodstream infections, urinary tract infections, peritonitis and meningitis. The World Health Organization has highlighted that new antibiotics are urgently needed to treat bacterial ‘superbugs’, which have the potential to kill 10 million people per year by 2050 – more than any other type of disease.

The team of Monash researchers is led by Professor Jian Li, Associate Professor Tony Velkov, Professor Roger Nation, Dr Kade Roberts and Professor Philip Thompson.

“This is a remarkable achievement for our team, to take a drug from concept into the clinic. QPX9003 shows significantly improved safety and efficacy over the currently used polymyxin antibiotics in pre-clinical studies, in particular for lung infections,” said Professor Li who heads up the Monash antibiotic drug discovery program.

“This has been an amazing journey involving two decades of hard work across pharmacology, medicinal chemistry and drug discovery. We’re very thankful for the efforts of our team here at Monash, the support of Monash Innovation, our productive collaboration with Qpex and the US National Institute of Allergy and Infectious Diseases (NIAID, R01AI098771) for funding our polymyxin drug development program.”

Dr Michael Dudley, President and CEO of Qpex 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 program addresses the serious and urgent global antibiotic resistance threats in a timely manner. We look forward to advancing QPX9003 through global development with our partners”.

Director of MIPS, Professor Chris Porter said: “The world desperately needs better polymyxins, so it’s very exciting to see this great example of cross-disciplinary collaboration reach the first stage of the clinical trial process.”

Professor John Carroll, Director of Monash BDI, said: “  It is important that our discovery research is translated into improving health and economic gain. The Monash-Qpex partnership is a great example of successful research commercialisation to help bring a critical new antibiotic to the market.”

The next-generation polymyxin research program was initiated with a Monash Research Impact Fund in 2008 and was funded by a five-year US National Institutes of Health R01 grant. Monash’s portfolio of proprietary synthetic polymyxin antibiotics (including QPX9003) was exclusively licenced to Qpex for worldwide rights to develop and commercialize in multiple territories.

For media enquiries contact:

Kate Carthew, Media Manager, Monash Institute of Pharmaceutical Sciences.

kate.carthew@monash.edu or +61 (0) 438 674 814

Wendy Smith, Media Manager, Monash Biomedicine Discovery Institute

wendy.smith1@monash.edu or +61 (0) 425 725 836

Katherine Carlyle Smith, Qpex Biopharma

Katherine.smith@canalecomm.com or +1 619-849-5378


About the Monash Institute of Pharmaceutical Sciences (MIPS)

The Monash Institute of Pharmaceutical Sciences is a dynamic, innovative and ambitious research institute, comprising over 400 scientists engaged in research in drug discovery, design, delivery and use. As part of the top ranked Pharmacy Faculty in the Asia Pacific, MIPS’ therapeutic strengths lie in neuroscience and mental health, cardiovascular and metabolic health and global health. The team at MIPS are committed to research translation and have made major contributions to collaborative drug discovery programs that have progressed more than 30 novel drug candidates into clinical development.

About the Monash Biomedicine Discovery Institute (BDI)

Committed to making the discoveries that will relieve the future burden of disease, the newly established Monash Biomedicine Discovery Institute at Monash University brings together more than 120 internationally-renowned research teams. Spanning six discovery programs across Cancer, Cardiovascular Disease, Development and Stem Cells, Infection and Immunity, Metabolism, Diabetes and Obesity, and Neuroscience, Monash BDI is one of the largest biomedical research institutes in Australia. Our researchers are supported by world-class technology and infrastructure, and partner with industry, clinicians and researchers internationally to enhance lives through discovery.

About Qpex Biopharma

Qpex Biopharma, Inc. is a resistance-focused infectious disease company on a mission to make both a dramatic and sustainable improvement in patient care across both inpatient and outpatient settings. Qpex is advancing a portfolio of 3 novel antibiotic products in the clinic, including the QPX7728-based products OMNIvance and ORAvance, and QPX9003 for treatment of drug-resistant gram-negative pathogens for which the World Health Organization (WHO) considers there to be a critical need for new drugs. The development of the products in Qpex’s portfolio is funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under OTA number HHSO100201600026C. The company also has a multi-product collaboration with Brii Biosciences for the development and commercialization of three of its products in greater China. For more information, please visit www.qpexbio.com and follow us on Twitter and LinkedIn.