Metabolic

New antibiotic to fight deadly bacterial “superbugs” enters clinical studies

June 18, 2021

LR Associate Professor Tony Velkov, Professor Philip Thompson, Professor Jian Li, Dr. Kade Roberts, Professor Roger Nation

A critical step in addressing an urgent unmet medical need due to infections caused by antibiotic-resistant bacteria – also known as “superbugs” – is a new antibiotic (QPX9003) discovered by researchers at Monash University in the United States entered phase 1 clinical trials.

The trials were initiated by the US biopharmaceutical company Qpex Biopharma Inc. (Qpex), which worked with Monash to advance the drug’s clinical development.

QPX9003, discovered at the Monash Institute of Pharmaceutical Sciences (MIPS) and the Monash Biomedicine Discovery Institute (BDI), is a next-generation intravenous synthetic polymyxin used to treat Gram-negative “superbug” infections. No new polymyxins have been approved since the availability of polymyxin B and colistin in the late 1950s.

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

Monash’s research team 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 bring a drug from concept to clinic. QPX9003 shows significantly improved safety and efficacy in preclinical studies compared to the polymyxin antibiotics currently in use, especially for lung infections, ”said Professor Li, who leads Monash’s antibiotic research program.

“This has been an amazing journey that includes two decades of hard work in pharmacology, medicinal chemistry, and drug discovery. We are grateful 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) to fund our polymyxin drug development program. “

Dr. Michael Dudley, President and CEO of Qpex, said, “We believe that clinical candidate QPX9003 resulting from this collaboration with leading international scientists in polymyxin research will be best in its class. This program addresses the serious and urgent global threats posed by antibiotic resistance in a timely manner. We look forward to advancing QPX9003 through global development with our partners. “

MIPS Director Professor Chris Porter said, “The world desperately needs better polymyxins, so it is very exciting to see this great example of interdisciplinary collaboration enter the first phase of the clinical trial process.”

Professor John Carroll, Director of Monash BDI, said, “It is important that our discovery research translates into better health and economic gain. The partnership between Monash and Qpex is a great example of the successful commercialization of research to bring an important new antibiotic to market. “

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

For media inquiries, please contact:

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

[email protected] or +61 (0) 438 674 814

Wendy Smith, Media Manager, Monash Biomedicine Discovery Institute

[email protected] or +61 (0) 425 725 836

Katherine Carlyle Smith, Qpex Biopharma

[email protected] 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 with over 400 scientists involved in the research, development, administration and use of drugs. As part of the top-rated pharmacy school in the Asia-Pacific region, MIPS ‘therapeutic strengths lie in neuroscience and mental health, cardiovascular and metabolic health, and global health. The MIPS team is committed to research translation and has made major contributions to collaborative drug discovery programs that have brought more than 30 new drug candidates into clinical development.

About the Monash Biomedicine Discovery Institute (BDI)

The newly established Monash Biomedicine Discovery Institute at Monash University is dedicated to making discoveries that will alleviate the future burden of disease and brings together more than 120 internationally renowned research teams. With six research programs in 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. Supported by world-class technology and infrastructure, our researchers work internationally with industry, clinicians and researchers to improve lives through discovery.

About Qpex Biopharma

Qpex Biopharma, Inc. is a resistance-focused infectious disease company that aims to dramatically and sustainably improve patient care in both inpatient and outpatient settings. Qpex is further developing a portfolio of 3 novel antibiotic products in the clinic, including the QPX7728-based products OMNIvance and ORAvance as well as QPX9003 for the treatment of drug-resistant gram-negative pathogens for which the World Health Organization (WHO) has an urgent need for new drugs. The development of the products in the Qpex portfolio is financed in whole or in part with federal funds from the Ministry of Health and Social Affairs; Assistant Secretary’s Office for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under OTA number HHSO100201600026C. The company also has a multi-product partnership with Brii Biosciences for the development and marketing of three of its products in Greater China. For more information, please visit www.qpexbio.com and follow us on Twitter and LinkedIn.

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