Monash University announced today the grant of an exclusive licence of its portfolio of proprietary synthetic polymyxin antibiotics to Qpex Biopharma, a US-based biopharmaceutical company focused on developing new antibiotics to combat the growing threat of global antimicrobial resistance.
The novel polymyxin antibiotics have been developed by researchers at the Monash Institute of Pharmaceutical Sciences (MIPS) and the Monash Biomedicine Discovery Institute (BDI), led by Professor Jian Li, Associate Professor Tony Velkov, Professor Roger Nation, Dr Kade Roberts and Professor Philip Thompson. These researchers are world leaders in polymyxin pharmacology and medicinal chemistry.
The research team have identified a promising lead candidate that is currently being evaluated ahead of application to the US Food and Drug Administration. Qpex intends to take the drug candidate in to a Phase 1 clinical trial.
The development of the new polymyxin is designed to meet an increasingly urgent healthcare need. By 2050, antimicrobial-resistant infections may kill 10 million people per year. The World Health Organization (WHO) identified a Priority Pathogen List for which new antibiotics are urgently needed. Gram-negative 'superbugs' are at the top of the list and present a major global health challenge.
This challenge has been further compounded by the lack of development of new antibiotics targeting these Gram-negative bacteria. As a result, the available polymyxin antibiotics are often the only option available for doctors to treat pathogens that are resistant to all other antibiotics. However, kidney toxicity and poor efficacy against lung infections have significantly limited their clinical use.
Due to their toxic nature, no new polymyxins have been approved for use since the 1950s.
"The world desperately needs better polymyxins and our novel synthetic polymyxins show superior efficacy and safety over the existing polymyxin drugs in pre-clinical animal studies. We are thrilled with the partnership
with Qpex which will now pursue the clinical development of these promising new polymyxin analogues," said Professor Li, who heads the Monash polymyxin drug development research.
"We are very grateful to the NIH for funding our discovery program, and many group members for their hard work over the years."
"This is a great example of the potential for cross-disciplinary collaboration and the power of support for drug discovery by national and international funding agencies, as well as industry," said Professor Chris Porter, Director the Monash Institute of Pharmaceutical Sciences.
Doctor Michael Dudley, PharmD, President and CEO of Qpex Biopharma said, "We believe the new polymyxin clinical drug candidate emerging from this collaboration will have an improved profile over other members of this class.
This program joins our internal pipeline of products under development to address serious and urgent resistance threats. We look forward to advancing these programs in development within our partnership with Biomedical Advanced Research and Development Authority (BARDA)."
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