Health

Anti-infective therapy for infections caused by drug-resistant gram-negative pathogens now in Phase I study



By NewsDesk  @infectiousdiseasenews

Biopharmaceutical company, Qpex Biopharma, announced this week the initiation of a Phase 1 study of QPX9003, a next generation intravenous (IV)-administered synthetic polymyxin for infections caused by drug-resistant gram-negative pathogens.

Acinetobacter spp./CDC

“Infections due to multidrug-resistant (MDR) Acinetobacter sp. and Pseudomonas aeruginosa have resulted in an increased reliance on polymyxin antibiotics originally discovered over 60 years ago,” stated Jason Pogue, PharmD, clinical professor at University of Michigan. “Our research shows that nephrotoxicity occurs in roughly 40% of patients treated with currently available polymyxins, and thus there is a significant unmet need for less toxic therapies.”

“Our team’s experience with and insights into the polymyxin drug class allowed us to innovate QPX9003, a novel synthetic polymyxin with greatly enhanced pharmacological properties and potency against target pathogens,” said Jian Li, PhD, research professor at Monash University; head of the Antimicrobial Systems Pharmacology Laboratory at the Biomedicine Discovery Institute; and principal investigator on the National Institute of Allergy and Infectious Diseases (NIAID)-sponsored antibiotic discovery program (NIAID R01AI098771). “QPX9003 has shown reduced toxicity compared to the currently used polymyxin B and colistin in preclinical studies. This property, coupled with greater antimicrobial potency, is expected to translate to improved effectiveness for patients with MDR gram-negative infections.”

Michael Dudley, PharmD, president and chief executive officer of Qpex Biopharma added, “Our QPX9003 program is exemplary of how successful partnerships between industry, academia and government can advance potential treatments of AMR pathogens. QPX9003 was discovered through a NIAID-supported drug discovery collaboration with world experts in polymyxin pharmacology and medicinal chemistry at Monash University, and then transitioned into our development portfolio as part of our partnership with the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response of the U.S. Department of Health and Human Services.”

The Phase 1 trial will evaluate the safety, tolerability and pharmacokinetics of QPX9003 administered intravenously in healthy adults. The study is being conducted under a U.S. investigational new drug (IND) as part of the company’s partnership with BARDA.

The Centers for Disease Control and Prevention (CDC) has listed MDR Acinetobacter and Pseudomonas aeruginosa as serious antimicrobial resistance (AMR) threats, and the World Health Organization considers the development of new drugs to treat these pathogens to be a critical priority.


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