Phase 1 Study Initiated for Drug-Resistant Gram-Negative Pathogens Therapy

QPX9003 was developed through an NIAID-supported drug discovery collaboration with world experts.

On Thursday, Qpex announced that it has begun a Phase 1 trial for QPX9003, a next generation intravenous (IV)-administered synthetic polymyxin for infections caused by drug-resistant gram-negative pathogens.

Qpex is a resistance-focused clinical-stage biopharmaceutical company discovering and developing innovative anti-infective therapies, based in San Diego, California.

“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,” Jason Pogue, clinical professor at University of Michigan said. “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.”

The United States Centers for Disease Control and Prevention (CDC), along with the World Health Organization (WHO), has stated that MDR Acinetobacter and Pseudomonas aeruginosa are serious threats to antimicrobial resistance (AMR).

The development and implementation of new therapies to treat the pathogens are a critical priority.

The Phase 1 trial is set to evaluate the safety, tolerability and pharmacokinetics of the therapy, administered intravenously in healthy adults.

The study is being conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), an office of the US Department of Health and Human Services.

“Our QPX9003 program is exemplary of how successful partnerships between industry, academia and government can advance potential treatments of AMR pathogens,” Michael Dudley, president and chief executive officer of Qpex Biopharma said. “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.”