SAN DIEGO--(BUSINESS WIRE)-- QPex Biopharma., (Qpex) a resistance-focused clinical-stage biopharmaceutical company discovering and developing innovative anti-infective therapies, announced 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.

“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.”

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.

“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.

About the Qpex Biopharma Pipeline

Qpex Biopharma has three clinical-stage programs focused on the treatment of extended-spectrum beta-lactamase (ESBL) and carbapenemase-producing pathogens that the CDC considers serious or urgent antimicrobial resistance threats, including Acinetobacter spp., Pseudomonas aeruginosa, and Enterobacteriaceae. The WHO has prioritized development of new treatments for these pathogens. Qpex’s clinical-stage portfolio comprehensively addresses patient needs in both the inpatient and outpatient settings and includes:

• OMNIvance^®: an IV-administered QPX7728-based product with best-in-class coverage of key pathogens, including carbapenem-resistant Acinetobacter, Enterobacteriaceae and Pseudomonas.
• ORAvance^™: an orally administered combination product that delivers QPX7728 to treat infections that occur in the outpatient and community setting caused by drug-resistant gram-negative bacteria, including fluoroquinolone-, cephalosporin-, or carbapenem-resistant Enterobacteriaceae.
• QPX9003: a next-generation, IV-administered synthetic polymyxin with an enhanced therapeutic profile designed to address highly drug-resistant infections caused by Pseudomonas and Acinetobacter.

About Qpex and BARDA Partnership

Qpex scientists and clinicians have an extensive track-record of successfully working with public-private partnerships, including a partnership with BARDA that led to the first approved antimicrobial drug product under that program in 2017. Qpex’s current collaboration with BARDA is focused on advancing a portfolio of novel antibiotics, including the QPX7728-based products OMNIvance and ORAvance, and QPX9003. 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; BARDA, under OTA number HHSO100201600026C.

About Monash University and NIAID-sponsored Research

Monash University is the largest university in Australia, ranked in the world’s top 100 and a member of the prestigious Group of Eight. In the 60 years since foundation, Monash University has built a reputation for world-leading and high-impact research, quality teaching, inspiring innovation and learning culture.

The NIAID/NIH Partnerships for Biodefense grants support the development of therapeutics, vaccines or medical diagnostics that address designated priority pathogens and toxins. A Partnerships for Biodefense grant (R01AI098771) was awarded to Professor Jian Li and others at Monash University to collaborate with Qpex scientists to develop improved polymyxin drugs that are effective against gram-negative ‘superbugs.’

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. Advancing a robust portfolio of best-in-class, clinical-stage products, the company’s lead programs are based on QPX7728, a novel ultra-broad-spectrum beta-lactamase inhibitor discovered by Qpex scientists, and QPX9003, a novel synthetic polymyxin antibiotic. 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.

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