Qpex Biopharma Announces Publication of Data in Nature Communications on Novel Synthetic Lipopeptide Antibiotic QPX9003 Targeting Multidrug-Resistant Gram-Negative Pathogens

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QPX9003 treats carbapenem-resistant pathogens for which the World Health Organization (WHO) has targeted as critical new agent needs

SAN DIEGO, March 30, 2022–(BUSINESS WIRE)–Qpex Biopharma, Inc., (Qpex), a clinical-stage biopharmaceutical company focused on antibiotic resistance that discovers and develops innovative anti-infective therapies, today announced a study published in Nature Communication on the discovery and preclinical properties of QPX9003, a novel synthetic lipopeptide antibiotic distinct from existing polymyxin-like antibiotics.

The article, “A synthetic lipopeptide targeting multidrug-resistant, gram-negative pathogens”, describes how researchers at Monash University in Melbourne, Australia, in collaboration with Qpex scientists, were able to innovate a new chemical scaffold to disconnect antimicrobial activity from nephrotoxicity, acute toxicity and inactivation by pulmonary surfactant in vitro. The resulting novel QPX9003 lipopeptide is pharmacologically distinct from existing polymyxin drugs with superior safety and efficacy against experimentally induced lung infections caused by Pseudomonas aeruginosa, Acinetobacter baumannii and Klebsiella pneumoniae.

“There is an urgent need to develop safer and more potent antibiotics that are unaffected by multi-drug resistance mechanisms,” said Professor Jian Li, Ph.D., of Monash University and lead author. item. “Our scientists gained unique insights into the pharmacological properties of polymyxin-based antibiotics that informed our strategy on how to innovate a new class of lipopeptide antibiotics.”

Currently available polymyxin antibiotics have very limited clinical utility due to significant safety concerns and poor pharmacokinetics with limited efficacy, particularly in pulmonary infections. By optimizing several non-conserved positions within the polymyxin scaffold, a new synthetic lipopeptide has been developed with studies in preclinical models showing a wider therapeutic window, reduced nephrotoxicity and acute toxicity, and exposure and improved drug efficacy compared to polymyxin B and colistin. The work described in the paper was supported in part by two R01 grants from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (R01 AI098771 and AI132154).

“The new QPX9003 synthetic lipopeptide potentially represents a significant advance in the treatment of multidrug-resistant pathogens, for which the World Health Organization (WHO) has identified a critical need for new drugs,” said Michael Dudley, PharmD, President. and Managing Director of Qpex. “The Nature Communication article and our Phase 1 progress establishes that QPX9003 has an improved profile that is needed for patients with limited treatment options. »

QPX9003 is currently completing Phase 1 studies. A single ascending dose in healthy adults has been completed with excellent safety and tolerability results. Single-dose pharmacokinetic results from a Phase 1 study will be presented at the 2022 European Conference on Clinical Microbiology and Infectious Diseases (ECCMID) in Lisbon. Clinical study and development of QPX9003 is being conducted through Qpex’s 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 of Social Services, BARDA, under OTA number HHSO100201600026C.

About Qpex Biopharma

Qpex Biopharma has three clinical-stage programs focused on the treatment of infections due to Acinetobacter spp.., Pseudomonas aeruginosaand Enterobacterales – pathogens that the CDC considers serious or urgent threats to antimicrobial resistance and that the World Health Organization (WHO) has identified as a critical need for new drugs. Development of Qpex’s portfolio products is supported in part by federal funds from the Office of the Assistant Secretary for Preparedness and Response of the United States Department of Health and Human Services, BARDA, under OTA number HHSO100201600026C.

Qpex’s clinical stage portfolio comprehensively meets the needs of patients in both inpatient and outpatient settings and includes:

  • OMNIvance®: an intravenously administered xeruborbactam product (formerly known as QPX7728) with optimal coverage of key pathogens, including those resistant to carbapenems Acinetobacter, Enterobacteriaceae and Pseudomonas.

  • ORAdvance: an orally administered combination product that delivers xeruborbactam to treat infections that occur in outpatient and community settings caused by drug-resistant gram-negative bacteria, including enterobacteriaceae resistant to fluoroquinolones, cephalosporins and carbapenems.

  • QPX9003: a next-generation, intravenously administered synthetic lipopeptide with an improved therapeutic profile designed to treat drug-resistant infections caused by Pseudomonas and Acinetobacter.

The company also has a multi-product collaboration with Brii Biosciences for the development and commercialization of these three products in Greater China. For more information, please visit www.qpexbio.com and follow us on Twitter and LinkedIn.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20220330005326/en/

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Catherine Carlyle Smith
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