SAN DIEGO, April 21, 2022 – Qpex Biopharma, Inc., (Qpex) a clinical-stage biopharmaceutical company discovering and developing innovative anti-infective therapies, today announced the company will present new clinical data for their β-lactamase inhibitor xeruborbactam (formerly QPX7728) and synthetic lipopeptide QPX9003 at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) being held on April 23-26, 2022.
“We are excited to present initial results from our Phase 1 clinical studies of our ultra-broad-spectrum beta-lactamase inhibitor xeruborbactam and our next-generation synthetic lipopeptide QXP9003 that was described recently in Nature Communications,” said Michael Dudley, PharmD, president and chief executive officer of Qpex. “Both of these agents represent new potential therapies for patients with drug-resistant infections – notably carbapenem-resistant Acinetobacter, Pseudomonas, and Enterobacterales for which World Health Organization (WHO) has identified as in critical need for new treatments.”
The Phase 1 clinical studies were conducted as part of Qpex’s partnership with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response under OTA number HHSO100201600026C.
Title: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of the Beta-Lactamase Inhibitor QPX7728 [xeruborbactam] Following IV Dosing in Healthy Adult Subjects
Authors: David C. Griffith, Jason A. Roberts, Steven C. Wallis, Maria Patricia Hernandez-Mitre, Elizabeth
E. Morgan, Michael N. Dudley, and Jeffery S. Loutit
Session: Oral session – Clinical and Preclinical Studies with New Antibacterials
Date & Time: April 26, 2022 from 8:30 – 10:30 a.m. CET
Title: Activity of Meropenem Combined with the β-Lactamase Inhibitor QPX7728 [xeruborbactam] and Comparator Agents Tested Against Challenging Gram-Negative Organisms
Authors: Mariana Castanheira, Jill Lindley, Yahse Edah, and Olga Lomovskaya
Session: Poster session – 5a. Mechanisms of Action, New Compounds, Preclinical Data & Pharmacology of Antibacterial Agents
Title: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of the Lipopeptide QPX9003 in Healthy Adult Subjects
Authors: David C. Griffith, Yehuda Carmeli, Shawnee Gehrke, Elizabeth E. Morgan, Michael N. Dudley, and Jeffery S. Loutit
Session: Online poster session – 5c. New or Repurposed Antibacterial Agents: Clinical Trials
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 Enterobacterales. The World Health Organization (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 xeruborbactam-based product with best-in-class coverage of key pathogens, including carbapenem-resistant Acinetobacter, Enterobacterales and Pseudomonas.
● ORAvance™: an orally-administered combination product that delivers xeruborbactam to treat infections that occur in the outpatient and community setting caused by drug-resistant gram- negative bacteria, including fluoroquinolone-, cephalosporin-, or carbapenem-resistant Enterobacterales.
● QPX9003: a next-generation, IV-administered synthetic lipopeptide with an enhanced therapeutic profile designed to focus on highly drug-resistant infections caused by Pseudomonas and Acinetobacter.
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 program are based on xeruborbactam, a novel ultra-broad-spectrum beta-lactamase inhibitor discovered by Qpex scientists. The development of the products in Qpex’s portfolio is funded in whole or in part with federal funds from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, BARDA, under OTA number HHSO100201600026C. To date, BARDA has awarded $82 million and provided technical support. The company currently has a partnership 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.