Qpex Biopharma Announces Presentations on Phase 1 and Nonclinical Data on Three Clinical Stage Oral and IV Products Targeting Antibiotic-Resistant Bacterial Infections at 2022 ID Week Meeting
SAN DIEGO, October 17, 2022 – Qpex Biopharma today announced that clinical and preclinical data on its portfolio of clinical stage investigational antibiotic programs will be featured in several presentations at the upcoming 2022 ID Week Meeting in Washington, DC on October 19-23.
The presentations will describe progress on three Qpex investigational products that the recent WHO pipeline analysis identified as addressing drug-resistant pathogens for which there is a critical need for new drugs.
In addition to clinical data, microbiological results with the beta-lactamase inhibitor xeruborbactam in combination with multiple companion beta-lactams from comparative head-to-head studies against other marketed and investigational IV and oral products using recent clinical isolates of multi-drug resistant gram-negative bacteria will be presented.
“These studies show that the microbiological profile of our ultra-broad-spectrum beta-lactamase inhibitor xeruborbactam in combination multiple beta-lactams exceeds that for other investigational or marketed agents,” stated Michael Dudley, PharmD, FIDSA, president and chief executive officer of Qpex Biopharma. “We will also provide the first presentation of clinical results and PK-PD data from our ORAvance product that delivers xeruborbactam as an oral prodrug with the oral cephalosporin ceftibuten that is being investigated for potential once-daily treatment of certain gram-negative infections, including those due ESBL- and carbapenemase-producing Enterobacterales.”
ID Week 2022 is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), the Society of Infectious Diseases Pharmacists (SIDP), and the Pediatric Infectious Diseases Society (PIDS). The meeting will be conducted in person in Washington, DC and online. Further information may be found at https://idweek.org.
Presentations on Qpex products are listed below. All times listed below are in Eastern Daylight Time.
Date: Thursday October 20, 2022
Presentation Location: Walter E. Washington Convention Center in Exhibit Hall BC
Time: 12:15 PM - 1:30 PM
Session Title: Clinical Trials
A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of the Beta-lactamase Inhibitor Xeruborbactam Alone and in Combination Meropenem in Healthy Adult Subjects (Poster 216)
David C. Griffith, Jason A. Roberts, Steven C. Wallis, Maria Patricia Hernandez-Mitre, Elizabeth E. Morgan, Shawnee Gehrke, Michael N. Dudley, and Jeffery S. Loutit
A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of the Lipopeptide QPX9003 in Healthy Adult Subjects (Poster 217)
David C. Griffith, Yehuda Carmeli, Shawnee Gehrke, Elizabeth E. Morgan, Michael N. Dudley, and Jeffery S. Loutit
A Phase 1 Study of the Single-Dose Safety, Tolerability, and Pharmacokinetics of the Beta-lactamase Inhibitor Xeruborbactam Administered as the Isobutyryloxymethyl Oral Prodrug to Healthy Adult Subjects (Poster 218)
David C. Griffith, Jason A. Roberts, Steven C. Wallis, Maria Patricia Hernandez-Mitre, Elizabeth E. Morgan, Michael N. Dudley, and Jeffery S. Loutit
Session Title: PK/PD Studies
Pharmacodynamics (PD) of the Beta-Lactamase Inhibitor Xeruborbactam When Administered as the Oral Prodrug in Combination with Ceftibuten (Poster 614)
Ziad Tarazi, Niki Roos, Ted Page, and David C. Griffith
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Pharmacodynamics (PD) of the Beta-Lactamase Inhibitor Xeruborbactam When Administered in Combination with Meropenem (Poster 615)
Ziad Tarazi, Niki Roos, Ted Page, and David C. Griffith
Pharmacodynamics (PD) of the Lipopeptide QPX9003 Against Acinetobacter baumannii and P. aeruginosa in the Neutropenic Mouse Thigh Infection Model (Poster 616)
Ziad Tarazi, Niki Roos, Ted Page, Jian Li, J. Wang, Kade D. Roberts and David C. Griffith
Date: Saturday October 22, 2022
Presentation Location: Walter E. Washington Convention Center in Exhibit Hall BC
Time: 12:15pm – 1:30pm
Session Title: Antimicrobial Novel Agents
Ceftibuten-Xeruborbactam: In Vitro Potency against Enterobacterales in Comparison with Other Oral Beta-lactams (BL) and Beta-lactamase Inhibitor (BLI) Combinations (Poster 1692)
Olga Lomovskaya, Mariana Castanheira, and Jill Lindley
Meropenem-Xeruborbactam: In Vitro Potency against Gram-Negative Bacteria in Comparison with Marketed and Investigational Beta-lactam (BL)/Beta-lactamase Inhibitor (BLI) Combinations (Poster 1693)
Olga Lomovskaya, Mariana Castanheira, and Jill Lindley
Xeruborbactam (QPX) Potentiates the Activity of β-Lactam Antibiotics Against a Diverse Group of Highly Drug-Resistant Enterobacterales (Poster 1737)
Anthony Newbrough, Giuseppe Fleres, Binghua Hao, Liang Chen, Ryan K Shields, Cornelius J Clancy, and M. Hong Nguyen
Xeruborbactam (QPX) Potentiates the Activity of Multiple β-lactams Against Highly Resistant Pseudomonas aeruginosa to a Greater Degree than Other Beta-Lactamase Inhibitors (Poster 1736)
Giuseppe Fleres, Anthony Newbrough, Binghua Hao, Liang Chen, Ryan K Shields, Cornelius J Clancy, and M. Hong Nguyen
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 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:
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OMNIvance®: an IV-administered xeruborbactam-based product with best-in-class coverage of key pathogens, including carbapenem-resistant Acinetobacter, Enterobacterales and Pseudomonas.
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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.
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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.
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 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’ Administration for Strategic Preparedness and Response, BARDA, under OTA number HHSO100201600026C. To date, BARDA has awarded $82 million and provided technical support. The company also 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.
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