Qpex Biopharma, Inc., (Qpex) a resistance-focused clinical-stage biopharmaceutical company discovering and developing innovative anti-infective therapies, announced that the first patient has been dosed in a Phase 1 study of ORAvance™, an ultra-broad-spectrum oral beta-lactamase inhibitor for use in combination with beta-lactam antibiotics for drug-resistant gram-negative bacterial infections.
"Fluoroquinolones were previously the mainstay of oral treatments for gram-negative infections, but increasing safety concerns and rising resistance rates for those agents have forced physicians to use alternatives such as IV therapies in the hospital or outpatient infusion centers," said Michael Dudley, Pharm.D., president and chief executive officer of Qpex Biopharma. "ORAvance provides convenient oral delivery of QPX7728, our ultra-broad-spectrum beta-lactamase inhibitor that is also progressing in Phase 1 clinical trials in an IV form."
Cornelius Clancy, MD, Professor of Medicine, University of Pittsburgh added, "Extended-spectrum beta-lactamase (ESBL) and carbapenemase-producing Enterobacteriaceae can be resistant to currently available oral and IV antibiotics, creating a significant challenge for patients and their treating clinicians. There is critical need particularly for new oral drugs to address this very serious public health threat that avoids the need for hospitalization or allows patients to return home more quickly."
Building upon Qpex’s validated beta-lactamase inhibitor technology that led to FDA approval of the first member of this new drug class, ORAvance is an oral combination product that delivers QPX7728 by the oral route of administration, and has the potential to be a new effective treatment option that overcomes bacterial resistance mechanisms in settings where IV therapy is not possible or desirable. The Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics in healthy adult participants.
The study is being conducted as part of its partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
About the Qpex Biopharma Pipeline
Qpex Biopharma has three development programs focused on the treatment of drug-resistant pathogens that the Center for Disease Control (CDC) considers serious or urgent antimicrobial resistance threats, including Acinetobacter spp., Pseudomonas aeruginosa, and Enterobacteriaceae. The World Health Organization (WHO) has also prioritized development of new treatments for these pathogens. Qpex’s portfolio comprehensively addresses patient needs in both the inpatient and outpatient settings. Two of the products use QPX7728, an ultra-broad-spectrum beta-lactamase inhibitor that restores the potency of beta-lactam antibiotics in vitro and in vivo. The products are:
OMNIvance®: an IV-administered QPX7728-based product (currently in Phase 1) 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 ESBL and carbapenemase-producing 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 Biomedical Advanced Research and Development Authority (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. 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; Biomedical Advanced Research and Development Authority (BARDA), under OTA number HHSO100201600026C. To date, BARDA has provided $67 million and technical support. If all options are awarded, the agreement would provide up to $132 million in support for the development of a portfolio of new antibiotics to fight drug-resistant gram-negative infections.
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 candidates, the company’s lead program is based on QPX7728, a novel ultra-broad-spectrum beta-lactamase inhibitor discovered by Qpex scientists. The company currently has a partnership with Biomedical Advanced Research and Development Authority (BARDA) focused on advancing novel antibiotics and 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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Katherine Carlyle Smith