Qpex Biopharma, Inc., 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.