Qpex Biopharma announced today that it dosed the first patient in a Phase 1 study of its ORAvance inhibitor for bacterial infections.
San Diego-based Qpex designed its ORAvance ultra-broad-spectrum oral beta-lactamase inhibitor for use in combination with beta-lactam antibiotics for drug-resistant gram-negative bacterial infections, according to a news release.
ORAvance delivers QPX7728 in an oral administration to effectively overcome bacterial resistance mechanisms in settings where IV therapy is not possible or desirable, Qpex said. QPX7728 treats infections that occur in the outpatient and community setting caused by drug-resistant gram-negative bacteria, including ESBL and carbapenemase-producing Enterobacteriaceae.
The Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics in healthy adult participants. It is being conducted as part of Qpex’s 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.
“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,” Qpex Biopharma president & CEO Michael Dudley said in the release. “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.”