Policy & Regulation
Qpex Biopharma Initiates Phase 1 Study of ORAvance for Oral Treatment of Drug-Resistant Gram-Negative Bacterial Infections
12 May 2021 - - 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, US-based clinical-stage biopharmaceutical company Qpex Biopharma, Inc said.

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 US Department of Health and Human Services.

Qpex Biopharma has three development programs focused on the treatment of drug-resistant pathogens that the Center for Disease Control considers serious or urgent antimicrobial resistance threats, including Acinetobacter spp., Pseudomonas aeruginosa, and Enterobacteriaceae.

The World Health Organization 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 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 USD67 m and technical support. If all options are awarded, the agreement would provide up to USD 132m in support for the development of a portfolio of new antibiotics to fight drug-resistant gram-negative infections.

Qpex Biopharma 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.
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