DIEGO, December 3, 2020 – Qpex Biopharma, Inc., a clinical-stage
biopharmaceutical company focused on the discovery and development of
innovative anti-infective therapies, announced today that it has
initiated a Phase 1 clinical study of QPX7728, its novel
ultra-broad-spectrum beta-lactamase inhibitor.
marks another important milestone for Qpex as we begin advancing 3
novel product candidates into clinical trials during the coming months”,
said Michael Dudley, Pharm.D., President and CEO of Qpex Biopharma. “We
believe that QPX7728 has demonstrated a preclinical profile that
exceeds that of recently marketed beta-lactamase inhibitors as well as
those in ongoing clinical trials. Our team, consisting of scientists and
clinicians that rapidly brought the first agent from the cyclic boronic
acid class from discovery to patients during the last decade, is poised
to rapidly advance QPX7728 in the clinic with the continued support of
Phase 1 study will investigate the safety and pharmacokinetics of
QPX7728 alone following single and multiple intravenous doses, and in
combination with a beta-lactam antibiotic in healthy adult subjects.
is an ultra-broad-spectrum beta-lactamase inhibitor discovered by Qpex
scientists. Beta-lactamases are bacterial enzymes that destroy
beta-lactam antibiotics and are the major mechanism of resistance to
these drugs in gram-negative bacteria. Unlike other inhibitors, QPX7728
inhibits serine- and metallo-beta lactamases of Classes A, B, C, and D
in Acinetobacter spp., Pseudomonas aeruginosa, and Enterobacteriaceae.
QPX7728 is also active against beta-lactamases that are resistant to
inhibition by avibactam. This spectrum of inhibition, coupled with a low
sensitivity of QPX7728 to multi-drug resistance mechanisms like efflux
and permeability as compared to other agents, allows QPX7728 to restore
the potency of multiple beta-lactam antibiotics against drug-resistant
Acinetobacter spp., Pseudomonas aeruginosa, and Enterobacteriaceae.
QPX7728 can be delivered by oral or intravenous administration.
QPX7728 is an integral part of a portfolio of products being developed to comprehensively address patient needs associated with drug-resistant gram-negative infections and currently enables two product candidates in the Qpex pipeline:
● OMNIvanceÔ: an IV-administered QPX7728-based product with best-in-class coverage of key pathogens, including carbapenem-resistant Acinetobacter, Enterobacteriaceae and Pseudomonas.
● ORAvanceÔ: an orally-administered combination product based on QPX7728
to treat infections that occur in the outpatient and community setting
caused by drug-resistant gram-negative bacteria, including
extended-spectrum beta-lactamase (ESBL)- and carbapenemase-producing
About Biomedical Advanced Research and Development Authority (BARDA) Partnership
scientists and clinicians have an extensive track-record of
successfully working with public-private partnerships, including
partnerships with BARDA that led to the first approved antimicrobial
drug product under that program in 2017. The advancement of QPX7728
into the clinic is part of Qpex’s current partnership with BARDA that is
focused on advancing a portfolio of novel antibiotics, including the
QPX7728-based products OMNIvance and ORAvance. The development of the
products in this 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. The agreement provides for up to $132 million in
support for the development of a portfolio of new antibiotics to fight
drug-resistant gram-negative infections.
About Brii Biosciences Partnership
Biopharma and Brii Biosciences have entered into a strategic
collaboration to develop and commercialize three of Qpex’s
investigational products, including QPX7728-based products, to treat a
range of multi-drug resistant gram-negative infections in greater
China. Under the terms of the agreement, Brii obtained a license to
develop, manufacture, and commercialize these products in greater China,
which includes Taiwan, Hong Kong, Macau and the People’s Republic of
China. Qpex retained all other rights globally, including the U.S. and
Europe. In addition to the initial upfront payment, Brii will make
success-based development, regulatory and commercial milestone payments,
and share in the costs of a global development program. Qpex will also
receive tiered royalties on sales in the Brii territory.
About Antimicrobial Resistance (AMR)
2019, the US Center for Disease Control and Prevention (CDC) estimated
that over 2.8 million antibiotic-resistant infections occur every year.
Among the most serious and difficult to treat infections are those
caused by drug-resistant gram-negative bacteria, which are considered by
the CDC to be serious-to-urgent resistance threats. The Qpex pipeline
is designed to target these most serious and urgent resistance threat
pathogens, including ESBL- and carbapenemase-producing
Enterobacteriaceae (CRE) which are found in the community as well as
hospital setting, and carbapenem-resistant strains of Acinetobacter, and
About Qpex Biopharma
Qpex Biopharma, Inc. is a clinical-stage biopharmaceutical company with a pipeline of best-in-class agents addressing critical needs for treatment of infectious diseases in both the inpatient and outpatient settings. The company’s lead program is based upon QPX7728, a novel ultra-broad-spectrum beta-lactamase inhibitor discovered by Qpex scientists. Qpex was launched in 2018 with investments from New Enterprise Associates, Adams Street Partners, LYZZ Capital, Hatteras Venture Partners, and Stanford University Draper Fund as well as funding provided through an agreement with the Biomedical Advanced Research and Development Authority (BARDA). Qpex has 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.