● Oral and IV products based on xeruborbactam (formerly known as QPX7728), and QPX9003 are advancing in clinical studies
● All three products have received Qualified Infectious Disease Product Designation (QIDP) from the U.S. Food and Drug Administration (FDA) for multiple potential indications
● The Biomedical Advanced Research and Development Authority (BARDA) exercised a $15M option in 2021 to support continued clinical advancement of pipeline products
SAN DIEGO, January 19, 2022 – Qpex Biopharma, Inc.,(Qpex) a clinical-stage biopharmaceutical company discovering and developing
innovative anti-infective therapies, today announced continued clinical
progress of its entire pipeline and highlights the company’s strategic
“The company made superb progress in filing three Investigational New Drug applications with the US FDA within a seven-month period and made extensive progress in OMNIvance®, ORAvance™, and QPX9003 clinical programs in 2021, positioning us for multiple data catalysts in 2022,” said Michael Dudley, Pharm.D., president and chief executive officer of Qpex Biopharma. “Receipt of QIDP designations for all products from the FDA and progressing our partnerships further enables us to bring important therapies for antibiotic-resistant pathogens to patients.”
OMNIvance® (IV) and ORAvance™ (oral) are investigational products based on Qpex’s ultra-broad-spectrum beta-lactamase inhibitor xeruborbactam (formerly known as QPX7728). These products and QPX9003 (a novel synthetic polymyxin antibiotic) have each been granted Qualified Infectious Disease Product (QIDP) designation by the FDA. QIDP designation is granted by the U.S. Food and Drug Administration (FDA) for product candidates that have the potential to treat life-threatening infections due to certain qualifying pathogens, including multi-drug resistant gram-negative pathogens. Products that receive QIDP designation may receive certain incentives such as regulatory exclusivity extensions, and eligibility for fast-track designation. The QIDP designation received by all three Qpex products include multiple potential indications, including treatment of complicated urinary tract infections and ventilator-associated pneumonia.
The company also announced the exercise of a $15M option by the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response based on achievement of milestones and of its current partnership for advanced development of the company’s three clinical programs.
“In addition to these milestones,” Dudley continued, “Qpex scientists published 10 peer-reviewed articles in high-impact scientific journals over the last 12 months on our ultra-broad-spectrum beta-lactamase inhibitor, xeruborbactam. These publications, along with other analyses from external experts, consistently recognize the best-in-class microbiological properties of xeruborbactam (QPX7728).”
About the Qpex Biopharma Pipeline
Qpex Biopharma has three clinical-stage programs focused on the treatment of extended-spectrum beta-lactamase (ESBL) and carbapenemase-producing pathogens that the CDC considers serious or urgent antimicrobial resistance threats, including Acinetobacter spp., Pseudomonas aeruginosa, and Enterobacterales. The World Health Organization (WHO) has prioritized development of new treatments for these pathogens. Qpex’s clinical-stage portfolio comprehensively addresses patient needs in both the inpatient and outpatient settings and includes:
● OMNIvance®: an IV-administered xeruborbactam-based product with best-in-class coverage of key pathogens, including carbapenem-resistant Acinetobacter, Enterobacterales and Pseudomonas.
● ORAvance™: an orally-administered combination product that delivers xeruborbactam to treat infections that occur in the outpatient and community setting caused by drug-resistant gram-negative bacteria, including fluoroquinolone-, cephalosporin-, or carbapenem-resistant Enterobacterales.
● 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 Qpex and BARDA Partnership
Qpex scientists and clinicians have an extensive track-record of successfully working in public-private partnerships, including a partnership with BARDA that led to the first approved antibiotic drug product under that program in 2017. Qpex’s current collaboration with BARDA is focused on advancing a portfolio of three novel antibiotic products, including the xeruborbactam-based products OMNIvance and ORAvance, and the novel synthetic polymyxin QPX9003. The development of the products in Qpex’s portfolio is funded in whole or in part with federal funds from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, BARDA, under OTA number HHSO100201600026C. To date, BARDA has awarded $82 million and provided 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-stage products, the company’s lead program are based on xeruborbactam, a novel ultra-broad-spectrum beta-lactamase inhibitor discovered by Qpex scientists. The company currently has a partnership with BARDA to advance its portfolio 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.