Le Lézard
Classified in: Health, Science and technology
Subject: Product/Service

Qpex Biopharma Announces Progress on Three Clinical Stage Programs for Antibiotic-Resistant Pathogens and Corporate Update


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 advancements.

"The company made superb progress in filing three Investigational New Drug applications with the U.S. 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 ORAvancetm (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 U.S. Food and Drug Administration (FDA). QIDP designation is granted by the 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:

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.


These press releases may also interest you

at 12:05
Regulatory News: MaaT Pharma (EURONEXT: MAAT ? the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem Therapies dedicated to improving survival outcomes for patients with cancer today announced that...

at 12:05
Activ Surgicaltm, a digital surgery pioneer, today announced the successful completion of an Institutional Review Board (IRB) study using its ActivSighttm intraoperative imaging module at the Jacobs School of Medicine and Biomedical Sciences at the...

at 12:05
The "WAN Optimization Market Research Report by Component (Services and Solution), Solution, Service, Deployment Mode, End User, Vertical, Region (Americas, Asia-Pacific, and Europe, Middle East & Africa) - Global Forecast to 2027 - Cumulative Impact...

at 12:05
Today, Ridge Ventures, a seed and early-stage, enterprise-focused venture capital firm whose investments include Bolt, Braze, and Discord, announced that Partner Akriti Dokania has joined its team. Dokania will contribute to the firm's enterprise...

at 12:05
Cequence Security, a leader in API security, today announced that the Cequence Customer Success Team has been recognized as an Excellence Award finalist in the Best Customer Service category for the 2022 SC Awards. Now in its 25th year, the SC Awards...

at 12:05
Agnetix, a leader in Smart Horticulture Lighting, has added a Canadian subsidiary to better serve the burgeoning market interested in their innovative, high-powered, liquid-cooled luminaires. Operations commenced May 1, 2022 in southern Ontario....



News published on 19 january 2022 at 08:10 and distributed by: