Qpex Biopharma, a Shionogi Company, Gets $10M from BARDA to Advance Antibiotics for Drug-Resistant Infections

QPex Biopharma, Inc., a part of the Shionogi Group, has announced that it has secured a $10 million option from the Biomedical Advanced Research and Development Authority (BARDA). This funding is part of an overarching contract with BARDA, which could potentially provide up to $132 million to support QPex’s antibiotic clinical development program. The initiative is a part of the Administration for Strategic Preparedness and Response under the U.S. Department of Health and Human Services.

Michael N. Dudley, Pharm.D., President and CEO of QPex, emphasized the significance of this award in continuing the company's efforts in antibiotic development. He noted that this progress stems from the substantial advancements made since merging with Shionogi in the previous year. Dudley expressed gratitude for the ongoing partnership with BARDA, which is pivotal in driving forward QPex’s development programs. Shionogi has a long history of creating and commercializing innovative anti-infective products, which bolsters the collaboration’s potential.

The newly awarded BARDA funds will be utilized to further the development of xeruborbactam, an investigational beta-lactamase inhibitor. This includes supporting clinical studies for both intravenous (IV) and oral combinations targeting drug-resistant gram-negative bacterial infections.

John Keller, Ph.D., Senior Executive Officer and Senior Vice President of the R&D Supervisory Unit at Shionogi, stressed the urgency of addressing antimicrobial resistance on a global scale. He highlighted that antibiotic development has not been keeping pace with the growing resistance. Keller believes that the combination of QPex's promising drug pipeline and Shionogi's extensive research history in infectious diseases has the potential to expedite essential solutions for drug-resistant infections.

According to the Centers for Disease Control (CDC), over 2.8 million antibiotic-resistant infections occur annually in the U.S. Many of these infections are caused by drug-resistant gram-negative bacteria, which QPex’s portfolio specifically targets.

QPex was acquired by Shionogi Inc., a subsidiary of Shionogi & Co., Ltd., in 2023. This merger has brought together leading teams and has significantly enhanced research capabilities, strengthening Shionogi's global efforts in developing necessary antimicrobials. The senior leadership team at QPex has a long history of collaboration, having secured four regulatory approvals in the past decade. Within the first three years of operation, QPex has advanced three products to the U.S. investigational new drug (IND) application stage.

QPex Biopharma, Inc. is dedicated to addressing infectious diseases with a focus on antibiotic resistance, aiming to significantly improve patient care both in hospital and outpatient settings. Its primary program revolves around xeruborbactam, an ultra-broad-spectrum beta-lactamase inhibitor discovered by QPex scientists.

Qpex has a track record of successful public-private partnerships, including previous collaborations with BARDA. The current partnership aims to advance products like S-649228 (a combination of cefiderocol and xeruborbactam for IV use) and S-743229 (a combination of ceftibuten and xeruborbactam for oral use). The development of these products is partially funded by federal funds from the U.S. Department of Health and Human Services, under an agreement that could ultimately total $132 million in support.

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