Venatorx Pharmaceuticals, Inc., a GARDP collaborator, today announced positive results from its pivotal phase 3 study evaluating cefepime-taniborbactam as a treatment for hospitalized adult patients with complicated urinary tract infections, including acute pyelonephritis (i.e. kidney infections). Cefepime-taniborbactam offers a potential treatment option for patients with serious infections caused by highly resistant bacteria, even those resistant to last-resort carbapenem antibiotics. Since April 2020, GARDP and Venatorx have been working together to accelerate the development of cefepime-taniborbactam, and the New Drug Application is on track to be filed with the US Food and Drug Administration in the fourth quarter of 2022. If approved, cefepime-taniborbactam will be the first new antibiotic treatment to be launched in collaboration with GARDP since its foundation.

Since it was introduced in the 1990s, the antibiotic cefepime (known as a “beta-lactam” because of its chemical structure) has faced growing resistance from bacteria that produce special enzymes (beta-lactamases), which break down antibiotics like cefepime that had the potential to destroy them. Taniborbactam (a potent beta-lactamase inhibitor) shields cefepime against these destructive enzymes for renewed activity. This new investigational beta-lactam/beta-lactamase inhibitor combination (cefepime-taniborbactam) has activity against carbapenem-resistant Enterobacterales and carbapenem-resistant Pseudomonas aeruginosa, which have been identified as priority pathogens in urgent need of new treatments by the World Health Organization.

“We are very pleased to collaborate with Venatorx to advance the development of a new treatment for serious bacterial infections,” said Subasree Srinivasan, Medical Director of GARDP. “The positive phase 3 clinical trial results bring cefepime-taniborbactam closer to becoming a potential treatment option for patients with infections caused by some of the most difficult-to-treat bacteria. Public-private partnerships, with crucial support from donors, enable GARDP to deliver solutions as soon as possible for people who are disproportionately affected by antibiotic resistance, such as newborns and seriously ill patients in low- and middle-income countries.” GARDP’s contribution to the trial was made possible with support from the German, UK, Japanese, Dutch, Swiss, and South African governments, as well as from the Leo Model Foundation.

“These data demonstrate that cefepime-taniborbactam represents a significant improvement over the standard of care and will support global health efforts to combat antibiotic-resistant infections,” said Christopher J. Burns, President and CEO of Venatorx. “We want to thank the patients who enrolled in the trial, the clinical investigators who participated in the study, as well as our employees and our partners, like GARDP, for their steadfast support and determination to bring lifesaving cures to patients around the world.”

GARDP and Venatorx are committed to working together to develop cefepime-taniborbactam for use in adults and children and to distribute it on an affordable basis worldwide. Under the collaboration and license agreement, Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in certain low- and lower middle-income countries, as well as in the public markets in India and South Africa. The results of this phase 3 trial bring GARDP one step closer to making a new antibiotic treatment accessible for people of all ages affected by serious bacterial infections around the world.

About GARDP

The Global Antibiotic Research and Development Partnership (GARDP) is a Swiss not-for-profit organization developing new treatments for drug-resistant infections that pose the greatest threat to health. GARDP was created in 2016 by the World Health Organization (WHO) and the Drugs for Neglected Diseases initiative (DNDi) and legally founded in 2018 to ensure that everyone who needs antibiotics receives effective and affordable treatment, no matter where they live. It aims to develop new treatments to fight drug-resistant infections, with a focus on sexually transmitted infections, sepsis in newborns and infections in hospitalized adults and children. GARDP is funded by the governments of Germany, Japan, Luxembourg, Monaco, Netherlands, South Africa, Switzerland, United Kingdom, the Canton of Geneva, as well as Médecins Sans Frontières and private foundations. GARDP is registered under the legal name GARDP Foundation. www.gardp.org

About Venatorx Pharmaceuticals, Inc.

Venatorx is a private, clinical-stage pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections. Venatorx’s lead program, cefepime-taniborbactam, is a clinical-stage intravenous antibiotic that completed a Phase 3 study in adults with complicated urinary tract infections. Based on positive results from the CERTAIN-1 Phase 3 clinical trial, the Company expects to file a New Drug Application with the U.S. Food and Drug Administration for cefepime-taniborbactam in the fourth quarter 2022. Venatorx also has an oral antibacterial clinical-stage program, ceftibuten/VNRX-7145, that is in Phase 1. For more information about Venatorx and its anti-infectives portfolio, please visit www.venatorx.com.