New cefepime-taniborbactam clinical data to be presented in oral presentation
Malvern, PA, October 19, 2022 – Venatorx Pharmaceuticals, a private, clinical-stage pharmaceutical company focused on improving health outcomes for patients with difficult-to-treat drug resistant gram-negative bacteria infections and viral infections with limited treatment options, today announced six presentations during IDWeek 2022, October 19-23, 2022, in Washington, DC for its novel antibiotic cefepime-taniborbactam, including 2 oral presentations showcasing cefepime-taniborbactam and highlighting the safety and efficacy results from our recently completed pivotal Phase 3 complicated urinary tract infection (cUTI) clinical trial, CERTAIN-1.
Presentation Details
Title: Oral presentation: Cefepime-Taniborbactam
Date/Time: October 20, 2022, 8:00 am – 9:00 am
Session Title: New Antimicrobials and ID Diagnostics in the Pipeline – Bacterial
Session Location: 145 AB
Presenting Author: Paul McGovern (Venatorx)
Title: Activities of Cefepime-Taniborbactam and Ceftazidime-Avibactam against Cefepime-Resistant Respiratory Gram-Negative Pathogens in a Hollow Fiber Infection Model
Date/Time: October 20, 2022, 12:15 pm – 1:30 pm
Session Title: PK/PD studies
Session Location: Exhibit Hall B/C
Presenting Author: Lindsay Avery (Venatorx)
Title: Development of Cefepime-taniborbactam MIC Antimicrobial Susceptibility Test (AST) for Enterobacterales and Pseudomonas aeruginosa on MicroScan Dried Gram-negative MIC Panels
Date/Time: October 20, 2022, 12:15 pm – 1:30 pm
Session Title: New Antimicrobial Drug Development
Session Location: Exhibit Hall B/C
Presenting Author: Karen Kryston (Beckman Coulter)
Title: Oral Presentation: CERTAIN-1: A Phase 3 Study of Cefepime-Taniborbactam Efficacy and Safety in the Treatment of Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis (AP)
Date/Time: October 20, 2022, 1:45 pm – 3:00 pm
Session Title: Antimicrobial Clinical Trials (Bacterial & Viral)
Session Location: 144 ABC
Presenting Author: Paul McGovern (Venatorx)
Title: In Vitro Activity of Cefepime-Taniborbactam and Comparators Against a Global Collection of Carbapenem-Resistant Enterobacterales and Carbapenem-Resistant Pseudomonas aeruginosa With and Without Carbapenemases
Date/Time: October 22, 2022, 12:15 pm – 1:30pm
Session Title: Antimicrobial Novel Agents
Session Location: Exhibit Hall B/C
Presenting Author: Mark Wise (IHMA)
Title: Antimicrobial Activity of Cefepime-Taniborbactam and Comparators Against Clinical Isolates from ICU and Non-ICU Patients; 2018-2020 Global Surveillance
Date/Time: October 22, 2022, 12:15 pm – 1:30pm
Session Title: Antimicrobial Novel Agents
Session Location: Exhibit Hall B/C
Presenting Author: Meredith Hackel (IHMA)
About Cefepime-Taniborbactam
Cefepime, a fourth-generation cephalosporin, is a widely used beta-lactam (BL) antibiotic with more than two decades of proven safety and clinical utility against susceptible gram-negative and gram-positive bacteria. Taniborbactam is a beta-lactamase inhibitor (BLI) with broad coverage of both serine- and metallo-beta-lactamases. In combination with cefepime, taniborbactam may offer a new treatment option for patients with serious bacterial infections caused by difficult-to-treat drug resistant gram-negative bacteria, most notably carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant or multi-drug resistant Pseudomonas aeruginosa (CRPA/MDR-PA), and other severe or rare infections.
Cefepime-taniborbactam recently completed a Phase 3 study (CERTAIN-1) in adults with complicated urinary tract infections (cUTI), including pyelonephritis. In this study, cefepime-taniborbactam met the primary noninferiority efficacy endpoint at Test-of-Cure visit and furthermore demonstrated statistical superiority to the comparator, meropenem. In addition, cefepime-taniborbactam was well-tolerated with a similar safety profile to meropenem. Based on positive results from the CERTAIN-1 clinical trial, Venatorx expects to submit a New Drug Application to the FDA for cefepime-taniborbactam in the first half of 2023. Cefepime-taniborbactam has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the U.S. Food and Drug Administration (FDA). In October 2022, BARDA awarded a contract of up to $318M for development and procurement of cefepime-taniborbactam for the treatment of melioidosis and multi-drug resistant infections.
About Venatorx Pharmaceuticals
Venatorx is a private, late-stage clinical 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 antibiotic that completed a Phase 3 study in adults with complicated urinary tract infections, including pyelonephritis. Based on positive results from the CERTAIN-1 Phase 3 clinical trial, the Company expects to submit a New Drug Application with the U.S. Food and Drug Administration for cefepime-taniborbactam in the first half of 2023. In October 2022, BARDA awarded a contract of up to $318M for development and procurement of cefepime-taniborbactam for the treatment of melioidosis and multi-drug resistant infections. Venatorx is also developing an oral antibacterial, ceftibuten-ledaborbactam (formerly known as VNRX-7145), for the treatment of cUTI, including pyelonephritis, caused by certain bacteria in adult patients with limited treatment options; this product is nearing completion of Phase 1. For more information about Venatorx and its anti-infectives portfolio, please visit www.venatorx.com.
MEDIA CONTACT:
Jennifer Guinan
Sage Strategic Marketing
jennifer@sagestrat.com
610.410.8111