The companies announced a licensing agreement on cefepime-taniborbactam.
Cefepime-taniborbactam is a late-stage, investigational antibiotic that has been studied for complicated urinary tract infections (cUTI), and was developed by Malvern, PA,-based Venatorx Pharmaceuticals. In its phase 3 study, CERTAIN 1, the company’s clinical results demonstrated it had achieved its primary efficacy endpoint and showed superiority to meropenem as a treatment for hospitalized adult patients with cUTI, including acute pyelonephritis.
With its successful findings, Venatorx applied for submission of a New Drug Application (NDA) with the FDA. The company was granted a PDUFA target action date set for February 22, 2024.
Ahead of its potential approval, the company announced this week it was partnering with Parsippany, NJ-based Melinta Therapeutics in a licensing agreement to commercialize cefepime-taniborbactam.1
“This partnership will allow Venatorx to continue advancing all of the R&D and regulatory elements of its infectious diseases portfolio including its US government contractual commitments," Venatorx CEO Christopher J. Burns, PhD, said in a statement.1
What the Data Demonstrated
CERTAIN (Cefepime Rescue with Taniborbactam in cUTI) was a global, randomized, double-blind, active-controlled non-inferiority phase 3 study evaluating the efficacy, safety, and tolerability of cefepime-taniborbactam compared to meropenem in adults with cUTI, including acute pyelonephritis.
The study enrolled 661 adult patients who were randomized 2:1 to receive cefepime-taniborbactam 2.5g q8h or meropenem 1g q8h for 7 days (up to 14 days for patients with bacteremia).
The primary efficacy endpoint evaluated the composite clinical and microbiologic response (i.e., bacterial eradication) at the Test of Cure (TOC) visit (Day 19-23) in the microbiological intent-to-treat (microITT) population as specified by FDA and European Medicines Agency guidance.
Cefepime-taniborbactam met the primary efficacy endpoint of statistical noninferiority (NI) to meropenem in the microITT population at TOC with composite microbiologic and clinical success occurring in 70.0% of cefepime-taniborbactam treated patients and 58.0% of meropenem treated patients (treatment difference 11.9; 95% confidence interval (CI), 2.4, 21.6).
A prespecified superiority test following confirmation of NI demonstrated the statistical superiority of cefepime-taniborbactam for the composite endpoint at TOC. The superiority of cefepime-taniborbactam was sustained for the composite microbiologic and clinical response at the Late-Follow-Up (Day 28-35) visit.
Rates of treatment-emergent adverse events (TEAEs) were 35.5% for cefepime-taniborbactam and 29.0% for meropenem. Serious TEAEs occurred in 2.0% and 1.8% of cefepime-taniborbactam and meropenem treated patients, respectively.
Treatment discontinuations due to TEAEs were infrequent, occurring in 3.0% of cefepime-taniborbactam patients and 0.9% of meropenem treated patients.
From Humble Beginnings
Burns says he cofounded the company with 2 other longtime friends, Daniel Pevear, PhD, senior vice president, Biology and Grants Development, and Luigi Xerri, PhD, senior strategic advisor and head of Scientific Affairs, Venatorx at a well-known, corporate bakery and restaurant. The 3 pharmaceutical veterans laid the groundwork for the company there, which was started in 2010, and is headquartered in suburban Philadelphia. The company name comes from the Latin word venator, which means hunter, and rx is the medical symbol for drugs.
Typically, it takes 10 to 15 years from drug development to FDA approval for antibiotics. Burns understands the long road of navigating this unique path beginning in the laboratory developing a unique chemical compound and going through the process of getting funding and approvals and going through clinical trials. It takes wearing both a white lab coat as well as a business suit to achieve such lofty goals. And even if you do get your therapy approved, it has to gain traction in the market, which can be difficult.
“When one tries to commercialize a new antibiotic...it's very difficult to stay alive during the first 2, 3, even 4 years, while you're slowly establishing a market. And that is what has made the small companies suffer in the space," Burns said. He sees the value of the prospective Pasteur Act as a bridge to helping companies with their antibiotics getting through those early years.
Venatorx is also studying cefepime-taniborbactam for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults. “We are planning to imminently begin enrollment of what's often euphemized, as a half-of-that study, of a hospital acquired bacterial pneumonia study,” Burns said.
Contagion spoke to Burns recently and he offered further insights on cefepime-taniborbactam, his thoughts on the Pasteur Act, and more information on his company’s pipeline.
1. Melinta Therapeutics and Venatorx Pharmaceuticals Announce Licensing Agreement to Commercialize Cefepime-Taniborbactam in the U.S. Venatorx press release. November 9, 2023.https://www.venatorx.com/press-releases/melinta-therapeutics-and-venatorx-pharmaceuticals-announce-licensing-agreement-to-commercialize-cefepime-taniborbactam-in-the-u-s/