Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced the initiation of a pivotal Phase 3 trial of CXA-201 in patients with complicated urinary tract infections (cUTI). CXA-201 is being developed as a first-line intravenous therapy for the treatment of serious Gram-negative bacterial infections in the hospital, including those caused by multi-drug resistant Pseudomonas aeruginosa.
This trial is the first of two planned multicenter, global, double-blind, randomized Phase 3 studies to compare the safety and efficacy of CXA-201 relative to the comparator, levofloxacin, in patients with cUTI. The primary objective of the study is to establish non-inferiority of CXA-201 to the comparator with respect to the proportion of patients in the modified microbiological intent to treat (mMITT) population who achieve both microbiological eradication and clinical cure at the test-of-cure (TOC) visit 5-9 days after the last dose of the study drug is administered. Cubist expects to enroll approximately 775 patients in this trial, which will also assess the safety of CXA-201 and investigate other pre-specified secondary endpoints.
Later this year, the company plans on initiating another pivotal global Phase 3 trial of CXA-201 in patients with complicated intra-abdominal infections (cIAI).
Brad Spellberg, MD, Associate Professor of Medicine at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center said, "The start of the phase 3 trial for CXA-201 is an important milestone for the infectious diseases community. CXA-201 is 'the tip of the spear' among several potential future treatments for resistant Gram negative infections that are in development in industry. CXA-201 is the first of them to enter phase 3 trials."
Cubist's Chief Medical Officer Santosh Vetticaden, PhD, MD, said, "The start of this pivotal phase 3 trial represents a major milestone in the development of CXA-201, and we are extremely pleased to be making such a significant advance in this program that offers promise for the treatment of certain Gram-negative infections."
Source: Cubist Pharmaceuticals, Inc.