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Trial to evaluate safety, efficacy of ZTI-01 against cUTI

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Zavante Therapeutics has announced the initiation of a clinical trial assessing the safety and efficacy of fosfomycin for injection in patients with complicated urinary tract infections, acute pyelonephritis and other serious infections caused by multidrug-resistant pathogens, according to a press release.

Researchers from the ZEUS trial, a randomized, active-controlled, double blind study, will enroll approximately 460 patients hospitalized at 110 medical facilities. The study is expected to be completed by the second half of 2017, according to the release.

“The lack of available and effective antibiotics for these life-threatening multidrug-resistant pathogens has created an important unmet medical need that is widely acknowledged by national medical agencies and societies,” George Drusano, MD, professor of medicine and director of the Institute for Therapeutic Innovation, College of Medicine at the University of Florida, said in the release.

Fosfomycin for injection, or ZTI-01, is an injectable epoxide antibiotic that previously has demonstrated activity against a wide variety of gram-negative and gram-positive pathogens, including MDR bacterial strains, the release said. ZTI-01 was granted qualified infectious disease product (QIDP) designation for complicated urinary tract infections (cUTI) by the FDA in September 2014. The QIDP was expanded in December 2015 to include complicated intra-abdominal infections, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia, and acute bacterial skin and skin structure infections. The FDA granted fast-track designations for all four QIDP designations, making ZTI-01 available for the development of new antibiotics, including priority review and 5 years of market exclusivity under the Generating Antibiotic Incentives Now Act.

Ted Schroeder, founder, president and CEO of Zavante, anticipates filing a new drug application for ZTI-01 with the FDA in the second half of 2017, the release said.

“An antibiotic with a unique mechanism of action like ZTI-01 would be an important addition to our antibacterial armamentarium when treating seriously ill patients in the hospital,” Drusano said.

Disclosure: Schroeder is the founder, president and CEO of Zavante. Infectious Disease News was unable to confirm other relevant financial disclosures at the time of publication.