Entasis Theraputics has initiated its Phase 1 clinical study of ETX2514 to evaluate the safety, tolerability and pharmacokinetics of ETX2514 in healthy volunteers.
Entasis’ next-generation beta-lactamase inhibitor, ETX2514 with a novel mode-of-action and expanded spectrum of antimicrobial activity is initially being developed in combination with sulbactam, a beta-lactam with activity against Acinetobacter baumannii.
The combination, ETX2514SUL, is a novel, potent antibiotic intended to target serious A. baumannii infections.
Entasis Therapeutics chief medical officer Robin Isaacs said: “We are very enthusiastic about the initiation of this clinical study, which will begin to establish the safety, tolerability and administration profile of ETX2514 in the clinic.
“This study builds on our extensive research in preclinical infection models, which indicate that the administration of sulbactam in combination with ETX2514 holds great promise against drug-resistant A. baumannii infections.”
Entasis president and CEO Manos Perros said: “We strongly believe that ETX2514SUL could address a significant and increasing unmet medical need in patients with severe A. baumannii infections that are frequently resistant to modern antibiotics.
"The successful launch of this clinical study is a significant milestone for Entasis and represents a meaningful step forward in bringing ETX2514SUL to the patients who need it.”
The Phase I trial is a double-blind, randomised, placebo-controlled study of ETX2514 in healthy subjects.
It is intended to evaluate the safety, tolerability, and pharmacokinetics of ETX2514 alone and in combination with sulbactam.
The study is being conducted in Australia and is expected to be completed in the first half of 2017.
Image: An SEM depicting clusters of A. baumannii bacteria. Photo: courtesy of Janice Carr.