Entasis Therapeutics, a company focused on the discovery and development of breakthrough anti-infective products, today announced initiation of a Phase 1 clinical study of ETX2514. The study will evaluate the safety, tolerability and pharmacokinetics of ETX2514 in healthy volunteers. ETX2514, Entasis’ next-generation beta-lactamase inhibitor, 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 targeting serious A. baumannii infections.
“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,” said Robin Isaacs, M.D., Chief Medical Officer of Entasis Therapeutics. “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."
Manos Perros, Ph.D., President and Chief Executive Officer of Entasis 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.”
About the Phase I Clinical Trial
The Phase I study is a double-blind, randomized, placebo-controlled study of ETX2514 in healthy subjects. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of ETX2514 alone and in combination with sulbactam. The trial is being conducted in Australia and is expected to be completed in the first half of 2017. More information about this clinical trial is available at the Australian New Zealand Clinical Trials Registry (Trial ID: ACTRN12616000995471).
ETX2514 is a broad and potent inhibitor of class A, C, and D beta-lactamases. A. baumannii is a Gram-negative bacterium that causes severe infections which are associated with high mortality. A. baumannii infections are frequently multi-drug resistant and there is an urgent need to identify new safe and effective agents to treat affected patients. Sulbactam is a beta-lactam which has intrinsic activity against A. baumannii, but beta-lactamase-mediated resistance to sulbactam is now widespread. In preclinical studies, ETX2514 restores sulbactam’s antimicrobial activity. Entasis Therapeutics is developing ETX2514SUL, the combination of ETX2514 and sulbactam, for the treatment of severe A. baumannii infections.
About Entasis Therapeutics Inc.
Entasis Therapeutics is developing a portfolio of innovative cures for serious drug-resistant bacterial infections, a global health crisis affecting the lives of millions of patients. Our deep pipeline of fundamentally innovative clinical and preclinical anti-infective programs is designed to revolutionize the way physicians treat serious bacterial diseases. www.entasistx.com
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Last updated on: 26/10/2016
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