Entasis Highlights Positive Phase I Data For ETX2514 At IDWeek 2017, Announces Plans To Advance Combination With Sulbactam (ETX2514SUL) Into Phase II Trials
Published: Oct 09, 2017
WALTHAM, Mass.--(BUSINESS WIRE)--Entasis Therapeutics, a leader in the discovery and development of breakthrough anti-infective products, today announced the results of its four-part, Phase 1 study in healthy subjects of ETX2514, a clinical-stage compound under development in combination with sulbactam for the treatment of carbapenem-resistant Acinetobacter baumannii infections. The results were presented at the IDWeek 2017 conference in San Diego, California on Saturday, October 7. Data presented at the conference included results from the single-ascending dose, multiple-ascending dose, and drug-drug interaction parts of the study.
“The results from this Phase 1 study demonstrate that ETX2514 is generally safe and well tolerated over the dose range studied and could be co-administered with sulbactam and/or imipenem/cilastatin,” said Robin Isaacs, M.D., Chief Medical Officer of Entasis. “We are very pleased with these Phase 1 findings and plan to advance ETX2514 into next-stage clinical trials which will include evaluation against multidrug-resistant infections with high unmet medical need.”
In a poster titled, “Safety and Pharmacokinetics (PK) in Humans of Intravenous ETX2514, a ß-lactamase Inhibitor (BLI) which Broadly Inhibits Ambler Class A, C, and D ß-lactamases,” Entasis collaborators demonstrated that ETX2514, either alone or in combination with sulbactam (SUL) and/or imipenem/cilastatin (IMP), was generally well tolerated. In addition, the general safety profile of ETX2514 was unchanged when co-administered, as a single dose, with SUL, with IMP, and with SUL and IMP. The Phase 1, randomized, placebo-controlled trial was conducted in 124 healthy subjects. The most commonly reported adverse events included headaches, catheter site inflammation, mild drowsiness and nausea. Results of this study in conjunction with preclinical data previously presented support further evaluation of ETX2514SUL as a treatment option for A. baumannii infections.
“The World Health Organization (WHO) recently announced strong concerns over the lack of antibiotics to tackle a number of pathogens that have developed high-resistance to most currently available antibiotics,” said Manos Perros, PhD, CEO of Entasis. “Acinetobacter baumannii infections are frequently multi-drug resistant, resulting in high mortality and morbidity in some of the most vulnerable patients. ETX2514SUL has the potential to provide a much-needed alternative to failing treatment options. The promising preclinical profile of ETX2514, combined with the findings from the Phase 1 study make a compelling case for progressing ETX2514SUL into Phase 2 testing.”
About Acinetobacter baumannii
Acinetobacter baumannii is a hospital-associated Gram-negative pathogen that causes a wide range of diseases including respiratory tract, bloodstream, urinary tract and wound infections. A rise in infections due to multidrug-resistant (MDR) A. baumannii strains has been reported over the last 2 decades, limiting treatment options to only a few drugs. However, a global surge in carbapenem resistance has been observed recently. In the U.S., approximately 63% of A. baumannii bacteria are considered multi-drug resistant. A. baumannii infections result in mortality rates approaching 50% for pneumonia and bacteremia. For this reason, the Infectious Diseases Society of America has included A. baumannii among the six most-threatening antimicrobial-resistant pathogens responsible for high morbidity and mortality in patients. The CDC classified A. baumannii as a serious public health threat, and the World Health Organization ranked A. baumannii infections as “critical” on the WHO Priority Pathogens List for R&D of New Antibiotics.
ETX2514 is a potent and broad-spectrum inhibitor of class A, C, and D beta-lactamases. ETX2514 restores the in vitro activity of multiple beta-lactams against Gram-negative, multi-drug resistant (MDR) pathogens. Entasis Therapeutics is initially developing ETX2514SUL, the combination of ETX2514 and sulbactam, for the treatment of severe A. baumannii infections. Sulbactam is a generic beta-lactam which has intrinsic activity against A. baumannii but suffers from widespread beta-lactamase-mediated resistance. In preclinical studies, ETX2514 restored sulbactam antibacterial activity against A. baumannii. ETX2514 has completed single- and multi-ascending dose Phase 1 trials. The U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation and Fast Track status to ETX2514SUL for the treatment of hospital-acquired and ventilator-acquired bacterial pneumonia and bloodstream infections due to A. baumannii.
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. Entasis’ anti-infective discovery platform has produced a pipeline of meaningfully differentiated programs which target serious bacterial infections, including ETX2514SUL (targeting Acinetobacter baumannii infections), ETX0282CPDP (targeting Enterobacteriaceae infections), Non-Beta-lactam PBP inhibitor (targeting Gram-negative infections), and zoliflodacin (targeting Neisseria gonorrhoeae). www.entasistx.com
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