100917_Entasis IDWeek ETX2514 Abstract PR FINALFDA grants Qualified Infectious Disease Product (QIDP) and Fast Track designation to ETX2514SUL, the combination of ETX2514 with sulbactam
WALTHAM, Mass. — September 28, 2017 — Entasis Therapeutics, a leader in the discovery and development of breakthrough anti-infective products, today announced the presentation of data on ETX2514 at IDWeek 2017, which is being held from October 4-8 in San Diego, California. ETX2514 is a novel, broad-spectrum beta-lactamase inhibitor (BLI) with activity against class A, C and D beta-lactamases. The posters will highlight Phase 1 clinical data on ETX2514 as well as efficacy against Acinetobacter baumannii in combination with sulbactam in preclinical testing.
Entasis also announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designation to sulbactam-ETX2514 for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and bloodstream infections (BSI) due to A. baumannii. Created under the Generating Antibiotics Incentives Now (GAIN) Act of 2012, QIDP designation provides significant incentives for the development of innovative antimicrobial agents like ETX2514SUL, including the potential for priority review by the FDA and a five-year extension of marketing exclusivity under the Hatch-Waxman Act. Fast Track status is a process designed to facilitate and accelerate interactions with the FDA on issues related to study design, safety data, the use of biomarkers and other critical issues in the development and regulatory review of drugs.
Details of the IDWeek 2017 presentations are as follows:
Title: Safety and Pharmacokinetics (PK) in Humans of Intravenous ETX2514, a β-lactamase Inhibitor (BLI) which Broadly Inhibits Ambler Class A, C, and D β-lactamases.
Poster Number: 1836
Session: Clinical Study with New Antibiotics and Antifungals
Day/Time: Saturday, October 7, 2017, 12:30 PM-2:00 PM, Poster Hall CD
Overview: Outlines Entasis’ Phase 1 results for varying doses of ETX2514, either alone or in combination with sulbactam and/or imipenem/cilastatin.
Title: The Novel β-Lactamase Inhibitor, ETX-2514, in Combination with Sulbactam Effectively Inhibits Acinetobacter baumannii
Poster Number: 1204
Session: Expanded Spectrum – New Antimicrobial Susceptibility Testing
Day/Time: Friday, October 6, 2017, 12:30 PM-2:00 PM, Room: Poster Hall CD
Overview: A poster from researchers at Case Western Reserve University, Cleveland, Ohio that examines the activity of ETX2514 against A. baumannii.
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 A. baumannii infections. A. baumannii is a Gram-negative bacterium that causes severe infections which are associated with high mortality rates. 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 generic beta-lactam which has intrinsic activity against A. baumannii but suffers from widespread beta-lactamase-mediated resistance. In preclinical studies, ETX2514 restores sulbactam antibacterial activity against A. baumannii. ETX2514 recently 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), and zoliflodacin (targeting Neisseria gonorrhoeae). www.entasistx.com
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