Entasis Therapeutics Receives Positive Feedback from FDA End-of-Phase 2 Meeting for ETX2514SUL; Signs Rapid Diagnostic Agreement with bioMérieux
Further, Entasis announced an agreement with bioMérieux, a world leader in the field of in vitro diagnostics, pursuant to which Entasis will incorporate BIOFIRE® FILMARRAY® Instruments and BIOFIRE® FILMARRAY® Pneumonia Panels into its global Phase 3 trial for ETX2514SUL for enrollment optimization. The BIOFIRE System is an
"We are extremely pleased with the outcome of our End-of-Phase 2 meeting with the
ETX2514 is a novel, broad-spectrum inhibitor of class A, C, and D β-lactamases. ETX2514 restores the in vitro activity of multiple β-lactams against Gram-negative, multidrug-resistant (MDR) pathogens.
Entasis is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ targeted-design platform has produced a pipeline of product candidates, including ETX2514SUL (targeting A. baumannii infections), zoliflodacin (targeting Neisseria gonorrhoeae), and ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is also using its platform to develop a novel class of antibiotics, non-β-lactam inhibitors of the penicillin-binding proteins (NBPs) (targeting Gram-negative infections). For more information, visit www.entasistx.com.
Entasis Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Entasis’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements about (i) the timing of the initiation, progress and scope of the Phase 3 clinical trial of ETX2514SUL; (ii) design of the Phase 3 clinical trial of ETX2514SUL, including plans to incorporate BIOFIRE Instruments and Pneumonia Panels into this trial; and (iii) the success of the Phase 3 clinical trial of ETX2514SUL. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during non-clinical or clinical studies, clinical site activation rates or clinical trial enrollment rates that are lower than expected and changes in expected or existing competition. Except as required by law, Entasis assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
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Source: Entasis Therapeutics Holdings Inc.