Entasis Therapeutics Initiates Global Phase 3 Pivotal Trial of ETX2514SUL for Patients with Carbapenem-Resistant Acinetobacter Infections
A. baumannii is a Gram-negative bacterium that causes severe infections and is associated with high mortality, increasing rates of antibiotic resistance and growing significance as a hospital-acquired infection due to limited treatment options. Outbreaks of A. baumannii typically occur in intensive care units and healthcare settings with seriously ill patients, and can either cause or contribute to death. Resistance to carbapenems, a class of antibiotics commonly used for the treatment of severe bacterial infections, has grown substantially amongst Acinetobacter in the last decade, resulting in a significant unmet medical need.
“There are currently very limited antibiotic choices for the treatment of multidrug-resistant A. baumannii infections, and mortality rates approach 50%,” said
ATTACK is a global, two-part Phase 3 clinical trial that will enroll a total of 300 patients from 18 countries. The Company believes this single Phase 3 trial could be sufficient to support the filing of a new drug application with regulatory authorities in both the U.S. and
"We are excited to initiate our global ATTACK clinical trial with the ultimate goal of obtaining regulatory approval in the U.S. and other countries,” said Manos Perros, Chief Executive Officer,
The initiation of ATTACK follows the 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) the timing of the availability of data; (iii) design of the Phase 3 clinical trial of ETX2514SUL, including plans to incorporate BIOFIRE Instruments and Pneumonia Panels into this trial and their ability to optimize and accelerate patient enrollment; (iv) the success of the Phase 3 clinical trial of ETX2514SUL; (v) the sufficiency of the single trial to support the filing of an NDA with the
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Source: Entasis Therapeutics Holdings Inc.