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Entasis starts phase 3 trial for A. baumannii combination
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Entasis Therapeutics announced the start of a global phase 3 clinical trial to evaluate a novel antibiotic for the treatment of patients with pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii, with the hope of filing a new drug application with the FDA once the trial is complete.
The trial, titled Acinetobacter Treatment Trial Against Colistin (ATTACK), will evaluate ETX2514SUL, a fixed-dose combination of the broad-spectrum beta-lactamase inhibitor ETX2514 with sulbactam.
“With ATTACK, we are taking potentially the final step in the clinical development of ETX2514SUL, a pathogen-targeted combination against Acinetobacter, which has the potential to safely and effectively restore the health of seriously ill patients,” Manos Perros, PhD, CEO of Entasis Therapeutics, told Infectious Disease News.
“Increasing rates of antibiotic resistance and limited treatment options have led to the growing significance of Acinetobacter as a hospital-acquired infection, leading to high mortality and morbidity rates in already vulnerable patients. ATTACK is the first global phase 3 trial for an agent specifically targeting drug-resistant Acinetobacter, and a positive outcome could provide a much-needed safe and effective treatment.”
A 2013 CDC report outlined multidrug-resistant Acinetobacter as one of the top antibiotic resistance threats in the United States. According to the report, there are approximately 7,000 multidrug-resistant Acinetobacter infections in the U.S. each year, causing around 500 deaths. Infections with carbapenem-resistant A. baumannii have been associated with death rates of up to 52%.
Outbreaks resulting from A. baumannii occur most commonly in ICUs and health care settings with seriously ill patients, according to Entasis. The ATTACK study is looking to address the significant unmet medical need of growing resistance to carbapenems in the last decade, the company said.
Perros noted that although most patients can be successfully treated with broad-spectrum antibiotics, a growing number are becoming infected with organisms that are resistant to older antibiotics.
“To help these patients, we are taking a ‘precision medicine’ approach, inventing and developing agents designed to overcome existing resistance mechanisms,” he said. “We want to see those new agents used for the right patients at the right time, in order to preserve their efficacy according to best stewardship practices, but without compromising the physician’s ability to timely and successfully treat their patients. If successful, ETX2514SUL will be the first such agent to reach the market and help patients suffering from Acinetobacter infections.”
The phase 3 trial will enroll 300 participants from 18 countries, Entasis said. Since the announcement of the trial in April, Entasis has been working to open additional sites for enrollment and obtain regulatory approval for clinical trial initiation in additional territories, according to Perros. – by Joe Gramigna and Bruce Thiel
Reference:
CDC. Antibiotic resistance threats in the United States, 2013. https://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf. Accessed May 30, 2019.
Disclosures: Isaacs and Perros are employees of Entasis Therapeutics.