{"id":18169,"date":"2021-10-21T08:46:11","date_gmt":"2021-10-21T07:46:11","guid":{"rendered":"https:\/\/ppr-antibioresistance.inserm.fr\/?p=18169"},"modified":"2021-12-02T10:39:08","modified_gmt":"2021-12-02T09:39:08","slug":"entasis-therapeutics-announces-positive-topline-results-for-sulbactam-durlobactam-sul-dur-fromphase-3-attack-trial","status":"publish","type":"post","link":"https:\/\/ppr-antibioresistance.inserm.fr\/fr\/informations-et-communications\/actualites\/entasis-therapeutics-announces-positive-topline-results-for-sulbactam-durlobactam-sul-dur-fromphase-3-attack-trial\/","title":{"rendered":"Entasis Therapeutics announces positive topline results for sulbactam-durlobactam (SUL-DUR) from Phase 3 ATTACK trial"},"content":{"rendered":"\n<p>Article published on October 18, 2021 on <a href=\"https:\/\/investors.entasistx.com\/news-releases\/news-release-details\/entasis-therapeutics-announces-positive-topline-results\" target=\"_blank\" rel=\"noreferrer noopener\">Enthasis Therapeutics website<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/investors.entasistx.com\/node\/8076\/pdf\" target=\"_blank\" rel=\"noreferrer noopener\">PDF Version<\/a><\/p>\n\n\n\n<ul><li>SUL-DUR first to achieve statistical non-inferiority in 28-day all-cause mortality in carbapenem-resistant&nbsp;<em>Acinetobacter<\/em>&nbsp;(CRAB) patients<\/li><li>Statistically significant difference in clinical cure at Test of Cure vs. colistin<\/li><li>Favorable safety profile with statistically significant reduction in nephrotoxicity<\/li><li>Targeting NDA submission in mid-2022<\/li><li>Management to host a conference call on&nbsp;October 19, 2021, at&nbsp;8:00am ET<\/li><\/ul>\n\n\n\n<p>WALTHAM, Mass.,&nbsp;Oct. 18, 2021&nbsp;(GLOBE NEWSWIRE) &#8211; <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=yelY0wu90lrgpgucR0LAOHwhAfjBehH2gi0DyGM-u7s6CRD6TNLR_pXvCOm3AdUvW3JTJwXn6hPhoTTNcfZiuy0ilguW4nbqbk7FZSHIEK_6qcezUjI07WBfO-AOTBWw\" rel=\"noreferrer noopener\" target=\"_blank\">Entasis Therapeutics Holdings Inc.<\/a>&nbsp;(Nasdaq:ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, today announced topline results from its ATTACK trial\u2015a global Phase 3 registrational trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by&nbsp;<em>Acinetobacter<\/em>&nbsp;<em>baumannii<\/em>. SUL-DUR met the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant&nbsp;<em>Acinetobacter<\/em>&nbsp;infections (CRABC m-MITT* population in Part A of the study), demonstrating statistical non-inferiority versus colistin. Mortality analyses favored SUL-DUR versus colistin in CRABC m-MITT and all study populations included in the topline results.&nbsp;&nbsp; At Test of Cure, there was a statistically significant difference in clinical response favoring SUL-DUR over colistin. SUL-DUR met the primary safety objective of the study achieving statistically significant reduction in nephrotoxicity.<\/p>\n\n\n\n<p>\u201cATTACK was a landmark clinical trial, the first to successfully evaluate an investigational agent targeting a specific drug-resistant Gram-negative pathogen. SUL-DUR is the first investigational drug to demonstrate efficacy in a 28-day all-cause mortality trial focused on carbapenem-resistant&nbsp;<em>Acinetobacter,<\/em>&nbsp;an \u201cUrgent\u201d threat as designated by the CDC,\u201d said&nbsp;Manos Perros, Chief Executive Officer at Entasis. \u201cThe positive outcome of the ATTACK trial is the culmination of a tremendous effort by our team, and a major milestone for Entasis. We look forward to discussing our data with the regulatory agencies and preparing our first regulatory submission in mid-2022. We are grateful to our partners at Zai Lab and the investigators who made this trial possible, and to the patients and their families for their participation.\u201d<\/p>\n\n\n\n<p>\u201cWe are immensely pleased to see the outcome of this first prospective well-controlled study of severe infections due to CRAB organisms,\u201d said Dr.&nbsp;Samantha Du, Chairperson and CEO at Zai Lab. \u201cCRAB infections are among the worst bacterial infections, and safe and effective treatment options are limited. We look forward to bringing this drug to&nbsp;China, where CRAB infections are still frequently seen in ICUs and result in high morbidity and mortality.\u201d<\/p>\n\n\n\n<p>\u201cPhysicians and patients need new agents for drug-resistant bacteria.&nbsp;<em>Acinetobacter<\/em>&nbsp;infections are some of the most difficult to treat, consume vast healthcare resources and inflict pain and suffering on vulnerable patients. The data from the ATTACK trial are robust and incredibly exciting, demonstrating positive safety and efficacy results, combined with favorable and meaningful clinical cure rates. If approved by regulatory agencies, SUL-DUR will address the urgent need for new treatment options for patients with life-threatening infections caused by&nbsp;<em>Acinetobacter<\/em>&nbsp;species including multidrug-resistant strains,\u201d said&nbsp;Keith S. Kaye, MD, MPH, Chair of the ATTACK trial Data Safety Monitoring Board and Chief,&nbsp;Division of Allergy, Immunology and Infectious Diseases at the&nbsp;Robert Wood Johnson Medical School.<\/p>\n\n\n\n<p>ATTACK enrolled 207 patients at 95 clinical sites in 17 countries. This was a two-part trial with Part A being the randomized, comparative portion (SUL-DUR versus colistin) in patients with documented&nbsp;<em>Acinetobacter<\/em>&nbsp;<em>baumannii<\/em>&nbsp;hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), ventilated pneumonia (VP), or bacteremia and Part B being an open-labeled portion (SUL-DUR only) including&nbsp;ABC&nbsp;infections resistant to or failed colistin or polymyxin B treatment. All patients received imipenem\/cilastatin as background therapy. Approximately 95% of baseline&nbsp;<em>Acinetobacter<\/em>&nbsp;isolates tested were carbapenem resistant.<\/p>\n\n\n\n<ul><li>SUL-DUR met the primary efficacy endpoint of 28-day all-cause mortality compared to colistin in the CRABC m-MITT population (n=125) of Part&nbsp;A. SUL-DUR&nbsp;mortality was 19.0% (12\/63) compared to 32.3% (20\/62) in the colistin arm (treatment difference of -13.2%; 95% CI: -30.0, 3.5)<\/li><li>Similar trends were observed in 28-day and 14-day all-cause mortality favoring SUL-DUR across all study populations evaluated to date<\/li><li>A statistically significant difference in clinical cure at Test of Cure (TOC) was observed with 61.9% in SUL-DUR arm compared to 40.3% in the colistin arm (95% CI: 2.9, 40.3)<\/li><li>In Part B, the 28-day all-cause mortality was 17.9% (5\/28) and consistent with that observed in Part A<\/li><\/ul>\n\n\n\n<p>Safety analyses were conducted in a total of 205 patients with at least one dose in Part A and Part B.<\/p>\n\n\n\n<ul><li>SUL-DUR met the primary safety objective with a statistically significant reduction in nephrotoxicity as measured by the RIFLE** classification. SUL-DUR nephrotoxicity was 13.2% (12\/91) versus 37.6% (32\/85) in the colistin arm (p = 0. 0002)<\/li><li>Overall adverse events (AEs) in the safety population were comparable between treatment groups with 87.9% (80\/91) in the SUL-DUR arm versus 94.2% (81\/86) in the colistin arm in Part A, 89.3% (25\/28) in Part B<\/li><li>Drug related AEs were 12.1% (11\/91) with SUL-DUR compared to 30.2% (26\/86) with colistin in Part A, 10.7% (3\/28) in Part B<\/li><\/ul>\n\n\n\n<p><em>*Carbapenem-resistant Acinetobacter baumannii-calcoaceticus Complex Microbiologically Modified Intent-to-Treat Population<\/em><br><em>**Risk-Injury-Failure-Loss-End-stage renal disease (measured by creatinine level or glomerular filtration rate)<\/em><\/p>\n\n\n\n<p><strong>Conference Call<\/strong><br>Investors and the public are invited to listen to a live audio webcast of the conference call, scheduled for&nbsp;October 19, 2021, at&nbsp;8:00am ET, which may be accessed five minutes prior to the start of the call by dialing 877-407-4018 (U.S.) or 201-689-8471 (international) Conference ID 13724038 or through the link&nbsp;<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=yelY0wu90lrgpgucR0LAOHwhAfjBehH2gi0DyGM-u7vaujI-jmDvtliYtI-fpfyCPoeV7teaGR0ktIeg_wUZ-kxR3NjN9Pzeu8BP8PilyzfV0hH1dFPqdMQk_e1Abi97vHfCSen1TNvbDV66kPwJmQGjmMAH-oN3E1VX3aNjp3n2vZZENwV_D0LgIHqzgT94\" rel=\"noreferrer noopener\" target=\"_blank\">Entasis Therapeutics Holdings Inc.&nbsp;Data Call.<\/a>&nbsp;A replay of the call will be available from the Entasis website at&nbsp;<a href=\"http:\/\/www.entasistx.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.entasistx.com<\/a>&nbsp;following the call.<\/p>\n\n\n\n<p><strong>About sulbactam-durlobactam (SUL-DUR)<br><\/strong>SUL-DUR is an intravenous, or IV, investigational drug that is a combination of sulbactam, an IV \u03b2-lactam antibiotic, and durlobactam, a novel broad-spectrum IV \u03b2-lactamase inhibitor, or BLI, being developed for the treatment of infections caused by&nbsp;<em>Acinetobacter baumannii<\/em>, including carbapenem-resistant strains. The global Phase&nbsp;3 registrational ATTACK trial was initiated in&nbsp;April 2019&nbsp;with positive Phase 3 topline data announced in&nbsp;October 2021. NDA submission is planned for mid-2022.<\/p>\n\n\n\n<p><strong>About&nbsp;<\/strong><strong><em>Acinetobacter<br><\/em><\/strong><em>Acinetobacter<\/em>&nbsp;is a Gram-negative, opportunistic human pathogen that predominantly infects critically ill patients often resulting in severe pneumonia and bloodstream infections; but it can also infect other body sites such as the urinary tract and the skin.&nbsp;<em>Acinetobacter<\/em>&nbsp;is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance at rates not previously seen in other bacteria. Based on current carbapenem resistance rates, we estimate there are in excess of 300,000 hospital-treated carbapenem-resistant&nbsp;<em>Acinetobacter<\/em>&nbsp;infections annually across&nbsp;the United States,&nbsp;Europe, the&nbsp;Middle East&nbsp;and&nbsp;China&nbsp;for which significant morbidity and mortality exists due to limited treatment options.<\/p>\n\n\n\n<p><strong>About&nbsp;Entasis Therapeutics Holdings Inc.<\/strong><br>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\u2019 pathogen-targeted design platform has produced a pipeline of product candidates, including SUL-DUR (targeting&nbsp;<em>Acinetobacter baumannii<\/em>&nbsp;infections), zoliflodacin (targeting&nbsp;<em>Neisseria gonorrhoeae<\/em>&nbsp;infections), ETX0282CPDP (targeting Enterobacterales infections) and ETX0462 (targeting Gram-negative infections including&nbsp;<em>Pseudomonas<\/em>). For more information, visit&nbsp;<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=3YpcTXLi9Ls7ro2Xo8HIDBvFiEc_AtOdQytXjSMJ5h1KR0Vnc73tFOgUFjRW6yFkpil_eSPYz8wa2usL06qyWg==\" rel=\"noreferrer noopener\" target=\"_blank\">www.entasistx.com<\/a>.<\/p>\n\n\n\n<p>Company Contact Investor Contact<br>Kyle Dow Bruce Mackle<br>Entasis Therapeutics LifeSci Advisors<br>(781) 810-0114 (929) 469-3859<br><a href=\"mailto:kyle.dow@entasistx.com\" target=\"_blank\" rel=\"noreferrer noopener\">kyle.dow@entasistx.com<\/a>,  <a href=\"mailto:bmackle@lifesciadvisors.com\" target=\"_blank\" rel=\"noreferrer noopener\">bmackle@lifesciadvisors.com<\/a><\/p>\n\n\n\n<p>Media Contact<br>Brett Whelan<br>LifeSci Communications<br>(215) 315 3143<br><a href=\"mailto:bwhelan@lifescicomms.com\" target=\"_blank\" rel=\"noreferrer noopener\">bwhelan@lifescicomms.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Article published on October 18, 2021 on Enthasis Therapeutics website PDF Version SUL-DUR first to achieve statistical non-inferiority in 28-day all-cause mortality in carbapenem-resistant&nbsp;Acinetobacter&nbsp;(CRAB) patients Statistically significant difference in clinical cure at Test of Cure vs. colistin Favorable safety profile with statistically significant reduction in nephrotoxicity Targeting NDA submission in mid-2022 Management to host a [&hellip;]<\/p>\n","protected":false},"author":139,"featured_media":18175,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[31],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.8 - 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