Entasis Therapeutics, a Wholly Owned Subsidiary of Innoviva, Presents Efficacy and Safety Data from Landmark Phase 3 ATTACK Trial at IDWEEK 2022
2022-10-20
并购合作临床3期临床结果
WALTHAM, Mass., Oct. 19, 2022 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc., a late-stage clinical biopharmaceutical company focused on the discovery and development of novel antibacterial products, and wholly owned subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced the presentation of additional safety and efficacy data from the Company’s pivotal Phase 3 ATTACK trial. The study results will be presented at IDWeek 2022, the annual meeting of the Infectious Disease Society of America held October 19-23, 2022 in Washington, D.C.
"The data we are presenting at IDWeek 2022 reinforce the positive safety and efficacy findings we previously described from our topline data analysis,” said David Altarac, MD, Chief Medical Officer of Entasis. “These data underscore the potential impact of SUL-DUR, if approved, as a treatment option for patients with drug-resistant Acinetobacter infections, where no current standard of care exists."
On Thursday, October 20 there will be two oral presentations and three poster presentations followed by an oral presentation Saturday, October 22nd.
Oral Presentations
An oral presentation entitled Microbiologic and clinical outcome concordance in the global phase 3 ATTACK trial: sulbactam-durlobactam (SUL-DUR) versus colistin therapy in patients with Acinetobacter baumannii-calcoaceticus complex (ABC) infections will be presented October 20 1:45-3pm ET by David Altarac, MD Chief Medical Officer of Entasis. Results of the study showed non-inferiority in 28-day all-cause mortality and overall trends favoring SUL-DUR, such as higher clinical cure rate at Test of Cure and greater microbiologic favorable response at Test of Cure. The study showed that treatment with SUL-DUR demonstrated lower mortality, higher clinical cure rates, and greater microbiologically favorable outcomes than colistin in patients with carbapenem-resistant ABC infections. Concordance between clinical and microbiological outcomes was observed.
The second oral presentation entitled Efficacy of sulbactam-durlobactam (SUL-DUR) versus colistin in patients with extensively drug-resistant (XDR) and pan-drug resistant (PDR) Acinetobacter baumannii-calcoaceticus complex (ABC) infections, will be presented October 20 1:45-3pm ET by Alita Miller, PhD, interim Chief Scientific Officer for Entasis. Results showed that ABC isolates from patients in ATTACK were highly antibiotic-resistant, but >95% susceptible to SUL-DUR. Treatment with SUL-DUR demonstrated lower mortality, higher clinical cure rates, and greater microbiologically favorable outcomes than colistin in patients with XDR or PDR ABC infections. In global surveillance studies, 100% of PDR ABC isolates were susceptible to SUL-DUR.
The third oral presentation titled Population pharmacokinetic (PPK), pharmacokinetic/pharmacodynamic attainment (PTA), and clinical pharmacokinetic/pharmacodynamic (PK/PD) analyses for sulbactam-durlobactam (SUL-DUR) to support dose selection for the treatment of Acinetobacter baumannii calcoaceticus complex (ABC) infections will be presented October 22 1:45-3pm ET in the late breaking session by Sujata Bhavnani, PharmD, M.S., FIDSA of the Institute for Clinical Pharmacodynamics. This study evaluated PPK in 373 subjects, including 110 patients who received SUL-DUR and underwent PK sampling in the pivotal Phase 3 ATTACK trial. Investigators concluded that simulated plasma and ELF exposures yielded >90% probability of target attainment, which when combined with the favorable efficacy and safety findings from ATTACK, support a dose of 1.0 g sulbactam/1.0 g durlobactam via a 3-hour infusion, every 6 hours in patients with normal renal function and renal function-based dose adjustments.
Poster Presentations:
In addition to the oral presentations, three poster presentations highlighted additional SUL-DUR and ATTACK trial details and results.
Title: Sulbactam-durlobactam (SUL-DUR) versus colistin therapy in patients with Acinetobacter baumannii-calcoaceticus complex (ABC) infections: A detailed safety review from the pivotal phase 3, global, randomized, active-controlled trial (ATTACK)
Summary: In the ATTACK trial, SUL-DUR achieved the primary safety objective of significantly reduced incidence of nephrotoxicity compared with colistin, was generally well tolerated in severely ill patients, and demonstrated a favorable safety profile with no new safety signals identified.
Presenter: Drew Lewis, MD, MTM&H, FACP
Poster #: 675
Date and time: Thursday, October 20, 2022, 12:15pm-1:30pm ET
Title: Efficacy and safety of sulbactam-durlobactam (SUL-DUR) are consistent across regions in the global ATTACK phase 3 trial in the treatment of carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC) infections
Presenter: Khurram Rana, PharmD
Poster #: 225
Date and time: Thursday, October 20, 2022, 12:15pm-1:30pm ET
Title: Characterization of colistin-resistant (COL-R) Acinetobacter baumannii-calcoaceticus complex (ABC) isolates from a recent global phase 3 trial (ATTACK)
Summary: A large number of ABC infections in ATTACK were colistin-resistant (COL-R); most of which were in Europe. SUL-DUR maintained in vitro activity against colistin-resistant, XDR and PDR subsets of ABC isolates from ATTACK. Patients with COL-R infections treated with SUL-DUR had favorable clinical and microbiological outcomes.
Presenter: Sarah McLeod, PhD
Poster #: 518
Date and time: Thursday, October 20, 2022, 12:15pm-1:30pm ET
All EntasisIDWeek 2022 presentations will be made available on the Entasis website https://www.entasistx.com/our-science/presentations-by-event.
About Sulbactam-Durlobactam (SUL-DUR)
SUL-DUR is an intravenous, or IV, investigational drug that is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a novel broad-spectrum IV β-lactamase inhibitor, or BLI, being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including carbapenem-resistant strains. Top-line results were announced in October 2021.
SUL-DUR Expanded Access Program
Entasis Therapeutics will consider providing a requesting physician with pre-approval access to SUL-DUR, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. More information about its Expanded Access Program and polices is available here.
Entasisis a late-stage clinical biopharmaceutical company, and wholly owned subsidiary of Innoviva, Inc., is focused on the discovery, development, and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ pathogen-targeted design platform has produced a pipeline of product candidates, including SUL-DUR (targeting Acinetobacter baumannii infections), zoliflodacin (targeting Neisseria gonorrhoeae infections), ETX0282CPDP (targeting Enterobacterales infections) and ETX0462 (targeting Gram-negative infections including Pseudomonas). For more information, visit www.entasistx.com.
About Innoviva
Innoviva is a diversified holding company with a portfolio of royalties and innovative healthcare investments and assets. Its royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/ vilanterol, “FF/VI”), ANORO® ELLIPTA® (umeclidinium bromide/ vilanterol, “UMEC/VI”) and, formerly, TRELEGY® ELLIPTA® (the combination FF/UMEC/VI). Under the Long-Acting Beta2 Agonist (“LABA”) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. ANORO®, RELVAR®, BREO®, TRELEGY® and ELLIPTA® are trademarks of the GSK group of companies.
Innoviva strengthened its portfolio in the hospital and infectious disease space through the acquisition of Entasis Therapeutics Holdings Inc. and La Jolla Pharmaceutical Co. Its development pipeline includes potentially first- and best-in-class medicines for the treatment of multidrug-resistant bacteria, including lead asset SUL-DUR. The Company’s commercial and marketed products include GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections (cIAIs).
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