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Innoviva Specialty Therapeutics Presents New Data on its Critical Care Antibiotic Therapy Portfolio at Infectious Disease Week (IDWeek) 2023

October 12, 2023 – Pharmaceutical – IDWeek 2023, Innoviva, infectious diseases

Oral presentation highlights new findings about the efficacy of XACDURO for the treatment of monomicrobial and polymicrobial Acinetobacter baumannii-calcoaceticus infections
Researchers share global surveillance data on the in vitro activity of XERAVA (eravacycline) for injection on resistant isolates and Gram-positive clinical pathogens
Total of nine presentations on XACDURO and XERAVA to be revealed during IDWeek 2023

11 October 2023 — Massachusetts, UK — Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc, announced today plans to present an oral abstract and four poster sessions from their portfolio of US Food and Drug Administration (FDA)-approved critical care and infectious disease therapies at IDWeek 2023, October 11-15, held in Boston, Massachusetts, US.

The company will deliver one oral abstract presentation and two poster sessions highlighting findings on their newly approved therapy, XACDURO (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, which is the first and only antibiotic specifically developed to target the Acinetobacter pathogen in adults. XACDURO is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. In addition, four company-sponsored research studies on XACDURO will also be presented by the company’s research partners in poster sessions.

“Antibiotic-resistant pathogens are one of the most significant and challenging threats to healthcare providers on the frontlines of infectious disease care,” said Margaret Koziel, MD, chief medical officer, Innoviva Specialty Therapeutics. “IDWeek is an opportunity for us and for our research partners to share new clinical insights that help us better understand these therapies on a deeper level to improve treatment strategies.”

Researchers from Innoviva Specialty Therapeutics will also present new surveillance data on XERAVA (eravacycline), an anti-bacterial for the treatment of complicated intra-abdominal infections (cIAI) caused by multidrug-resistant bacteria during the scientific poster sessions.

Company Presentations:

Oral Abstract Presentation

Efficacy of Sulbactam-Durlobactam (SUL-DUR) Compared to Colistin (COL) Against Acinetobacter baumannii-calcoaceticus Complex (ABC) Monomicrobial and Polymicrobial Infections in a Phase 3 Trial
Authors: Alita A. Miller, Sarah M. McLeod, Adam Shapiro, Khurram Rana, David Altarac
Innoviva Specialty Therapeutics, Waltham, MA, United States
Session Date: Thursday, October 12, 2023; 10:30 – 10:45 AM ET
Session Topic: Clinical Trials
Session Location: 102 AB

Poster Sessions

Pharmacometric Analyses to Support Sulbactam-Durlobactam (SUL-DUR) Dosing Regimens in Patients with Altered Renal Function (2549)
Authors: Kajal Larson, Sujata Bhavnani, Jeffrey Hammel, Anthony Cammarata, John O’Donnell, Christopher Rubino; Innoviva Specialty Therapeutics, Waltham, MA, United States, Institute for Clinical Pharmacodynamics, Inc. – Schenectady, NY United States
Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET
Session Topic: PK/PD Studies
Session Location: Hall B + C
In Vitro Susceptibility of Recent Clinical Isolates of aeruginosa and Enterobacterales to Imipenem or Meropenem Alone or in Combination with Sulbactam-Durlobactam (2138)
Authors: Sarah M. McLeod, Nicole M. Carter, Samir H. Moussa, Alita A. Miller;
Innoviva Specialty Therapeutics, Waltham, MA, United States
Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET
Session Topic: Antimicrobial Novel Agents
Session Location: Hall B + C
Surveillance of Eravacycline Against Enterobacterales and Non-Fermenter Clinical Isolates, Including Resistant Isolates, Collected Worldwide from Multiple Infection Sites During 2021 (2132)
Authors: Stephen Hawser, Nimmi Kothari, Federica Monti, Tony Hodges, Kristie Zappas; IHMA Europe, Monthey (Valais), Switzerland; Innoviva Specialty Therapeutics, Inc, Waltham (MA), United States
Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET
Session Topic: Antimicrobial Novel Agents
Session Location: Hall B + C
Surveillance of Eravacycline Against Gram-Positive Clinical Pathogens, Including Resistant Isolates, Collected Worldwide From Multiple Infection Sites During 2021 (2133)
Authors: Stephen Hawser, Nimmi Kothari, Federica Monti, Tony Hodges, Kristie Zappas; IHMA Europe, Monthey (Valais), Switzerland; Innoviva Specialty Therapeutics, Inc, Waltham (MA), United States
Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET
Session Topic: Antimicrobial Novel Agents
Session Location: Hall B + C

Company-Sponsored Research Presentations:

Poster Sessions

In vitro Synergy of the Combination of Sulbactam-Durlobactam and Cefepime at Clinically Relevant Concentrations Against baumannii, P. aeruginosa, and Enterobacterales (2121)
Authors: Aliaa Fouad, PhD, David P. Nicolau, PharmD, FCCP, FIDSA, and Christian M. Gill, PharmD, Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, CT, United States, Division of Infectious Diseases, Hartford Hospital, Hartford, CT United States
Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET
Session Topic: PK/PD Studies
Session Location: Hall B + C

Ex Vivo Assessment of Sulbactam-Durlobactam (SUL-DUR) Clearance During Continuous Renal Replacement Therapy (CRRT) (2526)
Authors: Yasmeen Abouelhassan, Yuwei Shen, Xiaoyi Ye, David P Nicolau, Joseph L. Kuti Ctr. for Anti-Infect. Res. & Dev., Hartford Hospital, Hartford, CT Inpatient Hemo-Therapeutics, Hartford Hospital, Hartford, CT United States
Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET
Session Topic: New Antimicrobial Drug Development
Session Location: Hall B + C

(2515) Evaluation of the Equivalency of the Oxoid Sulbactam-Durlobactam (10/10µg) Antimicrobial Disc to the CLSI M07 Broth Microdilution Frozen Reference Method
Authors: K. L. Hajek B.S., A.J Lovatt BSc., S. Bhalerao PhD., N. Khan BSc., D.T Staats M.S. M.M Hendrix B.S., N.M Holliday B.S., C.C Knapp M.S.
Thermo Fisher Scientific, Cleveland, OH, United States; Thermo Fisher Scientific, Basingstoke, United Kingdom
Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM
Session Topic: New Antimicrobial Drug Development
Session Location: Hall B + C

(2517) Activity of Sulbactam-Durlobactam, Antibacterial Combinations, and Comparators Against a Challenge Set of 66 Acinetobacter Baumannii-Calcoaceticus Species Complex Isolates
Authors: MD Huband, RE Mendes, G Bartleson, H Huynh, M Castanheira
JMI Laboratories, North Liberty, IA, United States
Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM
Session Topic: New Antimicrobial Drug Development
Session Location: Hall B + C

About Innoviva Specialty Therapeutics

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc, is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, 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 in adults. Innoviva Specialty Therapeutics’ products, through its affiliate, Entasis Therapeutics Inc, include XACDURO (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). For more information about Innoviva Specialty Therapeutics, please visit here.

About Innoviva

Innoviva, Inc, is a diversified holding company with a portfolio of royalties and other healthcare assets, including Innoviva Specialty Therapeutics, a subsidiary focused on delivering innovative therapies in critical care and infectious disease. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR/BREO ELLIPTA (fluticasone furoate/vilanterol, FF/VI) and ANORO ELLIPTA (umeclidinium bromide/vilanterol, 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 and BREO are trademarks of the GSK group of companies. For more information on Innoviva, please visit here.