Innoviva Specialty Therapeutics Presents Findings from Subgroup Analyses of zoliflodacin in uncomplicated gonorrhea at the 2024 Sexually Transmitted Infections Conference

Waltham, MA – September 19, 2024 – Innoviva Specialty Therapeutics, Inc., a biotechnology company focused on delivering innovative therapies in critical care and infectious diseases, announced today that additional findings on its investigational agent zoliflodacin, a first-in-class oral, single-dose antibiotic for the treatment of uncomplicated gonorrhea, will be delivered as oral presentations during the 2024 Sexually Transmitted Infections Prevention Conference, September 16-19, 2024, in Atlanta, GA.

“Multidrug-resistant strains of gonorrhea are a growing concern worldwide, as these strains can complicate treatment approaches and potentially lead to more serious illness in patients with this highly transmissible disease,” stated Dr. Sarah McLeod, Study Author, and Senior Director of Clinical Microbiology at Innoviva Specialty Therapeutics. “These data expand on the scientific information previously presented from our Phase 3 program and offer further insights that may help direct future disease management strategies.”

In the first oral presentation, “In Vitro Activity of Zoliflodacin against Contemporary Neisseria gonorrhoeae Isolates from the United States,” Neisseria gonorrhoeae clinical isolates from 2020-2021, provided by the U.S. Centers for Disease Control and Prevention (the “CDC”) as part of the CDC GISP surveillance program were tested for susceptibility to zoliflodacin and eight antibiotics used to treat gonorrhea to verify continued activity of zoliflodacin.

In the study, researchers found that zoliflodacin had potent in vitro activity against the 200 N. gonorrhoeae clinical isolates, consistent with previous U.S. surveillance studies. This set of isolates was found to have high rates of resistance to ciprofloxacin and tetracycline. Additionally, zoliflodacin maintains good activity against two strains of N. gonorrhoeae recently isolated in the U.S. that harbor the penA 60.001 allele, which confers ceftriaxone resistance.

The second presentation, “Oral zoliflodacin for treatment of uncomplicated gonorrhea: subgroup analyses by race and region of a global Phase 3 randomized controlled clinical trial,” is a subgroup analysis of data from a global, randomized, controlled, Phase 3 trial that evaluated the efficacy and safety of zoliflodacin. The topline data from this trial was previously disclosed at European Society of Clinical Microbiology and Infectious Disease (ESCMID) 2023, which showed that zoliflodacin was non-inferior to a combination of ceftriaxone and azithromycin (5.31%, 95% confidence interval: 1.38-8.65) with urogenital microbiological cure rates of 90.9% (88.1-93.3) and 96.2% (92.9-98.3), respectively, for the microbiological intent-to-treat population.  Zoliflodacin had a favorable safety profile with comparable overall number of adverse events between the treatment arms. The data are an analysis of clinically relevant subgroups from the Phase 3 trial. The authors found that microbiological cure rates for zoliflodacin in subgroups, including by sex at birth, race, and region, were comparable to the primary endpoint analysis.

Data from these analyses complement the recent Phase 3 clinical trial results and support the continued development of zoliflodacin for patients with uncomplicated gonorrhea.

Zoliflodacin is being developed pursuant to a collaboration agreement between Entasis Therapeutics Limited, an affiliate of Innoviva Specialty Therapeutics, and the Global Antibiotic Research and Development Partnership (GARDP).

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’ product, 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.

Media Contact:

David Patti
Innoviva Corporate Communications
David.patti@inva.com
908.421.5971