Innoviva Specialty Therapeutics Presents Findings from Subgroup Analyses of Zoliflodacin in Uncomplicated Gonorrhea at the 2024 Sexually Transmitted Infections Conference

Waltham, MA – September 16, 2024 – Innoviva Specialty Therapeutics, Inc. (“Innoviva Specialty Therapeutics”), 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 (STI), 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.”

“The first oral presentation, titled “In Vitro Activity of Zoliflodacin against Contemporary Neisseria gonorrhoeae Isolates from the United States,” aimed to determine the susceptibility of contemporary Neisseria gonorrhoeae isolates to zoliflodacin and eight other antibiotics commonly used to treat gonorrhea. The Global Antibiotic Research and Development Partnership (GARDP) supported the study through funding from the German Federal Ministry of Health. It included Neisseria gonorrhoeae clinical isolates collected from 2020 to 2021, which were provided by the U.S. Centers for Disease Control and Prevention as part of the CDC GISP surveillance program.

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 efficacy 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 efficacy 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 consistent 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).

This GARDP-led Phase 3 trial was funded with support from the governments of Germany (BMBF and BMG), UK (GAMRIF, part of DHSC, and DFID), Japan (MHLW), the Netherlands (Ministries of VWS and BZ), Switzerland (FOPH), The Grand Duchy of Luxembourg, as well as the Canton of Geneva, South African Medical Research Council (SAMRC), and the Leo Model Foundation. This builds on the critical phase 2 clinical trial sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID).

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