Innoviva Specialty Therapeutics’ Positive Phase 3 Oral Zoliflodacin Data for the Treatment of Uncomplicated Gonorrhea Announced at ESCMID Global 2024

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), today announced that positive results from the Phase 3 oral zoliflodacin trial will be highlighted in an oral presentation given by the Global Antibiotic Research & Development Partnership (GARDP) at the European Society of Clinical Microbiology and Infectious Disease Global Congress (ESCMID Global 2024) taking place April 27-30, 2024, in Barcelona, Spain. Zoliflodacin is a first-in-class spiropyrimidinetrione, single dose, oral antibiotic that is being developed in partnership with GARDP for the treatment of uncomplicated gonorrhea.

“As a single dose, oral antibiotic, zoliflodacin, if approved, could have a profound effect on how physicians across the globe approach the treatment of gonorrhea infections, potentially improving patient access and compliance while helping to reduce the spread of antibiotic-resistant strains of gonorrhea,” said David Altarac, M.D., Chief Medical Officer of Innoviva Specialty Therapeutics. “The presentation of these data for this innovative investigational therapy is an important step in advancing our clinical pipeline strategy, as we now turn our focus on regulatory filing requirements in the U.S.”

“Presenting these findings to the scientific community for the first time is a significant milestone in the journey of this important antibiotic in the fight against Neisseria gonorrhoeae, a World Health Organization priority pathogen,” said Dr. Alison Luckey, Senior Medical Lead for GARDP’s Sexually Transmitted Infections programme. “These positive findings not only represent a step forward in the treatment of gonorrhoea if approved, but also demonstrate the pivotal role that this public-private partnership between GARDP and Innoviva Specialty Therapeutics has in addressing the public health failure at the heart of the global antimicrobial resistance (AMR) crisis.”

In November 2023, the two organizations announced that the Phase 3 zoliflodacin trial met its primary endpoint, demonstrating statistical non-inferiority of microbiological cure at the urogenital site when compared to treatment with intramuscular injection of ceftriaxone and oral azithromycin, currently the only remaining global standard of care regimen for the treatment of uncomplicated gonorrhea.

In addition to the Phase 3 topline data, GARDP will also be presenting three additional posters highlighting details of zoliflodacin’s safety profile and additional microbiological data from the Phase 3 trial, as well as data from a drug-drug interaction pharmacokinetic trial. GARDP and Innoviva Specialty Therapeutics plan to submit the Phase 3 zoliflodacin data for future publication in a medical journal.