Waltham - 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.
Beyond the zoliflodacin posters, Innoviva Specialty Therapeutics will also be presenting three additional posters at the meeting that feature new data for XERAVA and XACDURO.
Results from the Phase 3 Zoliflodacin Trial
The Phase 3 non-inferiority trial analyzed a total of 930 patients with uncomplicated gonorrhea, including women, adolescents and people living with HIV, making it the largest clinical trial ever conducted for a new treatment against gonorrhea infection, with 16 trial sites in regions with a high prevalence of gonorrhea across five countries, including Belgium, the Netherlands, South Africa, Thailand, and the U.S. The trial compared a single oral 3g dose of zoliflodacin to a globally recognized standard of care regimen (500mg ceftriaxone intramuscular [IM] plus 1g oral azithromycin). The primary efficacy endpoint was microbiological response at the urogenital site (cure or failure) at the Test-of-Cure (ToC) visit 6+/-2 days after treatment. Secondary analyses included microbiological cure at rectal or pharyngeal sites and safety.
The trial met its primary efficacy endpoint, with zoliflodacin (oral, 3g dose) demonstrating non-inferiority to ceftriaxone (IM, 500mg) plus azithromycin (oral, 1g). In the micro-intent-to-treat (micro-ITT) population (n=744), zoliflodacin achieved a microbiological cure rate of 90.9%, a 5.3% difference compared to ceftriaxone and azithromycin which achieved a 96.2% cure rate (95% CI: 1.4%, 8.7%). Microbiological cure rates at extragenital sites were comparable between treatment arms.
Oral zoliflodacin 3g was generally well tolerated and emergent adverse events were comparable between treatment arms (46.2% vs 46.4%). No deaths or other serious adverse events were reported.
About Oral Zoliflodacin
Zoliflodacin is a potential first-in-class, orally administered, single dose antibiotic with a novel mechanism of action that is currently in development for the treatment of uncomplicated gonorrhea. In a Phase 3 clinical trial, zoliflodacin met the primary efficacy endpoint by demonstrating non-inferiority compared to a globally recognized standard of care regimen (500mg ceftriaxone intramuscular [IM] plus 1g oral azithromycin). Zoliflodacin was found to be generally well tolerated with the overall rate of adverse events comparable between the two arms, and the majority of adverse events were mild to moderate. In vitro studies have shown that it is active against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone, and azithromycin, with no cross-resistance with other antibiotics.
About Gonorrhea
Gonorrhea is widely prevalent worldwide, with the World Health Organization estimating 82 million new cases worldwide in 20201, making it the second most prevalent sexually transmitted bacterial infection worldwide after Chlamydia trachomatis. In the U.S., gonorrhea is the second most prevalent sexually transmitted bacterial infection, with an estimated 1.6 million new infections each year.2 The bacterium Neisseria gonorrhoeae has gradually developed resistance to many classes of antibiotics used to treat these infections and as a result, ceftriaxone, given as a single intramuscular injection, has become the last available recommended treatment for gonorrhea globally.
About GARDP
The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit organization that develops new antibiotic treatments for drug-resistant bacterial infections that pose the greatest threat to human health, and makes them accessible to the people who need them. It puts public health needs at the centre of antibiotic drug development to address the immediate crisis of antimicrobial resistance (AMR). Its work is funded by the governments of Australia, Germany, Japan, Monaco, the Netherlands, the Public Health Agency of Canada, South Africa, Switzerland, the United Kingdom, the Canton of Geneva, the European Union (via the Health Emergency Preparedness and Response Authority), as well as the RIGHT Foundation, Wellcome and other private foundations. GARDP was created by the World Health Organization and the Drugs for Neglected Diseases initiative (DNDi) in 2016 and legally registered as the GARDP Foundation in Geneva, Switzerland in 2018.
About Innoviva Specialty Therapeutics, Inc.
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). Our Phase 3 development pipeline includes zoliflodacin, a novel treatment for uncomplicated gonorrhea in adults.
About Innoviva, Inc.
Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (IST), and a portfolio of strategic investments in healthcare assets. Innoviva's royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (GSK). Innoviva is entitled to receive royalties from GSK on sales of RELVAR/BREO ELLIPTA and ANORO ELLIPTA. Innoviva's other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including 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 and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including 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.
Forward Looking Statements
This press release contains certain 'forward-looking' statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words 'anticipate', 'expect', 'goal', 'intend', 'objective', 'opportunity', 'plan', 'potential', 'target' and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR/BREO ELLIPTA, ANORO ELLIPTA, GIAPREZA, XERAVA and XACDURO in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva's growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (COVID-19); the timing, manner and amount of capital deployment, including potential capital returns to stockholders and risks related to the Company's growth strategy. Other risks affecting Innoviva are described under the headings 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' contained in Innoviva's Annual Report on Form 10-K for the year ended December 31, 2022, and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.
Contact:
David Patti
Tel: +1 908.421.5971
Email: David.Patti@inva.com
Tel: +1 212.600.1902
Email: Innoviva@argotpartners.com
INNOVIVA, INC. 
