Randomized, open label trial will assess the efficacy and safety of zoliflodacin versus a combination of azithromycin and ceftriaxone, the current standard of care
87 million new gonorrhea infections estimated each year; Neisseria gonorrhoeae increasingly resistant to globally recommended treatments and classified by the World Health Organization as a priority pathogen
GENEVA and WALTHAM, Mass., Sept. 30, 2019 (GLOBE NEWSWIRE) -- The Global Antibiotic Research and Development Partnership (GARDP), a not for profit organization developing new treatments for drug resistant infections, and Entasis Therapeutics (ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, today jointly announced the initiation of a global phase 3 pivotal trial of zoliflodacin. Zoliflodacin is a novel, first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhea. Following positive phase 2 results previously published in the New England Journal of Medicine (NEJM), Entasis and GARDP have partnered to complete late stage development, with GARDP fully-funding and sponsoring the global phase 3 trial.
Gonorrhea is a common sexually transmitted infection (STI) affecting both men and women, particularly between 15 and 24 years old.1 Globally the infection rate of gonorrhea is increasing, with 87 million new cases estimated each year.2 Uncomplicated gonorrhea infections carry high morbidity, enhance transmission of other sexually transmitted diseases and are highly stigmatized. Gonorrhea is caused by the bacterium Neisseria gonorrhoeae, which has progressively developed resistance to globally-recommended treatments and has been identified by the World Health Organization as among a family of ‘priority pathogens’ posing the greatest threat to global health.3
Teodora Wi, WHO Medical Officer for STIs, said: “Gonorrhea rates are increasing, resulting in substantial morbidity and a huge psychosocial and economic cost worldwide. At the same time, we are observing increasing resistance to the last line-options for treatment in Neisseria gonorrhoeae. That is why there is an urgent need for new treatments and why the World Health Organization is supporting GARDP.”
"The initiation of the phase 3 trial of zoliflodacin is an important milestone and brings hope for people affected by this disease. Our partnership with Entasis is critical for preventing the dire scenario of untreatable gonorrhea and controlling this infection,” said Dr. Manica Balasegaram, Executive Director of GARDP. “The global nature of the trial, across four continents, represents our commitment to ensuring this treatment is available to anyone who needs it, wherever they live.”
The trial is expected to enroll approximately 1,000 adults with urogenital gonorrhea from clinical trial sites in the United States, Netherlands, Thailand and South Africa. Patients included in the trial will be randomized (2:1) to receive either zoliflodacin or a combination of ceftriaxone and azithromycin and will be assessed one week later for persistence of the infection. Data from the phase 3 clinical trial is anticipated in 2021.
“The phase 3 trial of zoliflodacin marks the last major clinical trial for our gonorrhea program. Entasis’ partnership with GARDP reflects our commitment to enable global access of this potential novel oral treatment for a disease that is quickly becoming resistant to all currently available antibiotics,” said Manos Perros, PhD, President and Chief Executive Officer of Entasis Therapeutics. “We both believe a solution lies with an oral treatment option, which not only overcomes existing resistance but also offers significant benefits compared to the current standard of care of one or more intramuscular injections. We look forward to continuing our relationship with GARDP as we progress this global phase 3 trial.”
Under the partnership agreement, GARDP is responsible for the phase 3 trial and pharmaceutical development activities for zoliflodacin to support regulatory approval and market access and availability. GARDP has commercial rights to zoliflodacin in up to 168 low- and select middle-income countries, while Entasis retains commercial rights in the rest of the world. The phase 3 trial initiation marks an important milestone for this novel industry and non-profit partnership in jointly developing a novel antibiotic and building a strategic plan for successful market access within the countries that have high rates of gonorrhea and for patients who need it most.
The Global Antibiotic Research and Development Partnership (GARDP) is a not-for-profit developing new and improved treatments for drug resistant infections. Created by the WHO and Drugs for Neglected Diseases initiative (DNDi), GARDP is an essential element of the WHO Global Action Plan on Antimicrobial Resistance. www.gardp.org
Entasis is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ pathogen-targeted design platform has produced a pipeline of product candidates, including sulbactam-durlobactam (targeting Acinetobacter baumannii infections), zoliflodacin (targeting Neisseria gonorrhoeae), and ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is also using its platform to develop a novel class of antibiotics, non-β-lactam inhibitors of the penicillin-binding proteins (NBPs) (targeting Gram-negative infections). For more information, visit www.entasistx.com
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Entasis’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during non-clinical or clinical studies, clinical site activation rates or clinical trial enrolment rates that are lower than expected and changes in expected or existing competition, changes in the regulatory environment, failure of Entasis’ collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Many of these factors are beyond Entasis’ control. These and other risks and uncertainties are described more fully in the Entasis’ filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Forward-looking statements contained in this announcement are made as of this date, and except as required by law, Entasis assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
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