GARDP and Entasis Therapeutics Initiate Global Phase 3 Trial of Zoliflodacin, a First-in-Class Oral Antibiotic for the Treatment of Gonorrhea
- 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 Organizationas a priority pathogen
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
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
"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.
The trial is expected to enroll approximately 1,000 adults with urogenital gonorrhea from clinical trial sites in
“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
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.
1 Gonorrhea: CDC Fact Sheet
2 More than 1 million new curable sexually transmitted infections every day
3 WHO publishes list of bacteria for which new antibiotics are urgently needed
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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Source: Entasis Therapeutics Holdings Inc.