Public/Private Partnerships Keep Gonorrhea Drug Development Alive
Only two new antibiotics are in Phase III trials for gonorrhea: Entasis’ zoliflodacin, in collaboration with the Global Antibiotic R&D Partnership, and GlaxoSmithKline’s gepotidacin in partnership with the US Biomedical Advanced R&D Authority.
You may also be interested in...
Therapyx and Intravacc are optimizing a candidate gonorrhea vaccine following promising results in primates and the granting of a three-year SBIR award by the US NIAID.
Regulatory incentives have been successful at attracting developers to antibiotic R&D, but significant medical advances have stubbornly remained rare. Now the pipeline has produced the first novel antibiotic to receive breakthrough status from US FDA and some Phase III trials are raising the efficacy bar to superiority.
US FDA Revisits Gonorrhea Drug Development As Fast-Emerging Resistance, Preclinical Challenges Hold Back New Products
From animal models to non-inferiority margins, US FDA is seeking new perspectives on gonorrhea R&D, including how to incorporate extragenital infections into clinical programs.