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Latest From Entasis Therapeutics Holdings Inc.
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.
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.
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.
Private Company Edition: The Novo Holdings Repair Impact Fund wants to fund another round of antimicrobial resistance efforts. Also, Atlas Venture raised a new $400m fund, Everest closed a $310m series C round and Cognition received a $78.5m grant.