Background

• There is an urgent need for effective treatment options that are easily administered and readily implementable in health systems globally to reduce the impact of COVID-19
• Molnupiravir (MOV) is an orally administered ribonucleoside prodrug of β-D-N4- hydroxycytidine (NHC). NHC is converted to the pharmacologically active triphosphate form (NHC-TP), with sub-micromolar potency against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
• MOV acts by the mechanism of “viral error catastrophe”, which occurs when NHC-TP is incorporated into the viral genome by the viral polymerase during replication, resulting in an accumulation of mutations in the viral RNA.2 Once a tolerated threshold of viral RNA mutations has been exceeded, inhibition of viral replication and production of non-infectious virus lead to viral extinction
  • The MOVe-OUT and MOVe-IN phase 2/3 trials are evaluating the efficacy, safety, and pharmacokinetics (PK) of MOV in adults with laboratory-confirmed COVID-19
  • Based on phase 2 results from both trials, only the outpatient trial MOVe-OUT has proceeded
    to phase 3, since MOV provided no clear clinical benefit to hospitalized patients 3,4

By Akshita Chawla, Youfang Cao, Julie Stone, Ruthie Birger, Susanne Sardella, Hong Wan, Leah A. Gaffney, Alex Therien, Nicholas Murgolo, Wendy P. Painter, George R. Painter, Wayne Holman, Jay A. Grobler, Matthew L. Rizk, Joan R. Butterton, Matthew G. Johnson, Michelle L. Brown, Amanda Paschke, Carisa De Anda, Wei Gao

Presented at the 31st ECCMID European Congress of Clinical Microbiology and Infectious Diseases, July 9–12, 2021