Early in the COVID-19 pandemic, Appili joined Dr. Reddy’s Laboratories, Global Response Aid, and FUJIFILM Toyama Chemical to oversee the clinical evaluation of broad spectrum oral COVID-19 antiviral candidate favipiravir. Phase 3 results were reported in November 2021.
A global partnership to fight COVID-19
Announced on October 30, 2020, Appili joined partners FUJIFILM, Dr. Reddy’s, and Global Response Aid to develop oral antiviral Avigan® / Reeqonus™ (favipiravir) for COVID-19.
Appili joined the consortium to oversee the pivotal Phase 3 clinical trial program in support of regulatory submissions worldwide with specific responsibility for US and Canadian clinical trials conducted on behalf of the consortium. Dr. Reddy’s and Global Response Aid (GRA) continued to be responsible for the research and development, manufacturing, commercialization, and distribution of Avigan® / Reeqonus™ (favipiravir), with FFTC supplying its knowledge base, including clinical data and intellectual property, in support of the consortium’s operations.
Appili announced top-line results from its lead Phase 3 trial PRESECO, evaluating favipiravir for the early treatment of mild-to-moderate COVID-19 on November 12, 2021, reporting that the study did not achieve statistical significance for the primary endpoint of time to sustained clinical recovery. This multinational trial enrolled 1,231 patients from 38 study sites across the United States, Mexico, and Brazil. Additional analyses are ongoing.