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favipiravir / Generic mfg.Appili Submits Protocol for a Phase 3 Study Evaluating Favipiravir for the Treatment of Patients with COVID-19 Infections to the US FDA (Businesswire) - Sep 11, 2020 - "Appili Therapeutics Inc....today announced that it has submitted a new protocol to its open investigational new drug application (IND)...to conduct a Phase 3 clinical study evaluating favipiravir in the early treatment outpatient setting for adult COVID-19 infections....Investigators will seek to determine if favipiravir is a safe and effective treatment for mild-to-moderate COVID-19 infections....Appili plans to recruit 826 eligible participants....Appili expects to initiate trial recruitment in the Fall of 2020. In a sub study, researchers intend to further examine 136 trial participants to evaluate favipiravir’s effect on viral shedding."CT-P59 / CelltrionCelltrion Announces Positive Interim Results From Phase I Trial of CT-P59, an Anti-COVID-19 Monoclonal Antibody Treatment Candidate (Businesswire) - Sep 11, 2020 - P1, N=32; NCT04525079; Sponsor: Celltrion; "Celltrion has also launched commercial production of CT-P59 as part of the preparation process; The results demonstrated no significant drug-related adverse events (AEs), and importantly there were no adverse events from the maximum tolerated dose cohort.....'We intend to request emergency use authorisation'....Celltrion...plans to conduct further global Phase II and III trials in 500 patients from 12 countries including Korea. Celltrion anticipates the enrolment of a total of 3,000 patients including those involved in the prevention clinical trial....The company anticipates the development of the anti-COVID-19 monoclonal antibody treatment candidate will be complete by the first half of 2021."
