Gilead has announced top-line Phase 3 trial results of remdesivir in patients with COVID-19. The drug is indicated in moderate COVID-19 pneumonia.
The company announced Phase 3 SIMPLE trial, an open-label study, which evaluated 5-day and 10-day courses. The drug is compared with the standard of care. 65% of patients on remdesivir plus standard of care group had better clinical improvement at day 11 compared to patients on standard of care alone. No statistically significant improvement was observed in the 10-day course.
ABOUT SIMPLE TRIALS
The company is conducting two Phase 3 SIMPLE trials, which evaluated the efficacy across 180 centers, including centers in the USA, China, Germany, France, the UK, Italy, Japan, Korea, Netherlands, Singapore, and Spain.
Six percent of patients on the remdesivir group required oxygen compared to 11% in patients who were on the standard of care.
70% of patients on 5-day remdesivir had ≥ 2-point improvement in original scale compared to 61% in patients on standard of care
76% of patients on 5-day remdesivir had ≥ 1-point improvement in ordinal scale compared to 66% of patients who were administered with the standard of care
The company is further planning to enrol 5,600 patients, including severe patients who are on mechanical ventilation.
The second trial is intended to demonstrate the efficacy and safety in patients administered with 5-day and 10-day course. The initial phase included 600 patients.
Remdesivir is a broad spectrum antiviral agent. The drug is a monophosphoramidate prodrug, which is an adenosine analogue indicated for treating filoviruses, paramyxoviruses, pneumoviruses, and coronaviruses.
Japan’s Ministry of Health, Labour, and Welfare has already approved the product for patients infected with SARS-CoV-2. The Food and Drug Administration has recommended the product in emergency use.