The pre-specified primary endpoint in this Phase 2 trial was change in viral load from baseline to Day 11 for bamlanivimab versus placebo. Most subjects, including those receiving placebo, effectively cleared virus by Day 11 (Figure 1). Figure 1: SARS-CoV-2 viral load change from baseline by visit. While viral load was used to define the primary endpoint in this Phase 2 trial, the most important evidence that bamlanivimab may be effective came from the predefined secondary endpoint of COVID-19-related hospitalizations or emergency room visits within 28 days after treatment. A lower proportion of bamlanivimab-treated subjects progressed to COVID-19-related hospitalization or emergency room visits compared to placebo-treated subjects (Table 3). Results for this endpoint were suggestive of a relatively flat dose-response relationship. Table 3: Proportion of Subjects with Events of Hospitalization or Emergency Room Visits within 28 Days After Treatment Proportion of a Treatment N Events Subjects % Placebo 156 9 6% bamlanivimab 700 mg 101 1 1% bamlanivimab 2800 mg 107 2 2% bamlanivimab 7000 mg 101 2 2% All bamlanivimab doses 309 5 2% a N = number of treated patients in analysis. 21
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