Immune Response Attenuation There is a theoretical risk that antibody administration may attenuate the endogenous immune response to SARS-CoV-2 and make patients more susceptible to re-infection. 16 NONCLINICAL TOXICOLOGY Carcinogenesis, mutagenesis, and reproductive toxicology studies with bamlanivimab have not been conducted. In toxicology studies in rats, bamlanivimab had no adverse effects when administered intravenously. Non-adverse increases in neutrophils were observed. In tissue cross reactivity studies using human adult and fetal tissues, no binding of clinical concern was detected. 17 ANIMAL PHARMACOLOGIC AND EFFICACY DATA In Vivo Efficacy Pharmacology Prophylactic administration of bamlanivimab to female Rhesus macaques (n=3 or 4 per group) resulted in 1 to 4 log decreases in viral load (genomic RNA) and viral replication 10 (sub-genomic RNA) in bronchoalveolar lavage samples relative to control animals, but less of an impact on viral RNA in throat and nasal swabs following SARS-CoV-2 inoculation. The applicability of these findings to a prophylaxis or treatment setting is not known. 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA 18.1 Mild to Moderate COVID-19 (BLAZE-1) The data supporting this EUA are based on an interim analysis from Part A of BLAZE-1 that occurred after all enrolled subjects completed at least Day 29 of the trial. BLAZE-1 Part A is a randomized, double-blind, placebo-controlled clinical trial studying bamlanivimab for the treatment of subjects with mild to moderate COVID-19 (subjects with COVID-19 symptoms who are not hospitalized). BLAZE-1 enrolled adult patients who were not hospitalized and had at least 1 or more COVID-19 symptoms that were at least mild in severity. Treatment was initiated within 3 days of obtaining the clinical sample for the first positive SARS-CoV-2 viral infection determination. Subjects were treated with a single infusion of bamlanivimab (at doses of 700 mg [N=101], 2,800 mg [N=107], or 7,000 mg [N=101]) or placebo (N=156). At baseline, median age was 45 years (with 12% of subjects aged 65 or older); 55% of subjects were female, 88% were White, 44% were Hispanic or Latino, and 6% were Black; 44% of subjects were considered high risk (as defined in Section 2). Subjects had mild (76%) to moderate COVID-19 (24%); the mean duration of symptoms was 5 days; mean viral load by cycle threshold (CT) was 24 at baseline. The baseline demographics and disease characteristics were well balanced across bamlanivimab and placebo treatment groups. 20