The following is a summary of “Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19,” published in the July 2023 issue of Infectious Diseases by Taiwo, et al.
SAB-185, a new fully human IgG polyclonal immunoglobulin product, underwent phase 2 evaluation in nonhospitalized adults with mild-moderate coronavirus disease 2019 (COVID-19).
Participants were given intravenous SAB-185 at either a low dose (3,840 units/kg), or high-dose (10,240 units/kg), or placebo. The main end measures were the detection of nasopharyngeal severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) RNA at study days 3, 7, and 14 and the time it took for symptoms to improve, as well as safety through day 28.
A total of 428 participants were included, with 213 receiving low-dose SAB-185/placebo (107/106) and 215 receiving high-dose SAB-185/placebo (110/105). The proportions of participants with SARS-CoV-2 RNA < LLOQ were higher for SAB-185 versus placebo on days 3 and 7 and similar on day 14. Specifically, high-dose SAB-185 showed a significantly higher proportion with SARS-CoV-2 RNA < LLOQ at day 7 compared to placebo (relative risk 1.23, 95% CI 1.01–1.49). At day 3, SARS-CoV-2 RNA levels were lower with both low-dose and high-dose SAB-185 compared to placebo, with differences in medians of −0.78 log10 copies/mL (P = 0.08) and −0.71 log10 copies/mL (P = 0.10), respectively. However, there was no significant difference in time to symptom improvement between low-dose SAB-185/placebo and high-dose SAB-185/placebo (median 11/10 days, P = 0.24, and 8/10 days, P = 0.50, respectively). Adverse events of grade ≥3 occurred in 5%/13% of low-dose SAB-185/placebo and 9%/12% of high-dose SAB-185/placebo.
SAB-185 demonstrated modest antiviral activity and was safe and generally well tolerated in mostly low-risk nonhospitalized adults with COVID-19.
Source: academic.oup.com/jid/article-abstract/228/2/133/6994141?redirectedFrom=fulltext
