Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19

ACTIV-2/A5401 Study Team

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

Abstract

Background: SAB-185, a novel fully human IgG polyclonal immunoglobulin product, underwent phase 2 evaluation for nonhospitalized adults with mild-moderate coronavirus disease 2019 (COVID-19). Methods: Participants received intravenous SAB-185 3840 units/kg (low-dose) or placebo, or 10 240 units/kg (high-dose) or placebo. Primary outcome measures were nasopharyngeal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA < lower limit of quantification (LLOQ) at study days 3, 7, and 14, time to symptomatic improvement, and safety through day 28. Results: Two-hundred thirteen participants received low-dose SAB-185/placebo (n = 107/106) and 215 high-dose SAB-185/placebo (n = 110/105). The proportions with SARS-CoV-2 RNA < LLOQ were higher for SAB-185 versus placebo at days 3 and 7 and similar at day 14, and significantly higher at day 7 for high-dose SAB-185 versus placebo only, relative risk 1.23 (95% confidence interval, 1.01-1.49). At day 3, SARS-CoV-2 RNA levels were lower with low-dose and high-dose SAB-185 versus placebo: differences in medians of -0.78 log10 copies/mL (P =. 08) and -0.71 log10 copies/mL (P =. 10), respectively. No difference was observed in time to symptom improvement: median 11/10 days (P =. 24) for low-dose SAB-185/placebo and 8/10 days (P =. 50) for high-dose SAB-185/placebo. Grade ≥3 adverse events occurred in 5%/13% of low-dose SAB-185/placebo and 9%/12% of high-dose SAB-185/placebo. Conclusions: SAB-185 was safe and generally well tolerated and demonstrated modest antiviral activity in predominantly low-risk nonhospitalized adults with COVID-19. Clinical Trials Registration. NCT04518410.

Original languageEnglish (US)
Pages (from-to)133-142
Number of pages10
JournalJournal of Infectious Diseases
Volume228
Issue number2
DOIs
StatePublished - Jul 15 2023

Funding

Potential conflicts of interest. B. T. has received honoraria for advisory boards and consulting from Gilead Sciences. K. W. C. has received research funding to the institution from Merck Sharp & Dohme and consulted for Pardes Biosciences. E. S. D. receives consulting fees from Gilead Sciences, Merck, and GSK/ViiV; and research support through the institution from Gilead Sciences and GSK/ViiV. D. A. W. has received funding to the institution to support research and honoraria for advisory boards and consulting from Gilead Sciences. J. Z. L. has consulted for Abbvie. A. L. G. reports contract testing from Abbott, Cepheid, Novavax, Pfizer, Janssen, and Hologic; and research support from Gilead and Merck, outside of the described work. J. J. E. is an ad hoc consultant to GSK/VIR; and data monitoring committee chair for Adagio phase 3 studies. J. S. C. has consulted for Merck and Company. D. M. S. has consulted for Fluxergy, Kiadis, Linear Therapies, Matrix BioMed, Arena Pharmaceuticals, VxBiosciences, Model Medicines, Bayer Pharmaceuticals, Signant Health, and Brio Clinical. C. B. and T. L. are employees of SAB Biotherapeutics. All other authors report no potential conflicts. Financial support . This work was supported by the National Institute of Allergy and Infectious Diseases, National Institutes of Health (grant numbers UM1AI068636, UM1AI068634, and UM1AI106701). Investigational product SAB-185 was donated by SAB Biotherapeutics.

Keywords

  • COVID-19
  • SAB-185
  • antibody
  • polyclonal
  • transchromosomic
  • treatment

ASJC Scopus subject areas

  • General Medicine

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