British Journal of Clinical Pharmacology

Viral clearance, pharmacokinetics and tolerability of ensovibep in patients with mild to moderate COVID‐19: A phase 2a, open‐label, single‐dose escalation study

Manon L M Prins 1
Johan L Van Der Plas 1, 2
Maurits F.J.M. Vissers 2, 3
Cécile L Berends 2, 3
Gaby Tresch 4
Marianne Soergel 4
Elena Fernández 4
Nikita Van Den Berge 5
Daniël Duijsings 6
Christof ZITT 4
Vaia Stavropoulou 4
Maya Zimmermann 4
Roxana F Drake 4
Jacobus Burggraaf 2, 3
Geert H Groeneveld 1
Ingrid M. C. Kamerling 1, 2
Show full list: 16 authors
2
 
Centre for Human Drug Research Leiden the Netherlands
4
 
Molecular Partners AG Schlieren Switzerland
5
 
Municipal Health Services (GGD Hollands Midden) Leiden The Netherlands
6
 
Viroclinics Biosciences B.V. Rotterdam The Netherlands
Publication typeJournal Article
Publication date2022-10-24
scimago Q1
SJR1.046
CiteScore6.3
Impact factor3.1
ISSN03065251, 13652125
Pharmacology
Pharmacology (medical)
Abstract
To assess viral clearance, pharmacokinetics, tolerability and symptom evolution following ensovibep administration in symptomatic COVID-19 outpatients.In this open-label, first-in-patient study a single dose of either 225 mg (n = 6) or 600 mg (n = 6) of ensovibep was administered intravenously in outpatients with mild-to-moderate COVID-19 symptoms. Pharmacokinetic profiles were determined (90-day period). Pharmacodynamic assessments consisted of viral load (qPCR and cultures) and symptom questionnaires. Immunogenicity against ensovibep and SARS-CoV-2-neutralizing activity were determined. Safety and tolerability were assessed throughout a 13-week follow-up.Both doses showed similar pharmacokinetics (first-order) with mean half-lives of 14 (SD 5.0) and 13 days (SD 5.7) for the 225- and 600-mg groups, respectively. Pharmacologically relevant serum concentrations were maintained in all subjects for at least 2 weeks postdose, regardless of possible immunogenicity against ensovibep. Viral load changes from baseline at day 15 were 5.1 (SD 0.86) and 5.3 (SD 2.2) log10 copies/mL for the 225- and 600-mg doses, respectively. COVID-19 symptom scores decreased from 10.0 (SD 4.1) and 11.3 (SD 4.0) to 1.6 (SD 3.1) and 3.3 (SD 2.4) in the first week for the 225- and 600-mg groups, respectively. No anti-SARS-CoV-2 neutralizing activity was present predose and all patients had SARS-CoV-2 antibodies at day 91. Adverse events were of mild-to-moderate severity, transient and self-limiting.Single-dose intravenous administration of 225 or 600 mg of ensovibep appeared safe and well tolerated in patients with mild-to-moderate COVID-19. Ensovibep showed favourable pharmacokinetics in patients and the pharmacodynamic results warrant further research in a larger phase 2/3 randomized-controlled trail.

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