British Journal of Clinical Pharmacology, volume 89, issue 7, pages 2295-2303
Ensovibep, a SARS‐CoV‐2 antiviral DARPin, is safe and well tolerated in healthy volunteers: results of a first‐in‐human, ascending single‐dose Phase 1 study
Nina Stojcheva
1
,
Stacy Gladman
2
,
Marianne Soergel
1
,
Christof ZITT
1
,
Roxana Drake
1
,
Tony Lockett
3
,
Carine Marchand
1
,
Pierre Fustier
1
,
Vaia Stavropoulou
1
,
Elena Fernandez
1
,
Nathana Lopes Pettigiani
1
,
Kate Watkins
2
,
Adeep Puri
2
,
Randall Watson
1
,
Philippe Legenne
1
,
Michael T. STUMPP
1
,
M. J. BOYCE
2
1
Molecular Partners AG, Schlieren Zurich Switzerland
|
2
HMR, Hammersmith Medicines Research London UK
|
Publication type: Journal Article
Publication date: 2023-05-08
Quartile SCImago
Q1
Quartile WOS
Q2
Impact factor: 3.4
ISSN: 03065251, 13652125
Pharmacology
Pharmacology (medical)
Abstract
Aims
This study aimed to assess safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) effects of ensovibep, a designed ankyrin repeat protein antiviral being evaluated as a COVID‐19 treatment, in healthy volunteers in a first‐in‐human ascending single‐dose study.
Methods
Subjects were dosed intravenously, in a randomized double‐blinded manner, with either ensovibep at 3, 9 or 20 mg/kg or with placebo, and followed until Day 100. PK and safety were assessed throughout the study duration. Immunogenicity and PD via viral neutralization in serum were also assessed.
Results
All adverse events were of mild to moderate severity, and no serious adverse events were observed. One subject who received the 20‐mg/kg dose presented with moderate hypersensitivity vasculitis 3 weeks after infusion, which fully resolved using standard procedures. In most subjects ensovibep showed expected mono‐exponential decline with a half‐life of around 2 weeks. Anti‐drug antibodies were detected in 15 of 17 subjects, with the earliest onset detected on Day 29. Viral neutralization assays on subject serum showed effective viral neutralization over the first 3 weeks following dosing with titre values in a dose dependent manner.
Conclusion
Ensovibep proved safe in this first‐in‐human safety study and exhibited PK and PD parameters consistent with the expected treatment period required for acute COVID‐19 infection.
Top-30
Citations by journals
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1
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FEBS Open Bio
1 publication, 33.33%
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Open Forum Infectious Diseases
1 publication, 33.33%
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Russian Chemical Reviews
1 publication, 33.33%
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1
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Citations by publishers
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1
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Wiley
1 publication, 33.33%
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Oxford University Press
1 publication, 33.33%
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Autonomous Non-profit Organization Editorial Board of the journal Uspekhi Khimii
1 publication, 33.33%
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1
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- We do not take into account publications without a DOI.
- Statistics recalculated only for publications connected to researchers, organizations and labs registered on the platform.
- Statistics recalculated weekly.
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Stojcheva N. et al. Ensovibep, a SARS‐CoV‐2 antiviral DARPin, is safe and well tolerated in healthy volunteers: results of a first‐in‐human, ascending single‐dose Phase 1 study // British Journal of Clinical Pharmacology. 2023. Vol. 89. No. 7. pp. 2295-2303.
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Stojcheva N., Gladman S., Soergel M., ZITT C., Drake R., Lockett T., Marchand C., Fustier P., Stavropoulou V., Fernandez E., Pettigiani N. L., Watkins K., Puri A., Watson R., Legenne P., STUMPP M. T., BOYCE M. J. Ensovibep, a SARS‐CoV‐2 antiviral DARPin, is safe and well tolerated in healthy volunteers: results of a first‐in‐human, ascending single‐dose Phase 1 study // British Journal of Clinical Pharmacology. 2023. Vol. 89. No. 7. pp. 2295-2303.
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TY - JOUR
DO - 10.1111/bcp.15747
UR - https://doi.org/10.1111/bcp.15747
TI - Ensovibep, a SARS‐CoV‐2 antiviral DARPin, is safe and well tolerated in healthy volunteers: results of a first‐in‐human, ascending single‐dose Phase 1 study
T2 - British Journal of Clinical Pharmacology
AU - Stojcheva, Nina
AU - Gladman, Stacy
AU - Soergel, Marianne
AU - ZITT, Christof
AU - Drake, Roxana
AU - Lockett, Tony
AU - Marchand, Carine
AU - Fustier, Pierre
AU - Stavropoulou, Vaia
AU - Fernandez, Elena
AU - Pettigiani, Nathana Lopes
AU - Watkins, Kate
AU - Puri, Adeep
AU - Watson, Randall
AU - Legenne, Philippe
AU - STUMPP, Michael T.
AU - BOYCE, M. J.
PY - 2023
DA - 2023/05/08 00:00:00
PB - Wiley
SP - 2295-2303
IS - 7
VL - 89
SN - 0306-5251
SN - 1365-2125
ER -
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@article{2023_Stojcheva,
author = {Nina Stojcheva and Stacy Gladman and Marianne Soergel and Christof ZITT and Roxana Drake and Tony Lockett and Carine Marchand and Pierre Fustier and Vaia Stavropoulou and Elena Fernandez and Nathana Lopes Pettigiani and Kate Watkins and Adeep Puri and Randall Watson and Philippe Legenne and Michael T. STUMPP and M. J. BOYCE},
title = {Ensovibep, a SARS‐CoV‐2 antiviral DARPin, is safe and well tolerated in healthy volunteers: results of a first‐in‐human, ascending single‐dose Phase 1 study},
journal = {British Journal of Clinical Pharmacology},
year = {2023},
volume = {89},
publisher = {Wiley},
month = {may},
url = {https://doi.org/10.1111/bcp.15747},
number = {7},
pages = {2295--2303},
doi = {10.1111/bcp.15747}
}
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Stojcheva, Nina, et al. “Ensovibep, a SARS‐CoV‐2 antiviral DARPin, is safe and well tolerated in healthy volunteers: results of a first‐in‐human, ascending single‐dose Phase 1 study.” British Journal of Clinical Pharmacology, vol. 89, no. 7, May. 2023, pp. 2295-2303. https://doi.org/10.1111/bcp.15747.