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ensovibep

Phase 2

Covid19 | Small molecule | Infectious Disease |Molecular Partners AG|Last Updated: Sep 8, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

ensovibep · 1 trial · 1 indication

Phase 2 1
NCT04834856Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 PatientsCovid19
COMPLETED12 Analytics
PHASE2COMPLETED
Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients
Covid19Unlock trial analytics

Study Endpoints

Primary Endpoints

SARS-CoV-2 viral load
up to day 29

Changes from baseline to each time point of measurement in SARS-CoV-2 viral load in nasopharyngeal swabs

SARS-CoV-2 viral cultures
up to day 29

Changes from baseline to each time point of measurement in SARS-CoV-2 viral cultures cultivated from nasopharyngeal swabs

SARS-CoV-2 PCR days to negativity
up to day 29

Duration in days to SARS-CoV-2 PCR negativity

Observed maximum concentration (Cmax)
up to day 91

The maximum observed concentration (Cmax) is estimated based on the serum concentrations.

Terminal Elimination Half-Life (T½)
up to day 91
Time to Cmax (Tmax)
up to day 91
The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf)
up to day 91
The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
up to day 91
Apparent total body clearance of the drug from plasma (CL)
up to day 91
Apparent volume of distribution at steady state (Vss)
up to day 91

Secondary Endpoints

14 Common Covid-19 Related Symptoms score
up to day 29
Treatment-emergent (serious) adverse events ((S)AEs) and AEs of Special Interest (AESIs) including Infusion-related reactions (IRRs)
up to day 91
Concomitant medication
up to day 91
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ensovibep dose 1EXPERIMENTAL -
ensovibep dose 2EXPERIMENTAL -

Interventions

NameTypeDescription
ensovibepDRUGThe study will start with a low-dose cohort and after a safety review escalate to the higher dose cohort. One administration at day 1 by infusion.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Men or non-pregnant women, between 18 and 70 years on the day of inclusion. * Presence of one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, fatigue, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. * Posi...

Countries:Netherlands
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Frequently asked questions about ensovibep

What is ensovibep used for in Covid-19?

Ensovibep is an investigational small molecule being studied for the treatment of Covid-19. It is being developed by Molecular Partners AG (ticker: MOLN) and has completed a Phase 2 clinical trial in patients with Covid-19.

Who makes ensovibep?

Ensovibep is being developed by Molecular Partners AG, a biopharmaceutical company listed on the SIX Swiss Exchange under the ticker MOLN. The company is conducting clinical research on ensovibep as a potential treatment for Covid-19.

What phase is ensovibep in?

Ensovibep is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities. Further clinical development may be required before any potential approval.

What clinical trials is ensovibep in?

Ensovibep has been studied in one completed Phase 2 clinical trial, identified as NCT04834856, titled 'Viral Clearance, PK and Tolerability of Ensovibep in COVID-19 Patients'. This trial enrolled 12 participants in the Netherlands and was a controlled study.

Is ensovibep the same as any other drug?

Ensovibep is not known to be the same as any other drug. It is a distinct investigational small molecule being developed by Molecular Partners AG for Covid-19. No alternative names have been reported for ensovibep.