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MP0420

Phase 3

COVID-19 | Small molecule | Infectious Disease |Molecular Partners AG|Last Updated: Feb 5, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment485
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05780463MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)PHASE3 COMPLETED 485Jun 11, 2021Jun 8, 2023Feb 5, 2024105 United States, Denmark +8
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Study Endpoints
Primary Endpoints
Number of Participants With Sustained Recovery
Through Day 90

Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.

Number of Participants With an Ordinal Outcome on Day 5
Status on Day 5

Ordinal outcome with 7 mutually exclusive categories

Secondary Endpoints
Number of Participants Who Died From All Causes
Through Day 90
Number of Participants With a Safety Outcome Through Day 5
Through Day 5
Number of Participants With a Safety Outcome Through Day 28
Through Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MP0420 plus SOCEXPERIMENTAL* MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo plus SOCPLACEBO_COMPARATOR* Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Interventions
NameTypeDescription
MP0420DRUGMP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains.
PlaceboDRUGCommercially available 0.9% sodium chloride solution
RemdesivirBIOLOGICALAntiviral agent
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites105

Inclusion Criteria: Refer to the master protocol (NCT04501978) Exclusion Criteria: Refer to the master protocol (NCT04501978) Additional Exclusion Criteria: 1. Pregnant women 2. Nursing mothers 3. Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from ...

Countries:United StatesDenmarkGreeceNigeriaPolandSingaporeSpainSwitzerlandUgandaUnited Kingdom
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