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CM4620-IE

Phase 2

Acute Pancreatitis | Small molecule | Other |CalciMedica, Inc.|Last Updated: May 3, 2022

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03709342A PK/PD Study of CM4620-IE in Patients With Acute PancreatitisPHASE2 COMPLETED 7Jan 6, 2019Jun 7, 2019May 3, 20221 United States
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Study Endpoints
Primary Endpoints
Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values
Predose to 30 minutes post dose

Outcome assessed the percent change in IL-2 production after the administration of a single dose of CM4620-IE as compared to baseline production, for all patients enrolled. This measurement was to explore if there was a change in IL-2 levels with acute pancreatitis after the administration of a single dose of CM4620-IE.

Secondary Endpoints
The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
From baseline through 30 days
Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion
Days 1, 2, 5, 10 and 30 or at discharge if earlier than day 30
Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion
Day 2
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
All PatientsEXPERIMENTAL -
Interventions
NameTypeDescription
CM4620-IEDRUGsingle IV infusion on Day 1 over 4 hours
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis, and 1 of the following 2 criteria: 1. Serum lipase and/or serum amylase \> 3 times the upper limit of normal (ULN); 2. Characteristic findings of acute pan...

Countries:United States
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