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CM4620-IE

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

CM4620-IE · 1 trial · 1 indication

Phase 2 1
NCT03709342A PK/PD Study of CM4620-IE in Patients With Acute PancreatitisAcute Pancreatitis
COMPLETED7 Analytics
PHASE2COMPLETED
A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis
Acute Pancreatitis
NCT037093427
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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 to 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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Frequently asked questions about CM4620-IE

What is CM4620-IE used for?

CM4620-IE is an investigational small molecule being developed for the treatment of acute pancreatitis. It is currently in Phase 2 clinical development and has been studied in patients with this condition. The drug is not yet approved and remains under investigation.

Who makes CM4620-IE?

CM4620-IE is being developed by CalciMedica, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol CALC. CalciMedica is responsible for the clinical development of this investigational drug for acute pancreatitis.

What phase is CM4620-IE in?

CM4620-IE is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a pharmacokinetic and pharmacodynamic study in patients with acute pancreatitis. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials has CM4620-IE been in?

CM4620-IE has been studied in one completed Phase 2 clinical trial, identified as NCT03709342. This trial was a PK/PD study in patients with acute pancreatitis, conducted in the United States. The study enrolled 7 participants aged 18 years and older.

Is CM4620-IE the same as any other drug?

CM4620-IE is the primary name used for this investigational drug. No alternative names have been reported for this compound. It is being developed specifically for acute pancreatitis and is not known to be marketed under any other designation.