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CM4620-IE

Phase 2

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

CM4620-IE development status

Highest phase Phase 2
Registered trials 2 across 2 sponsors since Oct 2018

CM4620-IE target and mechanism

Molecular targetOrai1
Target classCrac Channel
ModalitySmall molecule

Also known as CM4620

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

CM4620-IE clinical trials

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 PancreatitisUnlock trial analytics

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?

CM4620-IE is an investigational small molecule developed by CalciMedica, Inc. (ticker CALC) for acute pancreatitis. It is a Phase 2 drug candidate and has been studied in a completed clinical trial. It is not described as approved, so it remains in clinical development.

What is CM4620-IE used for in acute pancreatitis?

CM4620-IE is being developed for the treatment of acute pancreatitis, a gastrointestinal condition. CalciMedica, Inc. is studying it in this indication. The program has completed a Phase 2 trial, and the drug is investigational rather than an approved therapy for acute pancreatitis.

What does CM4620-IE target?

CM4620-IE targets Orai1, a component of the CRAC channel, which is a calcium release-activated calcium channel. By acting on this target class, the small molecule is designed to modulate CRAC channel activity. CalciMedica, Inc. is developing CM4620-IE around this mechanism for acute pancreatitis.

Who is developing CM4620-IE?

CM4620-IE is being developed by CalciMedica, Inc., which trades under the ticker CALC. The company is the sponsor of the clinical program for this small molecule in acute pancreatitis. No other developer or partnership is associated with the asset in the available program information.

What phase is CM4620-IE in?

CM4620-IE is in Phase 2 development. Its single clinical trial, NCT03709342, was a Phase 2 PK/PD study in patients with acute pancreatitis that has been completed. The drug is investigational and is not described as FDA approved.

What clinical trials is CM4620-IE in?

CM4620-IE has been studied in one clinical trial, NCT03709342, titled A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis. It was a completed Phase 2 study conducted in the United States with 7 enrolled patients, ages 18 years and older, and it was uncontrolled.