Trial Outcomes & Findings for A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis (NCT NCT03709342)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Predose to 30 minutes post dose

Results posted on

2022-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients CM4620-IE: single IV infusion on Day 1 over 4 hours
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=7 Participants CM4620-IE: single IV infusion on Day 1 over 4 hours
Age, Continuous	42 years STANDARD_DEVIATION 8.7 • n=39 Participants
Sex: Female, Male Female	2 Participants n=39 Participants
Sex: Female, Male Male	5 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	4 Participants n=39 Participants
Race (NIH/OMB) White	3 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	7 participants n=39 Participants

PRIMARY outcome

Timeframe: Predose to 30 minutes post dose

Population: The final analysis set consisted of pre-dose to Discharge samples for 4 patients, due to logistical issues in timely assaying of the samples.

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.

Outcome measures

Outcome measures
Measure	All Patients n=4 Participants CM4620-IE: single IV infusion on Day 1 over 4 hours
Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values	-55.5 percentage of change in IL-2 production Standard Error 5.8

SECONDARY outcome

Timeframe: From baseline through 30 days

The number of participants who experienced treatment-emergent adverse events (TEAEs) with Investigator-specified relationship to CM4620-IE and assessment of severity.

Outcome measures

Outcome measures
Measure	All Patients n=7 Participants CM4620-IE: single IV infusion on Day 1 over 4 hours
The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	3 Participants

SECONDARY outcome

Timeframe: Days 1, 2, 5, 10 and 30 or at discharge if earlier than day 30

Outcome measures

Outcome measures
Measure	All Patients n=7 Participants CM4620-IE: single IV infusion on Day 1 over 4 hours
Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion	791 Nanograms/mL Geometric Coefficient of Variation 47

SECONDARY outcome

Timeframe: Day 2

Population: Samples were only received for analysis for 5 patients for day 2

Time points for sampling of plasma for bioanalysis of CM4620, blood for PD analysis (stimulated IL-2 release), and serum for cytokine analysis were chosen to capture the expected maximal plasma concentration (Cmax) on Day 1 and times close to the minimum plasma concentration (Cmin) on subsequent days.

Outcome measures

Outcome measures
Measure	All Patients n=5 Participants CM4620-IE: single IV infusion on Day 1 over 4 hours
Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion	109 Ng/mL Geometric Coefficient of Variation 49

SECONDARY outcome

Timeframe: Day 10, or day of discharge

Outcome measures

Outcome measures
Measure	All Patients n=7 Participants CM4620-IE: single IV infusion on Day 1 over 4 hours
Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge	76 Ng/mL Geometric Coefficient of Variation 46

SECONDARY outcome

Timeframe: Day 30

Outcome measures

Outcome measures
Measure	All Patients n=7 Participants CM4620-IE: single IV infusion on Day 1 over 4 hours
Pharmacokinetics (Plasma Concentration of CM4620): Day 30	56 Ng/mL Geometric Coefficient of Variation 32

SECONDARY outcome

Timeframe: Baseline

Included plasma samples collected 1 hour prior to the study drug administration

Outcome measures

Outcome measures
Measure	All Patients n=7 Participants CM4620-IE: single IV infusion on Day 1 over 4 hours
Baseline Levels of IL-6	46.04 pg/mL Standard Error 26.3

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	All Patients n=7 Participants CM4620-IE: single IV infusion on Day 1 over 4 hours
Day 1: 30 Minutes Post-infusion IL-6 Levels	40.83 pg/mL Standard Error 23.29

SECONDARY outcome

Timeframe: Day 2

Outcome measures

Outcome measures
Measure	All Patients n=6 Participants CM4620-IE: single IV infusion on Day 1 over 4 hours
Day 2: 20-hr Post Infusion IL-6 Levels	24.8 pg/mL Standard Error 12.4

SECONDARY outcome

Timeframe: Assessed at Discharge, between 2 and 9 days.

This sample was drawn immediately prior to discharge from hospitalization, and ranged from day 2 through day 9.

Outcome measures

Outcome measures
Measure	All Patients n=7 Participants CM4620-IE: single IV infusion on Day 1 over 4 hours
Post-infusion IL-6 Levels at Discharge	13.9 pg/mL Standard Error 2.0

Adverse Events

All Patients

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Patients n=7 participants at risk CM4620-IE: single IV infusion on Day 1 over 4 hours
Gastrointestinal disorders Acute Pancreatitis	14.3% 1/7 • Number of events 1 • Adverse event data were collected over 90 days per subject, from the start of dosing until the 30-day follow-up.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	14.3% 1/7 • Number of events 1 • Adverse event data were collected over 90 days per subject, from the start of dosing until the 30-day follow-up.

Other adverse events

Other adverse events
Measure	All Patients n=7 participants at risk CM4620-IE: single IV infusion on Day 1 over 4 hours
Gastrointestinal disorders Melaena	14.3% 1/7 • Number of events 1 • Adverse event data were collected over 90 days per subject, from the start of dosing until the 30-day follow-up.
Skin and subcutaneous tissue disorders Bursitis	14.3% 1/7 • Number of events 1 • Adverse event data were collected over 90 days per subject, from the start of dosing until the 30-day follow-up.
Gastrointestinal disorders Acute Pancreatitis	14.3% 1/7 • Number of events 1 • Adverse event data were collected over 90 days per subject, from the start of dosing until the 30-day follow-up.
Respiratory, thoracic and mediastinal disorders Pneumonia	14.3% 1/7 • Number of events 1 • Adverse event data were collected over 90 days per subject, from the start of dosing until the 30-day follow-up.
General disorders Alcohol Withdrawal Syndrome	14.3% 1/7 • Number of events 1 • Adverse event data were collected over 90 days per subject, from the start of dosing until the 30-day follow-up.
General disorders Pyrexia	14.3% 1/7 • Number of events 1 • Adverse event data were collected over 90 days per subject, from the start of dosing until the 30-day follow-up.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	14.3% 1/7 • Number of events 1 • Adverse event data were collected over 90 days per subject, from the start of dosing until the 30-day follow-up.

Additional Information

Sudarshan Hebbar, MD

CalciMedica

Phone: 816-838-7105

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place