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CM4620 Injectable Emulsion · 1 trial · 2 indications
Safety and tolerability will be assessed by monitoring the frequency, duration and severity of treatment-emergent adverse events (TEAEs) throughout the study period.
| Arm | Type | Description |
|---|---|---|
| Low Dose Group | EXPERIMENTAL | Phase 1: Cohorts 1 \& 2 will consist of 4 female and 4 male patients enrolled concurrently who will be randomized 3:1 to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for patients who are randomized to receive CM4620-IE are 1.0 mg/kg on Days 1 and 1.4 mg/kg on Days 2-4. |
| High Dose Group | EXPERIMENTAL | Phase 2: Cohorts 3 \& 4 will consist of 8 female and 8 male patients enrolled concurrently who will be randomized 3:1 to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for patients who are randomized to receive CM4620-IE are 2.08 mg/kg of CM4620-IE on Days 1 and 2, and 1.6 mg/kg on Days 3 and 4. |
| Standard of Care | NO_INTERVENTION | For all cohorts, patients will be randomized 3:1 to CM4620-IE plus standard of care versus standard of care alone. |
| Name | Type | Description |
|---|---|---|
| CM4620 Injectable Emulsion (Low Dose) | DRUG | CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2-4, during the first phase of the study (Cohorts 1 and 2). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours. |
| CM4620 Injectable Emulsion (High Dose) | DRUG | CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4, during the second phase of the study (Cohorts 3 and 4). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours. |
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 panc...
CM4620 Injectable Emulsion is an investigational small molecule being developed for acute pancreatitis. It is studied in patients with acute pancreatitis and systemic inflammatory response syndrome (SIRS). The drug is administered as an injectable emulsion and is currently in Phase 2 clinical development.
CM4620 Injectable Emulsion is being developed by CalciMedica, Inc., a biopharmaceutical company traded on the stock exchange under the ticker CALC. The company is conducting clinical research on this drug for the treatment of acute pancreatitis.
CM4620 Injectable Emulsion is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and efficacy for acute pancreatitis.
CM4620 Injectable Emulsion has one completed Phase 2 clinical trial with the identifier NCT03401190. The trial, titled "CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS," enrolled 21 participants in the United States and was completed.
CM4620 Injectable Emulsion is the formulation name of the drug CM4620. The clinical trial NCT03401190 refers to the drug as CM4620 Injectable Emulsion, indicating that this is the specific dosage form being tested in patients with acute pancreatitis.