Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CM-4620 Injectable Emulsion or CM-4620-IE · 1 trial · 2 indications
Time to Solid Food Tolerance (TSFT): Number of hours from date/time of SFISD to date/time patient receives a solid meal that is tolerated, defined as eating \>/=50% of a low fat \>/= 500-calorie solid meal w/o increase in abdominal pain or vomiting within 2 hours of mealtime. If patient was discharged w/o tolerating solid food, the daily record of the modified ANMS Gastrointestinal Cardinal Symptom Index Daily Diary (mGCSI-DD) at or after hospital discharge was used to calculate TSFT. For these patients, TSFT date/time was considered to be 8am on the first of 3 consecutive days where the following criteria were met in mGCSI-DD: no vomiting, no or mild nausea, no or mild inability to finish a normal sized meal, no or mild abdominal pain. gMCP-Mod: Generalized Multiple Comparisons and Modeling--3 steps: 1) Hazard ratio (dose vs placebo) using stratified Cox regression w/ stratification by sex and hematocrit (high/low). 2) Multiple contrast test. 3) Find best-fit dose-response model.
| Arm | Type | Description |
|---|---|---|
| 2.0 mg/kg (1.25 mL/kg) | ACTIVE_COMPARATOR | administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses. |
| 1.0 mg/kg (0.625 mL/kg) | ACTIVE_COMPARATOR | administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses. |
| 0.5 mg/kg (0.3125 mL/kg) | ACTIVE_COMPARATOR | administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses. |
| Placebo (1.25, 0.625, or 0.3125 mL/kg) | PLACEBO_COMPARATOR | patients randomized to placebo will receive one of three following volumes (1.25 mL/kg, 0.625 mL/kg, and 0.3125 mL/kg. although three volumes - all patients randomized to placebo will be analyzed together as one arm. administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses. |
| Name | Type | Description |
|---|---|---|
| CM-4620 Injectable Emulsion or CM-4620-IE | DRUG | Auxora is to be administered as an IV infusion and is supplied as a translucent, white to yellowish colored, sterile, non-pyrogenic emulsion containing 1.6 mg/mL of the active pharmaceutical ingredient CM4620. CM4620-IE is supplied as an 80 mL fill in a 100 mL, single-use glass vial. The drug product is formulated as an emulsion due to the low solubility of CM4620 in aqueous solution. CM4620-IE contains egg phospholipids, medium chain triglycerides, glycerin, edetate disodium salt dehydrate (EDTA), sodium hydroxide (as needed to adjust pH), and sterile water for injection. |
| Placebo | OTHER | Matching Placebo is to be administered as an IV infusion and is supplied as a translucent, white to yellowish, sterile, non-pyrogenic emulsion carrier containing no active pharmaceutical ingredient. Placebo is supplied as an 80 mL fill in a 100 mL single-use vial. Placebo contains the same ingredients as Auxora except that it does not contain CM4620. |
Inclusion Criteria: All of the following must be met for a patient to be randomized into the study: 1. The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria: 1. Serum li...
CM-4620 Injectable Emulsion, also known as CM-4620-IE, is an investigational small molecule being developed for the treatment of acute pancreatitis. It is specifically studied in patients with acute pancreatitis accompanied by systemic inflammatory response syndrome (SIRS). The drug is administered as an injectable emulsion and is currently in Phase 2 clinical development.
CM-4620 is a small molecule that targets calcium release-activated calcium channels. By modulating these channels, it aims to reduce the inflammatory response associated with acute pancreatitis. The drug is designed to address the underlying pathophysiology of the condition, particularly in patients who also have systemic inflammatory response syndrome.
CM-4620 Injectable Emulsion is being developed by CalciMedica, Inc., a biopharmaceutical company. CalciMedica is publicly traded on the NASDAQ under the ticker symbol CALC. The company is focused on developing therapies that target calcium signaling pathways for the treatment of inflammatory and autoimmune diseases.
CM-4620 Injectable Emulsion is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities such as the FDA. The drug is being studied for its safety and efficacy in patients with acute pancreatitis and accompanying systemic inflammatory response syndrome.
CM-4620 Injectable Emulsion has been studied in one completed Phase 2 clinical trial with the identifier NCT04681066. The trial, titled 'A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS,' enrolled 216 participants across the United States and India. The study was randomized, double-blind, and placebo-controlled.
Yes, CM-4620 Injectable Emulsion is also known as CM-4620-IE and is referred to as Auxora in clinical trial documentation. The Phase 2 trial NCT04681066 uses the name Auxora to describe the drug. This alternative name is used interchangeably in research and development contexts.