Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CM4620-IE (Injectable Emulsion), CM-4620 Injectable Emulsion or CM-4620-IE
Auxora · 2 trials · 3 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.
Defined as the number of days hospitalized but not requiring supplemental oxygen or ongoing medical care, or; discharged and requiring supplemental oxygen, or; discharged, not requiring supplemental oxygen.
| 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. |
| Auxora (Part 1) | EXPERIMENTAL | Patients were randomized 1:1 to receive either Auxora or standard of care |
| Standard of Care (Part 1) | OTHER | Patients were randomized 1:1 to receive either Auxora or standard of care |
| Auxora (Part 2) | EXPERIMENTAL | Patients were randomized 1:1 to receive Auxora or Placebo |
| Placebo (Part 2) | PLACEBO_COMPARATOR | Patients were randomized 1:1 to receive Auxora or Placebo |
| 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. |
| Auxora (Part 1) | DRUG | Auxora will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Auxora will be administered intravenously (IV) over 4 hours. |
| Standard of Care (Part 1) | DRUG | Patients received standard of care |
| Auxora (Part 2) | DRUG | Auxora will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Auxora will be administered intravenously (IV) over 4 hours. |
| Placebo (Part 2) | DRUG | Placebo will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Placebo will be administered intravenously (IV) over 4 hours. |
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...
Top 4 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Tozorakimab |
| GSK plc Sponsored ADR | GSK | 3 | PHASE1 | Pn-MAPS30plus |
| Agenus Inc. | AGEN | 1 | PHASE2 | agenT-797 |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | V175, V175A |
Auxora is an investigational small molecule being developed for pneumonia. It has been studied in patients with severe COVID-19 pneumonia in a Phase 2 clinical trial. Auxora is not approved for commercial use and remains in clinical development.
Auxora is being developed by CalciMedica, Inc., a biopharmaceutical company that trades under the ticker symbol CALC. CalciMedica is the sponsor of the clinical program evaluating Auxora in pneumonia.
Auxora is in Phase 2 clinical development. The Phase 2 trial evaluating Auxora in severe COVID-19 pneumonia has been completed. Auxora is investigational and has not been approved by the FDA for any indication.
Auxora has been evaluated in one completed Phase 2 trial, NCT04345614, titled A Study of Auxora in Patients With Severe COVID-19 Pneumonia. The trial enrolled 314 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, Auxora (Part 1) is an alternative name for Auxora. Both names refer to the same investigational small molecule developed by CalciMedica, Inc. for pneumonia.