Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Auxora · 1 trial · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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. |
Part 1: Inclusion Criteria 1. 1\. The diagnosis of COVID-19 established standard RT-PCR assay; 2. At least 1 of the following symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; 3. At least 1 of the followin...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Tozorakimab |
| GSK plc Sponsored ADR | GSK | 3 | PHASE1 | Pn-MAPS30plus, PCV20 |
| Pfizer Inc. | PFE | 4 | - | Undisclosed |
| Sanofi SA Sponsored ADR | SNY | 1 | - | Undisclosed |
| Gilead Sciences, Inc. | GILD | 1 | - | Undisclosed |
| Grace Therapeutics, Inc. | GRCE | 1 | N/A | Undisclosed |
Auxora is an investigational small molecule being studied for acute kidney injury and pneumonia. It has been evaluated in patients with severe COVID-19 pneumonia and in patients with acute kidney injury and injurious lung crosstalk. Auxora is not approved and remains in clinical development.
Auxora is being developed by CalciMedica, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol CALC. The company is conducting clinical trials of Auxora in the United States.
Auxora is in Phase 2 clinical development. It has been studied in Phase 2 trials for severe COVID-19 pneumonia and for acute kidney injury. Auxora is an investigational drug and has not been approved by regulatory authorities.
Auxora has been studied in two Phase 2 clinical trials. NCT04345614 evaluated Auxora in patients with severe COVID-19 pneumonia and was completed with 314 participants. NCT06374797 evaluated Auxora in patients with acute kidney injury and injurious lung crosstalk, enrolling 122 participants.
Auxora is also known as CM4620. It is a small molecule being developed by CalciMedica for acute kidney injury and pneumonia. The drug has been tested in clinical trials under the name Auxora.