Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Auxora · 2 trials · 2 indications
The primary efficacy analysis will apply the win ratio method and the Finkelstein-Schoenfeld method to the primary endpoints. The win ratio method allocates all Auxora and placebo pairs to the components that comprise the primary endpoint in a hierarchical fashion. Categories (a) and (c) represent Auxora wins based on all-cause mortality and days ventilator-free and KRT-free. Similarly, categories (b) and (d) represent placebo wins. Category (e) represents ties. (a) Death on placebo, but alive on Auxora at day 30 (b) Death on Auxora, but alive on placebo at day 30 (e) Death on placebo and death on Auxora at day 30 If alive on placebo and alive on Auxora at day 30: (c) Greater number of days alive, ventilator-free and KRT-free on Auxora (d) Greater number of days alive, ventilator-free and KRT-free on Placebo (e) Equal number of days alive, ventilator-free and KRT-free We will calculate the overall win ratio by adding (a) + (c) and dividing it by the sum of (b) + (d).
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 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 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 | DRUG | 1.25 mL/kg (2.0 mg/kg of zegocractin) intravenously (IV) over 4 hours at 0 hours, and then 1.0 mL/kg (1.6 mg/kg of zegocractin) IV over 4 hours at 24, 48, 72 and 96 hours for a total of 5 doses. |
| Placebo | DRUG | 1.25 mL/kg IV over 4 hours at 0 hours and then 1.0 mL/kg IV over 4 hours at 24, 48, 72, and 96 hours for a total of 5 doses. |
| 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: 1. The patient is ≥ 18 years of age. 2. The patient has developed Stage 2 or Stage 3 AKI. 3. The patient has a documented partial pressure of oxygen \[Pa02\]/fraction of inspired oxygen \[FiO2\] (P/F) ≤ 300 in the prior 24 hours, either imputed from SpO2 or obtained from an arte...
| 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 |
| Co-Diagnostics, Inc. | CODX | 1 | - | Undisclosed |