Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD9773 · 3 trials · 2 indications
Number of ventilator-free days (VFDs)
Number of patients with treatment-emergent adverse events and number of patients who died over 28 days
Maximum concentration at steady state (Cmax ss) for serum total and specific fabs
Change in creatinine values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in alanine aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in aspartate aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in bilirubin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in haemoglobin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in white blood cell values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in platelet count values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) \[calculated as Day 28 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in prothrombin time values from baseline (pre-infusion) to Day 7 \[calculated as Day 7 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in troponin I values from baseline (pre-infusion) to Day 6 \[calculated as Day 6 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in QTcF from baseline (pre-infusion) to Day 1 (end of infusion) for Cohorts 1 and 2 \[calculated as Day 1 mean minus baseline mean\] and Day 5 (end of infusion) for Cohorts 3 to 5 and placebo \[calculated as Day 5 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in calculated mean arterial pressure from baseline (pre-infusion) to Day 14 \[calculated as Day 14 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
Change in body weight from baseline (pre-infusion) to Day 6 \[calculated as Day 6 mean minus baseline mean\]. Safety analysis set (ie all patients who started study drug infusion).
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | AZD9773 250/50 units/kg |
| 2 | EXPERIMENTAL | AZD9773 500/100 units/kg |
| 3 | PLACEBO_COMPARATOR | - |
| AZD9773 cohort 1 (50 units/kg) | EXPERIMENTAL | AZD9773: single infusion of 50 units/kg |
| AZD9773 cohort 2 (250 units/kg) | EXPERIMENTAL | AZD9773: single infusion of 250 units/kg |
| AZD9773 cohort 3 (250/50 units/kg) | EXPERIMENTAL | AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs |
| AZD9773 cohort 4 (500/100 units/kg) | EXPERIMENTAL | AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs |
| AZD9773 cohort 5 (750/250 units/kg) | EXPERIMENTAL | AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| AZD9773 | DRUG | A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days |
| Placebo | DRUG | Placebo |
| AZD9773 (CytoFab) | DRUG | intravenous infusions |
Inclusion Criteria: * Adults with a first episode of sepsis during this hospitalisation and objective evidence of infection that requires parenteral antibiotics. * At least 2 of 4 SIRS criteria in the 24 hours before organ dysfunction (must include either fever OR elevated white blood cells \[WBC\]...
AZD9773 is an investigational small molecule being developed for the treatment of severe sepsis, including septic shock. It is being studied in adult patients with these serious infectious disease conditions. The drug is administered as an intravenous infusion and is currently in clinical development, though it is not approved for use.
AZD9773 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for severe sepsis and septic shock.
AZD9773 is in Phase 2 clinical development. It has completed three Phase 2 trials, including dose escalation, safety and tolerability, and efficacy studies. The drug remains investigational and has not received regulatory approval for any use.
AZD9773 has been studied in three completed Phase 2 trials. These include NCT00615017, a dose escalation study in the United States; NCT01144624, a safety and tolerability study in Japanese patients; and NCT01145560, a placebo-controlled efficacy and safety study conducted in multiple countries. All trials enrolled patients with severe sepsis or septic shock.
Yes, AZD9773 is also known as CytoFab. This alternative name appears in the titles of two clinical trials, which refer to the drug as AZD9773 (CytoFab). The drug is being developed by AstraZeneca for severe sepsis and septic shock.