Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD9773 (CytoFab), CytoFab™
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 was developed for the treatment of severe sepsis and septic shock in adult patients. It was studied as an intravenous infusion in hospitalized adults with these serious systemic inflammatory conditions. All three of its clinical trials enrolled patients with severe sepsis or septic shock, and the program is no longer active.
AZD9773 was developed by AstraZeneca PLC, which trades on the New York Stock Exchange under the ticker AZN. AstraZeneca sponsored the clinical program evaluating the drug in severe sepsis and septic shock, including trials conducted in North America, Europe, Japan, and Australia.
AZD9773 is a Phase 2 investigational agent that is no longer in active clinical development. Three Phase 2 trials were completed, and no trials are currently recruiting or ongoing. The studies together enrolled approximately 390 patients with severe sepsis or septic shock.
AZD9773 was evaluated in three completed Phase 2 trials. NCT01145560 compared two dosing regimens of intravenous AZD9773 with placebo in 300 adults with severe sepsis or septic shock across seven countries. NCT01144624 assessed two doses in 20 Japanese patients, and NCT00615017 was a dose escalation study in 70 patients in the United States.
Yes, AZD9773 is also known as CytoFab. CytoFab is the alternative name used for the same investigational compound in study titles and publications. Both names refer to the AstraZeneca Phase 2 candidate studied in severe sepsis and septic shock.
AZD9773 was given as an intravenous infusion in its clinical trials. The Phase 2 studies used randomized, double-blind, placebo-controlled designs, and NCT01145560 specifically compared two different dosing regimens of intravenous AZD9773 infusions against placebo in adults with severe sepsis or septic shock.