Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD1981 · 7 trials · 6 indications
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Each subscore measured on scale 1 (normal) to 5 (worst outcome). Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome). Change from baseline.
Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
Change in Induced sputum Eosinophil count (% of total) from baseline
Change in Induced sputum Neutrophils count (% of total) from baseline
Change in Induced sputum Macrophages count (% of total) from baseline
Change in Induced sputum Lymphocytes count (% of total) from baseline
Change in Induced sputum Epithelial cells count (% of total) from baseline
Change in Induced sputum Total cells count from baseline
Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)
Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)
Mean change in Total CCQ from baseline to Week 4 (last measurement post dose used, if data missing). Scores for total CCQ range from 0 (low symptoms) to 6 (high symptoms).
| Arm | Type | Description |
|---|---|---|
| AZD1981 10 mg | EXPERIMENTAL | AZD1981 10 mg |
| AZD1981 40 mg | EXPERIMENTAL | AZD1981 40 mg |
| AZD1981 100 mg | EXPERIMENTAL | AZD1981 100 mg |
| AZD1981 400 mg | EXPERIMENTAL | AZD1981 400 mg |
| AZD1981 80 mg | EXPERIMENTAL | AZD1981 80 mg |
| AZD1981 200 mg | EXPERIMENTAL | AZD1981 200 mg |
| Placebo | PLACEBO_COMPARATOR | - |
| AZD1981 | EXPERIMENTAL | - |
| AZD1981 50 mg | EXPERIMENTAL | AZD1981 50 mg Twice Daily (Bid) |
| AZD1981 1000 mg | EXPERIMENTAL | AZD1981 1000 mg Twice Daily (Bid) |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AZD1981 | DRUG | AZD1981 twice daily |
| Placebo | DRUG | Placebo to match AZD1981 |
| pravastatin | DRUG | 40 mg, once daily at Day 1, period A and Day 8, period B |
| AZD1981, 2000mg | DRUG | Single oral dose, tablets |
| AZD1981, 200mg | DRUG | Single oral dose, tablets |
| Moxifloxacin, 400mg | DRUG | Single oral dose, capsule |
| Neovletta 21/28 | DRUG | Once daily with (21) or without (28) pause for bleeding. |
| Placebo AZD1981 | DRUG | 4X100 mg per oral, twice daily for 28 days |
Inclusion Criteria: * Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception * 6 months history of asthma according to ATS definition * Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2 * Pre-bronchodilator FEV1 of 40 ...
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AZD1981 is an investigational oral small molecule developed for respiratory conditions, specifically asthma and chronic obstructive pulmonary disease (COPD). It has been studied in asthma patients and in moderate to severe COPD, as well as in drug interaction studies involving pravastatin and oral contraceptives. It is not approved for any indication.
AZD1981 targets PTGDR2, also known as CRTH2, a prostaglandin D2 receptor. It acts as an antagonist, blocking the receptor. This mechanism is intended to reduce inflammatory responses in airway diseases such as asthma and COPD.
AZD1981 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical trials evaluating the drug.
AZD1981 is in Phase 2 clinical development. The Phase 2 trial, NCT01197794, evaluated once and twice daily doses in asthmatic patients and has been completed. Additional Phase 1 trials have also been completed. The drug is investigational and has not been approved by the FDA.
AZD1981 has been studied in four completed trials: NCT01197794, a Phase 2 efficacy and safety trial in 1,144 asthma patients; NCT01265641, a Phase 1 QT interval study in 44 healthy males; NCT01254461, a Phase 1 drug interaction study with pravastatin in 30 healthy males; and NCT01110525, a Phase 1 interaction study with oral contraceptives in 28 healthy females.