Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C] AZD5069
AZD5069 · 7 trials · 16 indications
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Adverse event (AE) data, both serious and non-serious. An AE is the development of an undesirable medical condition (eg, nausea, chest pain, tachycardia, laboratory findings) or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
Physical examination includes assessment of general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, musculo-skeletal (including spine and extremities), cardiovascular, lungs and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.
ECGs were recorded in the supine position after the patient has rested for 10 minutes. Heart rate, QRS duration, PR, RR and QT intervals were recorded. Overall evaluation of the ECG is classified as normal, abnormal or borderline. Only participants with ECG at baseline classified as normal are reported (ie, only changes from normal to abnormal).
The change in circulating leucocyte counts (including neutrophils) is calculated as the End of Treatment value minus the Baseline value.
The change in body temperature (oral) is calculated as the End of Treatment value minus the Baseline value.
The change in systolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
The change in diastolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
The change in pulse rate (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
The change in FEV1 Pre-bronchodilator is calculated as the End of Treatment value minus the Baseline value.
The change in FEV1 Post-bronchodilator is calculated as the End of Treatment value minus the Baseline value.
High Transaminase Values are defined as a measurment of ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than or equal to 3 times the upper limit of normal (ALT ULN = 36 IU/L, AST ULN = 33 IU/L).
The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.
Change from baseline reflects the Week 4 value minus the baseline value. Baseline value is Day-14 measurement. For semi-quantitative scores, 1= few number of Neutrophils, 2= moderate number of Neutrophils, 3= abundant of Neutrophils. For this end point the reduction in mean of semi-quantitative (arbitrary) scores indicates better result, i.e. lower numbers of Neutrophils. The scores given for the biopsies taken at screening and end of treatment is the mean global semi-quantitative scores for the three compartments intraepithelial, subepithelial and submucosal.
Change from Baseline reflects the Day 8, Day22 and Day29 minus the baseline value.
Change from Baseline reflects the Day 2, Day 8, Day 15, Day 22, Day29 and Day 34 minus the baseline value
(AUC(0-t)) area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, (Cmax) observed maximum plasma concentration, (λz) terminal rate constant, (t½λz) terminal half-life, (tmax) time to reach maximum plasma concentration (tmax), (CL/F) apparent oral clearance (AZD5069 only), (Vz/F) apparent volume of distribution.
| Arm | Type | Description |
|---|---|---|
| AZD5069 5 mg | EXPERIMENTAL | AZD5069 oral capsules self-administered twice daily |
| AZD5069 15 mg | EXPERIMENTAL | AZD5069 oral capsules self-administered twice daily |
| AZD5069 45 mg | EXPERIMENTAL | AZD5069 oral capsules self-administered twice daily |
| Placebo | PLACEBO_COMPARATOR | Placebo oral capsules self-administered twice daily |
| 1 | EXPERIMENTAL | Treatment arm AZD5069 |
| 2 | PLACEBO_COMPARATOR | Placebo dose. |
| 3 | EXPERIMENTAL | Treatment arm AZD5069 80mg |
| First AZD5069, then Ketoconazole + AZD5069 | EXPERIMENTAL | AZD5069 in first period (on 1 day) and in second period (after wash out) ketoconazole alone (on 2 days) then ketoconazole + AZD5069 (on 1 day), then again ketoconazole alone (on 2 days) |
| Name | Type | Description |
|---|---|---|
| AZD5069 | DRUG | AZD5069 oral capsules self-administered twice daily. |
| Placebo | DRUG | Placebo oral capsules self-administered twice daily. |
| AZD5069 50mg | DRUG | Oral dose bid |
| AZD5069 80mg | DRUG | Oral dose bid |
| Ketoconazole | DRUG | Ketoconazole 400 mg (2x200 mg tablets) |
| 100 mg (50 mg x 2) AZD5069 | DRUG | Twice daily for 7 days |
| 100 mg Placebo | DRUG | Twice daily for 7 days |
Inclusion Criteria: * Men and women aged 18 years and above. Females of childbearing potential must use a highly effective contraceptive method plus a condom by their male partner. * Diagnosis of asthma for at least 12 months (GINA 2011) * Uncontrolled persistent asthma, despite treatment with medi...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
AZD5069 is an investigational small molecule developed for respiratory conditions, including asthma, bronchiectasis, and chronic obstructive pulmonary disease (COPD). It has been studied in clinical trials for patients with uncontrolled persistent asthma. AZD5069 is not approved for any indication and remains in clinical development.
AZD5069 targets the chemokine receptor 2 (CXCR2). It acts as a CXCR2 antagonist, a class of compounds that modulate neutrophil function. This mechanism is being explored in inflammatory respiratory diseases such as asthma and COPD.
AZD5069 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical trials evaluating AZD5069 in respiratory indications.
AZD5069 is in Phase 2 clinical development. The Phase 2 trial, NCT01704495, evaluated AZD5069 in patients with uncontrolled persistent asthma. The drug is investigational and has not been approved by the FDA or any regulatory agency.
AZD5069 has been studied in completed trials including NCT01704495, a Phase 2 trial in uncontrolled persistent asthma with 1,147 participants; NCT01890148, a Phase 1 asthma study; NCT01735240, a Phase 1 pharmacokinetic study; and NCT01480739, a Phase 1 neutrophil function study.