Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD1419 · 1 trial · 1 indication
LOAC was defined as any of the following: * Increase of asthma control questionnaire-5 (ACQ-5) to ≥ 1.5. * ≥ 30% reduction in morning peak expiratory flow (PEF) from baseline on 2 consecutive days. * ≥ 6 additional reliever inhalations of short-acting β agonist (SABA) in a 24-hour period relative to baseline on 2 consecutive days. * Exacerbation requiring systemic corticosteroids as decided by Investigator. Time to LOAC was calculated as start date of first LOAC - date of randomization + 1. Start date of LOAC was latest date that 1 of the 4 criteria were satisfied immediately prior to the exacerbation start date, provided no more than 7 days between LOAC and exacerbation start date. Time to LOAC was displayed using a Kaplan-Meier plot and the outcome measure is presented as number of participants with events. Cox regression analysis was used to compare treatments.
| Arm | Type | Description |
|---|---|---|
| AZD1419 | EXPERIMENTAL | Dose adaption of AZD1419, 4 mg or 8 mg or 1 mg based on occurence of AE's |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| Name | Type | Description |
|---|---|---|
| AZD1419 | DRUG | Inhaled AZD1419 administered at the clinic as once weekly inhalations with the I-neb® device. Start dose is 4 mg and dose adaptation is applied (downtitration to 1mg or uptitration to 8 mg or remain on 4 mg) based on appearance of flu like adverse events |
| Placebo | DRUG | Inhaled Placebo administered at the clinic as once weekly inhalations with the I-neb® device. Start dose is Placebo 4 mg and dose adaptation is applied (downtitration to 1mg or uptitration to 8 mg or remain on 4 mg) based on appearance of flu like adverse events |
Inclusion Criteria: * Male and female patients 18 years and above * Physician-diagnosed asthma requiring treatment with ICS and a long-acting beta agonist (LABA). Patients must have taken ICS plus LABA controller medication for at least 3 months prior to screening * Pre-bronchodilator forced expira...
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 |
AZD1419 is an investigational small molecule developed by AstraZeneca for the treatment of asthma. It has been studied in a Phase 2a clinical trial in adults with asthma. It is not approved for any indication and remains in clinical development.
AZD1419 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating AZD1419 in asthma.
AZD1419 has completed a Phase 2a clinical trial in asthma. It is an investigational agent and has not been approved by the FDA or any other regulatory authority for marketing. Further development status beyond this completed Phase 2a study is not established.
AZD1419 has been evaluated in one completed Phase 2a trial, NCT02898662, titled AZD1419 Ph2a Study. The trial enrolled 81 adults with asthma across Denmark, Hungary, Poland, and Sweden. It was randomized, double-blind, and placebo-controlled.
Yes. The Phase 2a trial of AZD1419, NCT02898662, was a randomized, double-blind, placebo-controlled study. It enrolled 81 participants with asthma aged 18 years and older, across sites in Denmark, Hungary, Poland, and Sweden. The trial is completed.
Yes. The clinical program for AZD1419 in asthma has used a biomarker-selected approach, meaning trial enrollment was guided by a biomarker. The Phase 2a study NCT02898662 enrolled 81 adults with asthma and was randomized, double-blind, and placebo-controlled.