Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Bretzri, BGF
Breztri · 3 trials · 2 indications
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary outcomes.
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. Treatment policy was implemented to handle all intercurrent events (ICEs) with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
| Arm | Type | Description |
|---|---|---|
| BGF arm | EXPERIMENTAL | BGF MDI 320/14.4/9.6 μg BID |
| GFF arm | EXPERIMENTAL | GFF MDI 14.4/9.6 μg BID |
| Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg | EXPERIMENTAL | BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) |
| BGF MDI 320/14.4/9.6 μg | EXPERIMENTAL | BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) |
| Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg | ACTIVE_COMPARATOR | BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI) |
| Symbicort® | ACTIVE_COMPARATOR | Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg |
| Name | Type | Description |
|---|---|---|
| BGF MDI 320/14.4/9.6 μg | DRUG | Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension |
| GFF MDI 14.4/9.6 μg | DRUG | Glycopyrronium and formoterol fumarate pressurized inhalation suspension |
| BGF MDI 320/28.8/9.6 μg | DRUG | Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler |
| BFF MDI 320/9.6 μg | DRUG | Budesonide and formoterol fumarate metered dose inhaler |
| BFF pMDI 320/9 μg | DRUG | Budesonide/formoterol fumarate pressurized metered dose inhaler |
Inclusion Criteria: 1. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing the ICF. 2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2) 3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70% ...
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 | 29 | 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 |
Breztri is used to treat chronic obstructive pulmonary disease (COPD) and asthma. It is a small molecule inhaled therapy developed by AstraZeneca for these respiratory conditions. The COPD program is in Phase 3, and the asthma program has been studied in completed Phase 3 trials in adults and adolescents with inadequately controlled disease.
Breztri is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical trials evaluating the therapy in COPD and asthma.
Breztri is in Phase 3 clinical development. One Phase 3 trial in COPD is currently recruiting, while two Phase 3 asthma trials have been completed. The program has enrolled approximately 5,250 participants across its trials.
Breztri has been studied in Phase 3 trials including NCT06283966, a recruiting COPD study evaluating cardiopulmonary outcomes with planned enrollment of 5,250 participants. Completed asthma trials include NCT04609904 (LOGOS) with 2,187 participants and NCT04609878 (KALOS) with 2,274 participants, both in adults and adolescents with inadequately controlled asthma.
Yes. Breztri is also known as Bretzri and as BGF MDI, with the dose strengths BGF MDI 320/28.8/9.6 micrograms and BGF MDI 320/14.4/9.6 micrograms. These names refer to the same AstraZeneca inhaled therapy, which is also referred to as PT010 in its clinical trials.
Breztri is used for chronic obstructive pulmonary disease, or COPD. A Phase 3 trial, NCT06283966, is evaluating the metered dose inhaler on cardiopulmonary outcomes in COPD. That study is recruiting participants aged 40 years and older across numerous countries, with a planned enrollment of 5,250.