Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZLI two times a day/three times a day · 2 trials · 1 indication
Participants experiencing at least 1 treatment-emergent AE or at least 1 serious adverse event (SAE) were summarized for the study as a whole. A treatment-emergent AE was any physical or clinical worsening in symptoms or disease experienced by the participant, whether or not the event was considered related to study participation or study procedures. An SAE was any adverse experience that resulted in hospitalization or death. Participants were monitored for AEs and SAEs during all on-treatment and off-treatment intervals throughout the 18-month study period.
Airway reactivity (percent change in FEV1 from pretreatment to 30 minutes after treatment with AZLI) was assessed at all study visits in which a participant received AZLI treatment. A participant was included in this endpoint if they experienced a decline in FEV1 of ≥15% at any visit in which they received AZLI.
HR was recorded at all visits. Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.
BP was recorded at all visits. Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.
Temperature was recorded at all visits. Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.
RR was recorded at all visits. Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.
The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other.
| Arm | Type | Description |
|---|---|---|
| Placebo (pooled two times a day [BID]/three times a day [TID]) | PLACEBO_COMPARATOR | - |
| AZLI (pooled two times a day [BID]/three times a day [TID]) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AZLI 75 mg two times a day (BID)/ three times a day (TID) | DRUG | - |
| AZLI 75 mg two times a day (BID)/three times a day (TID) | DRUG | - |
| Placebo two times a day (BID)/three times a day (TID) | DRUG | - |
Inclusion Criteria: * Compliance with Studies CP-AI-005 (NCT00104520) or CP-AI-007 (NCT00112359) by taking at least 50% of expected study medication. * Completion of CP-AI-005 or CP-AI-007 or was withdrawn due to need for antipseudomonal antibiotics or for an AE unrelated to study medication tolera...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-272, Tezacaftor |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
AZLI two times a day/three times a day is an inhaled treatment studied for cystic fibrosis in patients with Pseudomonas aeruginosa infection. It is a small molecule formulation of aztreonam for inhalation solution, evaluated in Phase 3 trials in this respiratory indication. It is not described as approved and remains an investigational asset.
AZLI two times a day/three times a day is being developed by Gilead Sciences, Inc., which trades on Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical program evaluating this inhaled cystic fibrosis treatment.
AZLI two times a day/three times a day is in Phase 3 development. Two Phase 3 trials have been completed, and no trials are currently active. The program is investigational and has not been described as approved by the FDA.
AZLI two times a day/three times a day has been studied in two completed Phase 3 trials. NCT00128492 enrolled 274 cystic fibrosis patients with Pseudomonas aeruginosa across the United States, Australia, Canada, and New Zealand. NCT00104520 enrolled 211 patients in the United States. Both trials included patients aged 6 years and older.
AZLI two times a day/three times a day was evaluated in two completed Phase 3 trials that were randomized, double blind, and placebo controlled. Together the trials enrolled 485 cystic fibrosis patients with Pseudomonas aeruginosa infection. Both studies required participants to be at least 6 years old and enrolled both sexes.