Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aztreonam for · 3 trials · 4 indications
Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an analysis of covariance (ANCOVA) model-based method.
Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by mixed-effect model repeated measures (MMRM) analysis using the ITT population analysis set.
The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Evaluable Analysis Set.
The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Sensitivity Analysis Set.
| Arm | Type | Description |
|---|---|---|
| AZLI 75 mg 3 times a day (TID) | EXPERIMENTAL | - |
| TIS 300 mg 2 times a day (BID) | ACTIVE_COMPARATOR | - |
| Aztreonam for Inhalation Solution (AZLI) | EXPERIMENTAL | Participants will receive one 28-day course of AZLI, then will be followed for a 24-week period (through Day 196). |
| AI 75 mg | EXPERIMENTAL | Aztreonam for Inhalation 75 mg twice daily |
| AI 225 mg | EXPERIMENTAL | Aztreonam for Inhalation 225 mg twice daily |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Aztreonam for Inhalation Solution (AZLI) | DRUG | Aztreonam for inhalation solution (75 mg) was administered 3 times a day (TID) for 28 days for each treatment cycle via the PARI eFlow electronic nebulizer. |
| Tobramycin Inhalation Solution (TIS) | DRUG | Tobramycin inhalation solution (300 mg) was administered 2 times a day (BID) for 28 days for each treatment cycle via the PARI LC Plus nebulizer with compressor or via another nebulizer compatible with country-specified labeling. |
| Aztreonam for Inhalation (AI) | DRUG | Aztreonam for Inhalation |
| Placebo | DRUG | Saline Placebo |
Inclusion Criteria: * Males or females aged 6 years and older * Subjects with CF as diagnosed by one of the following: documented sweat chloride \>= 60 mEq/L by quantitative pilocarpine iontophoresis test, or documented sweat sodium \>= 60 mmol/L, or 2 well characterized genetic mutations in the Cy...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | VX-121/TEZ/D-IVA |
| Sionna Therapeutics, Inc. | SION | 2 | PHASE2 | SION-719 |
| 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 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
Aztreonam for is an investigational small molecule being developed for cystic fibrosis. It is a monobactam antibiotic administered by inhalation to treat Pseudomonas aeruginosa lung infections in patients with cystic fibrosis. The drug is currently in clinical development, with completed Phase 2 and Phase 3 trials.
Aztreonam for targets Pseudomonas aeruginosa, a common bacterial pathogen that causes chronic lung infections in people with cystic fibrosis. By delivering the antibiotic directly to the lungs via inhalation, the drug aims to reduce bacterial load and improve respiratory outcomes in this patient population.
Aztreonam for is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead is conducting clinical trials to evaluate the safety and efficacy of this inhaled antibiotic for cystic fibrosis patients.
Aztreonam for has completed Phase 2 and Phase 3 clinical trials. The most advanced trial, NCT00757237, was a Phase 3 study comparing aztreonam for inhalation solution to tobramycin inhalation solution in cystic fibrosis patients with Pseudomonas aeruginosa. The drug remains investigational and is not yet approved.
Aztreonam for has been studied in three completed clinical trials. NCT00757237 was a Phase 3 trial with 274 participants comparing aztreonam to tobramycin. NCT01055847 was a Phase 2 trial with 105 participants, and NCT01375049 was a Phase 2 trial with 105 participants studying aztreonam lysine for Pseudomonas eradication.
Aztreonam for is also known as aztreonam lysine, as seen in the clinical trial NCT01375049 titled 'Aztreonam Lysine for Pseudomonas Infection Eradication Study.' The drug is formulated as an inhalation solution using the lysine salt of aztreonam to enhance solubility and delivery to the lungs.