Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FTI, AZLI · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| FTI 80mg/20mg BID | EXPERIMENTAL | Fosfomycin/Tobramycin combination 80mg/20 mg inhaled twice daily |
| FTI 160mg/40mg BID | EXPERIMENTAL | Fosfomycin/Tobramycin combination 160 mg/40 mg inhaled twice daily |
| Placebo A BID | PLACEBO_COMPARATOR | Placebo A inhaled twice daily |
| Placebo B BID | PLACEBO_COMPARATOR | Placebo B inhaled twice daily |
| Name | Type | Description |
|---|---|---|
| FTI, AZLI | DRUG | Evaluation of 2 dosage combinations of fosfomycin and tobramycin inhaled twice daily for 28 days following 28 days of inhaled AZLI (Aztreonam Lysine for Inhalation) |
| Placebo, AZLI | DRUG | Volume-matched placebo inhaled twice daily for 28 days following 28 days of AZLI (Aztreonam Lysine for Inhalation). |
Inclusion Criteria: * Males or females aged 18 years and older * Patients with CF as diagnosed by one of the following: * Documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test, OR * Documented sweat sodium greater than or equal to 60 mmol/L,...
| 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 |
FTI, AZLI is an investigational small molecule being developed for the treatment of Cystic Fibrosis. It is being studied in patients with Cystic Fibrosis who have a Pseudomonas aeruginosa lung infection. The drug is administered via inhalation and is currently in Phase 2 clinical development.
FTI, AZLI is a combination of fosfomycin and tobramycin for inhalation. Fosfomycin and tobramycin are antibiotics that target Pseudomonas aeruginosa, a common bacterial pathogen in Cystic Fibrosis patients. The drug is designed to deliver both antibiotics directly to the lungs to treat the infection.
FTI, AZLI is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead Sciences is responsible for the clinical development and potential commercialization of this investigational drug for Cystic Fibrosis.
FTI, AZLI is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate its safety and efficacy in patients with Cystic Fibrosis and Pseudomonas aeruginosa lung infection.
FTI, AZLI has been studied in one completed Phase 2 clinical trial with the identifier NCT00794586. The trial was a randomized, double-blind, placebo-controlled study that enrolled 120 participants in the United States. The study evaluated fosfomycin/tobramycin for inhalation in Cystic Fibrosis patients with Pseudomonas aeruginosa lung infection.
Yes, FTI, AZLI is the same as fosfomycin/tobramycin for inhalation. The drug is a combination of the antibiotics fosfomycin and tobramycin, administered via inhalation. It is being developed for the treatment of Cystic Fibrosis patients with Pseudomonas aeruginosa lung infection.