Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00794586 | Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection | PHASE2 | COMPLETED | 120 | — | — | Nov 1, 2008 | Mar 1, 2010 | Dec 27, 2013 | 36 | United States |
| 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 | 9 | PHASE3 | VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA, VNZ/TEZ/D-IVA, VX-522 mRNA therapy |
| Sionna Therapeutics, Inc. | SION | 2 | PHASE2 | SION-719, SION-451, SION-2222, SION-109 |
| BiomX Ltd | 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 |