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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00934362 | Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease | PHASE2 | COMPLETED | 16 | — | — | Oct 1, 2008 | Aug 1, 2010 | Mar 13, 2017 | 1 | United States |
Clearance of radiolabeled particles, following inhalation, are followed over time. Average clearance rate through 60 minutes post inhaled isotope deposition is calculated. Absolute difference between baseline and post-treatment (e.g. \<60 minutes after the last dose of lucinactant or placebo) reported.
| Arm | Type | Description |
|---|---|---|
| Lucinactant first, then placebo | OTHER | Active treatment first, then washout period, then placebo treatment |
| Placebo treatment first, then lucinactant treatment | OTHER | 0.9% NaCl vehicle treatment first, then washout period, then lucinactant treatment |
| Name | Type | Description |
|---|---|---|
| Lucinactant first | DRUG | lucinactant 120 mg (20 mg/ml) x 5 doses over 24 hours, then washout period x 14 days, then vehicle x 5 doses over 24 hrs |
| Placebo first | DRUG | 6 mL normal saline x 5 doses over 24 hours, then washout period x 14 days, then lucinactant x 5 doses over 24 hours |
Inclusion Criteria: * Cystic fibrosis * FEV1\>40% Exclusion Criteria: * Unstable lung disease * Unable or unwilling to stop hypertonic saline and dornase alfa for 3 days prior to each study period * Relevant drug allergy or intolerance * Recent investigational drug use (30 days)
| 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 |