Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lucinactant first · 1 trial · 1 indication
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 | 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 |
Lucinactant first is an investigational small molecule being studied for the treatment of cystic fibrosis, a respiratory condition. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being developed by Windtree Therapeutics, Inc. (NASDAQ: WINT).
Lucinactant first is a small molecule being studied for cystic fibrosis. Its specific molecular target has not been disclosed in available information. The drug is being evaluated for its effect on mucus clearance in cystic fibrosis lung disease, as indicated by the completed Phase 2 clinical trial.
Lucinactant first is being developed by Windtree Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol WINT. The company is conducting clinical research on this drug for the treatment of cystic fibrosis, a respiratory disease.
Lucinactant first is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. A Phase 2 clinical trial for this drug has been completed, and the drug remains under investigation for cystic fibrosis.
Lucinactant first has one completed Phase 2 clinical trial registered as NCT00934362, titled "Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease." The trial enrolled 16 participants in the United States, was randomized, double-blind, and controlled, and included patients aged 14 years and older.