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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02343445 | Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF) | PHASE2 | COMPLETED | 142 | — | — | Apr 1, 2015 | Feb 1, 2016 | Jul 26, 2021 | 33 | United States |
number of adverse events of P-1037 in treatment groups
change in FEV1 from predosing to 1 hour post dosing with P-1037 in 4.2 % hypertonic saline and P-1037 in 0.17% saline
| Arm | Type | Description |
|---|---|---|
| P-1037 in Hypertonic Saline (HS) | EXPERIMENTAL | P-1037 Solution for Inhalation, 85 μg twice daily (BID) (28.3 μg/mL) in hypertonic saline (4.2% saline) BID |
| P-1037 in Saline | EXPERIMENTAL | P-1037 Solution for Inhalation, 85 μg BID (28.3 μg/mL) in 0.17% saline BID |
| Saline | PLACEBO_COMPARATOR | Placebo (0.17% saline) BID |
| Hypertonic Saline | SHAM_COMPARATOR | Hypertonic saline (4.2% saline) BID |
| Name | Type | Description |
|---|---|---|
| P-1037 | DRUG | P-1037 is a novel ENaC inhibitor |
| Hypertonic Saline | DRUG | 4.2% saline solution |
| Saline | DRUG | 0.17% saline solution |
Inclusion Criteria: * Male or female, 12 years of age or older. * Diagnosis of cystic fibrosis as determined by the 1997 CF Consensus criteria (NIH Consensus Statement, 1997) * Non-smoker * FEV1 at Screening Visit 1 between 40% and 90% * Stable regimen of CF medications and chest physiotherapy for ...
| 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 |