Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
P-1037 · 1 trial · 1 indication
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 ...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-581, VX-272 |
| 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 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
P-1037 is an investigational small molecule developed by Vertex Pharmaceuticals for cystic fibrosis, a respiratory disease. It was studied in a Phase 2 trial that enrolled 142 participants aged 12 years and older in the United States. The trial evaluated P-1037 in patients with cystic fibrosis.
P-1037 is being developed by Vertex Pharmaceuticals Incorporated, which trades on the Nasdaq under the ticker VRTX. Vertex is the sponsor of the clinical program for P-1037 in cystic fibrosis.
P-1037 is in Phase 2 clinical development for cystic fibrosis. One Phase 2 trial has been completed, and no active trials are currently listed. The completed trial was randomized, double-blind, and placebo-controlled, enrolling 142 participants.
P-1037 has been studied in one completed Phase 2 trial, NCT02343445, titled "Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF)." The trial enrolled 142 participants with cystic fibrosis in the United States and was randomized, double-blind, and placebo-controlled.
P-1037 is not approved; it is an investigational drug still in clinical development. It has completed a Phase 2 trial for cystic fibrosis, and further studies would be needed to support a potential regulatory submission.