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 ...
| 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 |
P-1037 is an investigational small molecule being developed for the treatment of cystic fibrosis. It is designed to address the underlying respiratory complications of the disease. The drug is currently in clinical development and has not been approved by regulatory authorities.
P-1037 targets the epithelial sodium channel (ENaC) in the lungs. By inhibiting this channel, the drug aims to reduce sodium absorption and improve airway surface hydration in patients with cystic fibrosis. This mechanism is being studied as a potential therapeutic approach for the condition.
P-1037 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. Vertex is conducting clinical research to evaluate the safety and efficacy of P-1037 in patients with cystic fibrosis.
P-1037 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The Phase 2 trial has been completed, and the results will inform whether the drug advances to later-stage studies.
P-1037 has been studied in one completed Phase 2 clinical trial, identified as NCT02343445. This randomized, double-blind, placebo-controlled study enrolled 142 participants with cystic fibrosis in the United States. The trial evaluated the effects of ENaC inhibition on lung function and other outcomes.
P-1037 is a distinct investigational compound developed by Vertex Pharmaceuticals. It is not the same as other approved cystic fibrosis drugs, which target different molecular pathways. P-1037 specifically inhibits the epithelial sodium channel, a unique mechanism being explored for the disease.