Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Airway Bypass · 1 trial · 1 indication
including but not limited to device-related blood vessel perforation, pneumothorax, COPD exacerbation, device migration, device removal, rehospitalization.
| Arm | Type | Description |
|---|---|---|
| Interventional | EXPERIMENTAL | Patients in the interventional arm will receive implant of one or more airway bypass devices. |
| Name | Type | Description |
|---|---|---|
| Airway Bypass | DEVICE | Bypass stent(s) are implanted to allow air trapped in the parenchyma to escape |
Inclusion Criteria: 1. Patient between 50 to 80 years old. 2. High Resolution CT scan indicates severe emphysema. 3. Patient has post- bronchodilator FEV1 less than or equal to 50% of predicted. 4. Total Lung Capacity \>100% of predicted. 5. Residual volume ≥225 % of predicted. 6. RV/TLC \>0.69 7. ...
Airway Bypass is an investigational therapy being developed for the treatment of emphysema or COPD. It is currently in early clinical development, with a Phase 1 safety and feasibility study underway. The therapy is not yet approved and remains in clinical trials.
Airway Bypass is being developed by Catalyst Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol CPRX. The company is conducting a Phase 1 clinical trial to evaluate the safety and feasibility of the therapy in patients with emphysema or COPD.
Airway Bypass is in Phase 1 clinical development. The ongoing study, NCT06249529, is an early Phase 1 trial designed to assess the safety and feasibility of the therapy. It is currently recruiting participants with emphysema or COPD.
Airway Bypass is being studied in one active clinical trial, NCT06249529, titled 'Airway Bypass - Safety and Feasibility Study.' This early Phase 1 trial is recruiting 10 participants with emphysema or COPD in Georgia. The study is uncontrolled and not randomized or double-blinded.
Airway Bypass is not FDA approved. It is an investigational therapy currently in Phase 1 clinical development. The ongoing trial is a safety and feasibility study, and the therapy has not yet completed clinical testing or received regulatory approval.