Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GFF MDI · 1 trial · 1 indication
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24.
| Arm | Type | Description |
|---|---|---|
| FF MDI (PT005) | EXPERIMENTAL | FF MDI administered as two puffs BID |
| GP MDI (PT001) | EXPERIMENTAL | GP MDI administered as two puffs BID |
| GFF MDI (PT003) | EXPERIMENTAL | GFF MDI administered as two puffs BID |
| Placebo MDI | PLACEBO_COMPARATOR | Inhaled placebo administered as two puffs BID |
| Name | Type | Description |
|---|---|---|
| GFF MDI (PT003) | DRUG | GFF MDI administered as two puffs BID |
| GP MDI (PT001) | DRUG | GP MDI administered as two puffs BID |
| FF MDI (PT005) | DRUG | FF MDI administered as two puffs BID |
| Placebo | DRUG | - |
Key Inclusion Criteria: * Male or female subjects at least 40 years of age and no older than 80 at Visit 1. * Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) * Current or former smokers with a history of at l...
GFF MDI is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is administered via a metered dose inhaler and is currently in Phase 3 clinical development. The drug is intended for patients with moderate to very severe COPD.
GFF MDI is a small molecule therapy for COPD, but its specific molecular target has not been disclosed. The drug is being evaluated for its efficacy and safety in patients with moderate to very severe COPD, though the exact mechanism of action is not publicly detailed.
GFF MDI is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is advancing the drug through Phase 3 clinical trials for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
GFF MDI is currently in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, placebo-controlled study. The drug is not yet approved and remains investigational for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
GFF MDI has been studied in one completed Phase 3 clinical trial, identified as NCT01854658. This trial, titled PINNACLE 2, assessed the efficacy and safety of the drug in 1,615 patients with moderate to very severe COPD. The study was conducted in the United States and enrolled adults aged 40 years and older.
GFF MDI is associated with the drug combination PT003, which was evaluated in the PINNACLE 2 clinical trial (NCT01854658). The trial assessed PT003, PT005, and PT001 in patients with COPD, and GFF MDI refers to this formulation being developed by cbdMD, Inc.