Approval Probability
TA Base Rate
Adjusted LOA
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PUR0200 · 1 trial · 1 indication
adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated
| Arm | Type | Description |
|---|---|---|
| PUR0200 low dose | EXPERIMENTAL | PUR0200 low dose, single dose inhalation |
| PUR0200 mid dose | EXPERIMENTAL | PUR0200 mid dose, single dose inhalation |
| PUR0200 high dose | EXPERIMENTAL | PUR0200 high dose, single dose inhalation |
| Placebo | PLACEBO_COMPARATOR | PUR0200 matched placebo, single dose, inhalation |
| Active Comparator | ACTIVE_COMPARATOR | Active Comparator, single dose, inhalation |
| Name | Type | Description |
|---|---|---|
| PUR0200 | DRUG | Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator |
| PUR0200 Placebo | DRUG | Randomized, single dose of inhaled placebo matched to PUR0200 |
| Active comparator | DRUG | Randomized single dose of inhaled active comparator product |
Key Inclusion Criteria: * A clinical diagnosis of moderate to severe COPD according to the following criteria: * Current or ex-smokers with at least 10 pack-year smoking history * Post-bronchodilator FEV1 \>/= 35% and \</= 80% of predicted normal value * Post-bronchodilator FEV1/FVC (forced ...
PUR0200 is an investigational small molecule developed by Pulmatrix, Inc. for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It has been studied in a Phase 1 clinical trial to evaluate its safety, pharmacokinetics, and pharmacodynamics in patients with COPD. PUR0200 is not yet approved for any indication.
PUR0200 is being developed by Pulmatrix, Inc., a biopharmaceutical company that trades under the ticker symbol PULM. Pulmatrix is focused on developing inhaled therapies for respiratory diseases, and PUR0200 is one of its product candidates for COPD.
PUR0200 is in Phase 1 clinical development. It has completed one Phase 1 trial in patients with COPD. As a Phase 1 investigational drug, PUR0200 has not been approved by the FDA or any other regulatory agency for commercial use.
PUR0200 has been evaluated in a completed Phase 1 clinical trial, NCT01921712, titled 'A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients.' The trial enrolled 38 participants with COPD in the United Kingdom. It was randomized, double-blind, and placebo-controlled.
No, PUR0200 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial for COPD. Further clinical development would be required before any potential regulatory approval.