Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PUR1800 · 1 trial · 1 indication
Review of adverse events
Review of spirometry data
Breaths per minute
Systolic pressure over diastolic pressure
Beats per minute
As a percentage
Medical record review
Physician's notes
Lab reports with any out of range results flagged
ECG report and tracing
Review of spirometry data
Review of concomitant medications administered
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | The placebo designed for administration in the proposed clinical study consists of a dry powder composed of the same excipients as the active (sodium sulfate, mannitol and polysorbate 80), pre-metered into HPMC capsules at the same 5 mg powder fill weight as the active formulations. Subjects will receive 14 doses administered once daily in the morning. |
| PUR1800 250 μg | ACTIVE_COMPARATOR | The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to 250 μg and 500 μg nominal dose strengths of RV1162. Subjects will receive 14 doses administered once daily in the morning. |
| PUR1800 500 μg | ACTIVE_COMPARATOR | The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to 250 μg and 500 μg nominal dose strengths of RV1162. Subjects will receive 14 doses administered once daily in the morning. |
| Name | Type | Description |
|---|---|---|
| Placebo Comparator | DRUG | The placebo designed for administration in the proposed clinical study consists of a dry powder composed of the same excipients as the active (sodium sulfate, mannitol and polysorbate 80), pre-metered into HPMC capsules at the same 5 mg powder fill weight as the active formulations. Subjects will receive 14 doses administered once daily in the morning. |
| PUR1800 250 ug | DRUG | The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 250 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning. |
| PUR1800 500 ug | DRUG | The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 500 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning. |
Inclusion Criteria: Patients must meet all the following: 1. Male or female patients aged 40 to 75 years of age with a body mass index ≥ 17 and ≤ 35 kg/m2. 2. Female patients must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control metho...
PUR1800 is an investigational inhaled small molecule being developed for chronic obstructive pulmonary disease (COPD). It is not approved for any indication and remains in clinical development. Pulmatrix, Inc. (PULM) studied it in a Phase 1b trial in patients with COPD to evaluate its safety and tolerability.
PUR1800 is being developed by Pulmatrix, Inc., a biopharmaceutical company that trades under the ticker PULM. The company sponsored the Phase 1b study of PUR1800 in patients with COPD, which was conducted in the United Kingdom.
PUR1800 is in Phase 1 development. The only reported trial is a completed Phase 1b study in patients with COPD. No later-phase trials have been registered, and the drug is not approved for marketing in any country.
PUR1800 has been evaluated in one clinical trial: NCT04759807, a Phase 1b study titled "A Phase 1b Study of PUR1800 in Patients With COPD." The trial enrolled 18 participants, was randomized, double-blind, and placebo-controlled, and has been completed. It was conducted in the United Kingdom.