Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
L606 · 2 trials · 3 indications
(MSP for Cohort A): Proportion of patients with PAH or PH-ILD on a stable Tyvaso dose who would develop treatment-emergent AEs/SAEs after switching to L606 dosing for up to 2 weeks during MSP.
(OEP for Cohorts A and B): Proportion of subjects with PAH or PH-ILD, choosing to continue twice daily L606 dosing for up to 48 weeks, who would develop treatment emergent AEs/SAEs up to 48 hours after the last dose.
| Arm | Type | Description |
|---|---|---|
| L606 (in combination with nebulizer) | EXPERIMENTAL | - |
| Placebo (in combination with nebulizer) | PLACEBO_COMPARATOR | - |
| L606 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| L606 | DRUG | L606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer. |
| Placebo | DRUG | Placebo will match L606 but contain no treprostinil. |
| L606 inhalation suspension | COMBINATION_PRODUCT | L606 inhalation suspension |
Inclusion Criteria: * Participant is between 18 years to 80 years old. * Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging. * Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters: * Pulmonary...