LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

A Two-Part Phase 2 study to Assess LAM-001 (Inhaled Sirolimus) for the Treatment of Pulmonary Hypertension - Part A was a Single-Arm, Open-Label, Exploratory Study in Group 1 and Group 3 PH Patients (Completed) and Part B is a Phase 2, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LAM-001 in Adults with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD). In Part B, approximately 75 participants will receive standard of care plus LAM- 001 (inhaled sirolimus) 100 mcg, 200 mcg or placebo by oral inhalation once daily for the first 24 weeks of the study (Core Study). Participants who complete the first 24 weeks on treatment and appear to have a favorable benefit-risk profile will be eligible to continue receiving LAM- 001 at their current dose level for the remainder of the study (Open-Label Extension Period) for an additional 12 months. All participants will complete evaluations during a Follow-Up Period of 4 weeks. Part A was a single-arm, open-label, exploratory study assessing the efficacy and safety of LAM-001 as an add-on therapy for the treatment of 10 WHO Functional Class III participants with WSPH Group 1 or Group 3 pulmonary hypertension that has been completed. Part B is ongoing.