TABLE 3.
Investigational therapies for COPD-pulmonary hypertension (PH) and interstitial lung disease (ILD)-PH
| Compound, clinicaltrials.gov identifier [reference] | Pathway/mechanism | Trial | End-points | Company/institution |
|---|---|---|---|---|
| COPD-PH | ||||
| MK-5475-03, NCT05612035 [177] | Daily inhaled sGC | Phase 2a INSIGNIA-PH-COPD |
Efficacy (6MWD) and safety | Merck |
| Tadalafil, NCT05844462 [178] | Daily PDE-5i | Phase 3 ERASE PH-COPD |
Efficacy (6MWD) and safety in severe PH | Assistance Publique Hôpitaux de Paris |
| ILD-PH | ||||
| Treprostinil palmitil, NCT05176951 [179] | Daily DPI formulation of inhaled treprostinil (prostanoid) prodrug | Phase 2 extension |
Safety and tolerability | Insmed |
| Treprostinil, NCT06129240 [180] | Four times daily DPI formulation of inhaled prostanoid | Phase 3 ASCENT extension |
Safety and tolerability | Liquidia |
| Inhaled treprostinil, NCT04691154 [181] | Twice daily aerosolised liposomal prostanoid | Phase 2 open label | Safety and tolerability | Liquidia/Pharmosa |
| Hymecromone, NCT05128929 [182] | Twice daily oral coumarin derivative (inhibitor of hyaluronan synthesis) | Phase 2 SATURN study |
Safety and tolerability | Stanford University |
| Bardoxolone methyl, NCT03068130 [183] | Antioxidant (acts via Nrf2 pathway) | Phase 2 LARIAT and RANGER studies |
6 IPF-PH, 4 IIP-PH 17 CTD ILD-PH patients 6MWD change of +38 m in the IPF-PH cohort |
Reata/Biogen |
sGC: soluble guanylate cyclase; 6MWD: 6-min walk distance; PDE-5i: phosphodiesterase-5 inhibitor; DPI: dry powder inhaler; IPF: idiopathic pulmonary fibrosis; IIP: idiopathic interstitial pneumonia; CTD: connective tissue disease.