Reata Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company based in Irving, Texas, recently announced that it has enrolled the first patient with pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the Phase 2 LARIAT clinical trial, assessing the efficacy, safety and tolerability of bardoxolone methyl in patients with pulmonary hypertension (PH).
The LARIAT study is now being expanded to include PH-ILD patients in these two categories:
- WHO Group 3 connective tissue disease-associated ILD (CTD-ILD), idiopathic pulmonary fibrosis (IPF), and nonspecific interstitial pneumonia (NSIP);
- WHO Group 5 pulmonary hypertension patients with sarcoidosis.
Data of efficacy analyses recently presented at the CHEST meeting showed that 16 weeks of treatment with bardoxolone methyl (doses of 2.5 mg to 10 mg) increased 6-minute walk distance (6MWD), a measure of exercise capacity, in WHO Group 1 PH (pulmonary arterial hypertension) patients. All patients were on stable doses of background PH therapies at baseline and throughout the study.
Reata is expanding its PH program to interstitial lung disease patients based on preclinical and clinical data showing activity of bardoxolone methyl and analogs in several types of connective tissue disease and fibrotic pulmonary conditions. A greater therapeutic effect was, in fact, observed in patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH); these patients usually respond poorly to available therapies and have worse overall clinical outcomes.
“We are pleased to announce that we have quickly expanded our PH program into interstitial lung disease patients who have no approved therapies to treat their pulmonary hypertension,” said Colin Meyer, MD, Reata’s chief medical officer, in a press release it provided to Lung Disease News. “We hypothesize that bardoxolone methyl’s novel mechanism of action of improving mitochondrial function and suppressing inflammation can translate to improved functional capacity in PH patients with interstitial lung disease.”
The goal of the LARIAT study is to assess the safety, efficacy, and tolerability of bardoxolone methyl relative to a placebo in patients with PH, to determine the recommended dose range, and to evaluate the effect of bardoxolone methyl in pulmonary hypertension associated with connective tissue disease, interstitial lung disease, and idiopathic etiologies. The latter includes subsets of patients with WHO Group 3 and WHO Group 5 PH.
PH is a multi-organ condition characterized by abnormally high pressure in the network of arteries and veins that lead to and from the lungs due, in part, to narrowing of the pulmonary vasculature as a result of inflammation, remodeling, proliferation, and endothelial dysfunction. ILD patients experience extensive pulmonary vascular remodeling, and 30% to 40% of them ultimately develop PH-ILD. This disease falls under both WHO Groups 3 and 5, and PH-ILD patients have a one-year survival rate of approximately 63%, as compared to 92% for ILD patients without PH.
More information on this trial, including enrollment information, is available through this link.