Reata PH Study Expands to Include Patients with Interstitial Lung Disease

Reata Pharmaceuticals, Inc., recently announced the enrollment of the first patient with pulmonary hypertension associated with interstitial lung disease (PH-ILD) in its LARIAT study, a Phase 2 clinical trial assessing the safety, efficacy, and tolerability of bardoxolone methyl in patients with pulmonary hypertension (PH).

PH is characterized by unusually high pressure in the arteries and veins leading to and from the lungs, partly due to a narrowing of the pulmonary vasculature caused by inflammation, remodeling, proliferation, and endothelial dysfunction. Although PH does not involve metastasis or the disruption of tissue boundaries, it does share certain features with cancer, such as hyperproliferation and resistance to apoptosis, or programmed cell death, of vascular smooth muscle and other cells.

According to a Reata press release, the expanded LARIAT trial is now accepting PH patients with these types and classifications of interstitial lung disease (ILD):

• WHO Group 3 pulmonary arterial hypertension (PAH) patients with:
  • Connective tissue disease-associated (CTD-ILD)
  • Idiopathic pulmonary fibrosis (IPF)
  • Nonspecific interstitial pneumonia (NSIP)
• WHO Group 5 PH patients with sarcoidosis

Researchers responsible for the study recently presented data at the recent 2015 CHEST Annual Meeting, reporting that WHO Group 1 PH (pulmonary arterial hypertension) patients, under stable background therapies, showed improved functional capacity when administered bardoxolone methyl as assessed by the 6-minute walk testH.

Patients with connective tissue disease-associated PAH (CTD-PAH) tend to respond poorly to available therapies and have less successful outcomes. Yet these patients demonstrated the greatest magnitude changes after bardoxolone methyl treatment. Based on this clinical finding — plus preclinical data demonstrating activity of bardoxolone methyl and analogs in several types of CTD and fibrotic pulmonary conditions – Reata has expanded its PH program to also include ILD patients.

“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, and Reata’s chief medical officer. “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.”

More information, including information on how to participate in the trial, is available through this link.

Reata Pharmaceutics, based in Irving, Texas, is a clinical stage biopharmaceutical company focused on the development of product candidates that modulate key regulatory proteins involved in oxidative stress, mitochondrial function, and inflammation to address the unmet medical needs of people with serious or life-threatening illnesses.