Reata to Present Initial Phase 2 Data on Bardoxolone Methyl, a Novel Experimental Therapy for Pulmonary Hypertension Used in Patients on Stable Background PAH Therapy
IRVING, Texas – September 16, 2015 – Reata Pharmaceuticals announced today that initial data evaluating bardoxolone methyl in pulmonary arterial hypertension (PAH) patients on stable background therapy will be presented at the 2015 American College of Chest Physicians (CHEST) annual meeting in Montreal, Canada.
The presentation is scheduled on October 27, 2015 as part of the Late-Breaking Abstracts session from 8:45 to 10:00 am, in the Palais des Congrès de Montréal Convention Center (Room 513ef). The presentation, “Initial Data Report from ‘LARIAT’: a Phase 2 Study of Bardoxolone Methyl in PAH Patients on Stable Background Therapy,” will be presented by Ronald Oudiz, M.D., Professor of Medicine, David Geffen School of Medicine at UCLA. Dr. Oudiz is Director of the Pulmonary Hypertension Center and a Faculty Cardiologist at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center in Southern California.
“We are excited to present top-line data from our Phase 2 LARIAT study. Bardoxolone methyl has the potential to be a first-in-class treatment for PAH that impacts aspects of the disease that are unaddressed by current therapies, including inflammation and mitochondrial dysfunction. Clinically, these manifest as markedly reduced exercise capacity and fatigue, despite optimal treatment with available therapies. In preclinical models, we have demonstrated that bardoxolone methyl directly improves mitochondrial function and energy production in the skeletal muscle while not affecting systemic hemodynamics,” said Colin Meyer, M.D., Reata’s Chief Medical Officer. “This profile is unique and should complement available therapies, all of which have primary vasodilatory effects. On the basis of the emerging preclinical and clinical data, we are further expanding our development program and plan to study bardoxolone methyl in other forms of pulmonary hypertension, including pulmonary hypertension caused by interstitial lung disease.”
About Bardoxolone Methyl
Bardoxolone methyl is an experimental, oral once daily antioxidant inflammation modulator (AIM) that has received orphan drug designation for the treatment of PAH by the US Food and Drug Administration. Bardoxolone methyl targets the Nrf2 pathway, which controls the transcription of genes that increase cellular antioxidant content and anti-inflammatory mediators. Preclinical data suggest that activation of the Nrf2 pathway also regulates multiple genes that promote the production of cellular energy within the mitochondria and facilitates mitochondrial homeostasis and efficiency. Unlike therapies that primarily promote vasodilation, preclinical data suggest that bardoxolone methyl may directly target inflammation as well as mitochondrial dysfunction in PAH. Bardoxolone methyl and analogs have demonstrated activity in preclinical models of lupus and scleroderma, and these autoimmune conditions contribute to the second most common subtype of PAH, known as connective tissue disease-associated PAH. The available preclinical data suggest that bardoxolone methyl has the potential to impact multiple aspects of PAH pathology not significantly attenuated by current therapies.
About the LARIAT Study
LARIAT (A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Pulmonary Hypertension) is a Phase 2 dose ranging study examining the safety, tolerability, and efficacy of bardoxolone methyl in patients with PAH on stable background therapy. To determine if bardoxolone methyl could complement approved PAH therapies, the Phase 2 study was designed to assess efficacy through exercise capacity.
This initial data report is from analysis performed on the initial 3 cohorts (24 patients). Patients were randomized 1:3 to receive once-daily placebo or bardoxolone methyl for 16 weeks. Patients were required to be stable on at least one approved PAH therapy. The primary efficacy variable, 6MWD, was collected at baseline and at every 4 weeks. For more details on the LARIAT study visit https://www.clinicaltrials.gov/ct2/show/NCT02036970.
About Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is a life-threatening disease involving chronic fatigue, endothelial dysfunction, vasoconstriction in small pulmonary arteries, dysregulated proliferation of certain vascular cells, and dysregulated pro-inflammatory signaling leading to vascular remodeling, pulmonary fibrosis, and right ventricular hypertrophy. PAH affects an estimated 15,000-20,000 people in the United States, predominantly middle-aged women. Available treatments for PAH can provide symptomatic improvement, primarily by relieving vasoconstriction. However, even with existing treatments the disease continues to progress, and PAH has a high mortality rate with 60 to 80 percent of patients dying within five years of diagnosis. Consequently, there is a very high unmet clinical need for new therapies.
About Reata Pharmaceuticals, Inc.
Reata Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company located in Irving, Texas, focused on the development of drugs that target proteins involved in the cellular biology of oxidative stress, inflammation, and mitochondrial function to address the unmet medical needs of patients with serious or life threatening diseases. We focus on drugs with novel mechanisms of action that modulate important regulatory proteins, called transcription factors, that coordinate the cellular response to stressors by activating or suppressing the activity of many target proteins. The effects of AIM pharmacology have been documented in more than 250 scientific papers and are potentially relevant to a wide range of diseases.
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