Scleroderma News correspondent Dr. Ana de Barros conducted an exclusive interview with Dr. Colin Meyer, chief medical officer and vice president of product development at Reata Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company based in Irving, Texas. The interview took place during the 4th Systemic Sclerosis World Congress held in Lisbon, Portugal, on Feb. 18–20, 2016.
Bardoxolone methyl, an antioxidant inflammation modulator (AIM), is one of Reata’s lead products and has the potential to address several aspects of pulmonary arterial hypertension (PAH) pathology. AIMs can activate the master transcription factor Nrf2, which acts as the primary cellular defense against cytotoxic effects, influencing the expression of hundreds of genes. AIMs have been reported to stimulate the production of proteins with antioxidant, anti-inflammatory, and cytoprotective properties.
Bardoxolone methyl is currently being evaluated as an add-on therapy for PAH in a Phase 2 clinical trial — the LARIAT study — a 16 week, randomized, placebo controlled, double-blind, multicenter trial. The drug has been shown to have antioxidative, anti-fibrotic, and anti-inflammatory properties, as well as beneficial effects on endothelial dysfunction.
In the particular case of patients whose PAH is associated with connective tissue diseases, such as systemic sclerosis, bardoxolone methyl was found to offer significant clinical benefits. This finding is important because these patients are known to often respond poorly to available therapies. As Dr. Meyer noted in the interview, “when we conducted our Phase 2 LARIAT study, some of the patients within that study had connective tissue diseases associated with pulmonary arterial hypertension, and those patients showed the largest signal of efficacy.”
Dr. Meyer in the interview also goes into more detail in the pathways targeted by bardoxolone methyl in comparison to approved PAH drugs, and why it may play a significant role as an add-on therapy, ultimately improving treatment efficacy.
Reata recently announced plans for a Phase 3 clinical trial to further assess the therapeutic effects of bardoxolone methyl in patients with connective tissue disease associated-PAH. According to Dr. Meyer, that trial will be initiated in late 2016 and is expected to involve about 100 clinical sites in some 15 different countries. Patients with all types of connective tissue diseases will be considered eligible for this trial, Dr. Meyer said, adding, “we expect most patients will have scleroderma, but patients with lupus or mixed connective tissue disease will also be allowed to enroll in the study.”
The complete Scleroderma News interview with Dr. Meyer is available below, or can be accessed through this link.