Significant Improvement in 6MWD in Patients With IPF and Sarcoidosis
No Safety Signals Identified
The purpose of the trial was to assess effects on 6MWD in patients with PH and idiopathic pulmonary fibrosis (IPF) or sarcoidosis, which are both common forms of ILD. The placebo-controlled trial was 16 weeks in duration, randomized eight patients with IPF and 25 patients with sarcoidosis 2:1 to bardoxolone or placebo, and had sufficient power to detect improvements in 6MWD compared to baseline. There are no available therapies approved specifically to treat patients with PH and ILD because available vasodilators that are approved for pulmonary arterial hypertension have been unable to demonstrate efficacy and safety in these patients.
After 16 weeks of treatment, IPF patients randomized to bardoxolone demonstrated a significant increase in 6MWD from baseline of 38 m (p<0.05) whereas placebo-treated patients had a non-significant reduction of 13 m. Sarcoidosis patients randomized to bardoxolone also demonstrated a significant increase in 6MWD at week 16 from baseline of 17 m (p<0.05) whereas placebo-treated patients had a non-significant increase of 9 m.
“An estimated one half of IPF patients develop pulmonary hypertension, and these patients have rapidly progressive disease and poor outcomes. The magnitude in six-minute walk distance increases observed in IPF patients is as large as the increases we observed in CTD-PAH patients in our Phase 2 LARIAT study,” said
About Bardoxolone Methyl
Bardoxolone methyl is an experimental, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. The FDA has granted orphan designation to bardoxolone methyl for the treatment of Alport syndrome and pulmonary arterial hypertension. Bardoxolone methyl is currently being studied in CARDINAL, a Phase 3 study for the treatment of Alport syndrome, and CATALYST, a Phase 3 study for the treatment of CTD-PAH.
Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata’s two most advanced clinical candidates, bardoxolone methyl and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.
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Vice President, Strategy
Matt Middleman, M.D.
LifeSci Public Relations
Source: Reata Pharmaceuticals, Inc.