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Reata Announces New Preclinical Data Demonstrating the Potential of Omaveloxolone in the Treatment of Friedreich's Ataxia and Other Severe Neurological Diseases

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Wednesday, April 25, 2018

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IRVING, Texas - Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a clinical-stage biopharmaceutical company, announced new preclinical data demonstrating that omaveloxolone potently activates the Keap1/Nrf2 pathway, significantly reduces production of reactive oxygen species, and improves mitochondrial function in two different models of severe neurological diseases. These results support the rationale for clinical studies of omaveloxolone in neurodegenerative and neuromuscular disorders, including the ongoing pivotal MOXIe trial in patients with Friedreich's ataxia.

In one study, omaveloxolone treatment dose-dependently increased the expression of key Nrf2 target genes, decreased LPS-induced expression of pro-inflammatory genes, and improved mitochondrial function in several cell lines including hFXN154F mouse embryonic fibroblasts expressing a mutant human frataxin gene. These data were presented by Christian Wigley, Ph.D., Reata's Vice President of Research, at the ongoing 2018 American Academy of Neurology Annual Meeting in Los Angeles, CA.

In a separate study, independent academic researchers from University College London, University of Dundee, Tohoku University, Johns Hopkins University, and University of Muenster studied the effect of omaveloxolone treatment in a rodent model of epileptogenesis and chronic seizures resulting from kainic acid-induced status epilepticus. Acute treatment with omaveloxolone significantly and dose-dependently increased glutathione and ATP levels, prevented neuronal loss, and reduced the median frequency of late spontaneous seizures by 94%. Additionally, in vitro results from a mixed cortical neuronal cell culture demonstrated that omaveloxolone treatment improved mitochondrial metabolism, reduced production of reactive oxygen species, and prevented neuronal cell death. These results were recently published in an original research article titled, "KEAP1 inhibition is neuroprotective and suppresses the development of epilepsy" in Brain, a Journal of Neurology. The article can be found online at the following link:

"These studies add to the growing body of clinical and preclinical data demonstrating that omaveloxolone's mechanism of action has the potential to address a broad range of neurological and neuromuscular diseases," said Keith Ward, Ph.D., Reata's Chief Development Officer. "We are especially encouraged by the significant improvements in mitochondrial function and reduction in reactive oxygen species observed in these studies, as these are both known key drivers of pathogenesis in Friedreich's ataxia."

About Friedreich's Ataxia
Friedreich's ataxia is a rare, degenerative, life-shortening neuromuscular disorder that affects children and adults and involves the loss of strength and coordination usually leading to wheelchair use; diminished vision, hearing and speech; scoliosis (curvature of the spine); increased risk of diabetes; and a life-threatening heart condition. Currently, there are no FDA-approved treatments for Friedreich's ataxia.

About Omaveloxolone
Omaveloxolone 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 omaveloxolone for the treatment of Friedreich's ataxia.

About Reata Pharmaceuticals, Inc.
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.

Reata Pharmaceuticals, Inc.
(972) 865-2219

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Vinny Jindal
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(469) 374-8721

Matt Middleman, M.D.
LifeSci Public Relations
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Source: Reata Pharmaceuticals, Inc.
2.5 from 2 votes
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