IRVING, TX, USA I October 23, 2017 I Reata Pharmaceuticals, Inc. (NASDAQ:RETA) (“Reata” or the “Company”) today announced the enrollment of the first patient in the pivotal Part 2 of the MOXIe trial to evaluate omaveloxolone in patients with Friedreich’s ataxia (FA).
“Friedreich’s ataxia is a severe, neurological disorder that profoundly impacts patients and their families. Based on the results from Part 1 of MOXIe, we are optimistic that Part 2 of the MOXIe trial could position omaveloxolone to become the first therapy approved for patients with Friedreich’s ataxia,” said Warren Huff, Reata’s Chief Executive Officer and President. “With the initiation of Part 2 of MOXIe, Reata has launched three pivotal programs in the last 12 months.”
Part 2 of the MOXIe trial is a double-blind, randomized, placebo-controlled, multi-center, international trial designed to evaluate the safety, tolerability, and efficacy of omaveloxolone in patients with FA. The trial will enroll approximately 100 FA patients randomized evenly to either 150 mg of omaveloxolone or placebo. The primary endpoint of the trial will be the change from baseline in the modified Friedreich’s Ataxia Rating Scale (mFARS) of omaveloxolone compared to placebo at 48 weeks. Additional endpoints will include the change from baseline in peak work during maximal exercise testing, Patient Global Impression of Change, and Clinical Global Impression of Change. The U.S. Food and Drug Administration has confirmed that use of mFARS as the primary endpoint in Part 2 of the MOXIe trial can support approval of omaveloxolone in FA. Reata expects top-line data to be available in the second half of 2019.
About Friedreich’s Ataxia
FA is a rare, degenerative, life-shortening neuro-muscular 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 FA.
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.
SOURCE: Reata Pharmaceuticals
Post Views: 31
IRVING, TX, USA I October 23, 2017 I Reata Pharmaceuticals, Inc. (NASDAQ:RETA) (“Reata” or the “Company”) today announced the enrollment of the first patient in the pivotal Part 2 of the MOXIe trial to evaluate omaveloxolone in patients with Friedreich’s ataxia (FA).
“Friedreich’s ataxia is a severe, neurological disorder that profoundly impacts patients and their families. Based on the results from Part 1 of MOXIe, we are optimistic that Part 2 of the MOXIe trial could position omaveloxolone to become the first therapy approved for patients with Friedreich’s ataxia,” said Warren Huff, Reata’s Chief Executive Officer and President. “With the initiation of Part 2 of MOXIe, Reata has launched three pivotal programs in the last 12 months.”
Part 2 of the MOXIe trial is a double-blind, randomized, placebo-controlled, multi-center, international trial designed to evaluate the safety, tolerability, and efficacy of omaveloxolone in patients with FA. The trial will enroll approximately 100 FA patients randomized evenly to either 150 mg of omaveloxolone or placebo. The primary endpoint of the trial will be the change from baseline in the modified Friedreich’s Ataxia Rating Scale (mFARS) of omaveloxolone compared to placebo at 48 weeks. Additional endpoints will include the change from baseline in peak work during maximal exercise testing, Patient Global Impression of Change, and Clinical Global Impression of Change. The U.S. Food and Drug Administration has confirmed that use of mFARS as the primary endpoint in Part 2 of the MOXIe trial can support approval of omaveloxolone in FA. Reata expects top-line data to be available in the second half of 2019.
About Friedreich’s Ataxia
FA is a rare, degenerative, life-shortening neuro-muscular 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 FA.
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.
SOURCE: Reata Pharmaceuticals
Post Views: 31
