Shots:

• The registrational part 2 of the P-II MOXIe study involves assessing of Omaveloxolone (150mg) vs PBO in 103 patients in a ratio (1:1) with FA at 11 sites across United States- Europe- and Australia for 48wks.
• The P-II MOXIe study results: met its 1EPs i.e- @48wks.- 2.40point improvement in mFARS; mean improvement in mFARS from baseline (-1.55 points vs +0.85 points); 1.93point improvement in mFARS in patients with pes cavus
• Omaveloxolone (PO- qd) is an investigational oral Nrf2 activator- promoting restoration of mitochondrial function- reduction of oxidative stress and inhibition of pro-inflammatory signaling and has received the US FDA & EMA’s ODD for FA

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