Until 18th October, bardoxolone methyl (Abbott/Reata) and BG-12 (Biogen) had two things in common: the nrf2 transcription factor complex as their molecular target; and their candidacy for blockbuster status. Then Reata halted clinical development of bardoxolone, following an excess of unspecified serious adverse events and mortality among the treated patients in the Phase 3 BEACON trial in chronic kidney disease. Almost simultaneously, the FDA paused for breath in their assessment of BG-12, delaying a decision on approval – although Biogen argue that the delay is unrelated to the sudden collapse of the bardoxolone programme. Should Biogen shareholders be concerned? Is this the end of the road for nrf2 activators?.........
"We need to watch this space. I agree with Biogen-Idec's position. BG12 is an improved version of Fumaderm that has been used in psoriasis for many years without any major safety signal. I am still confident that it will get both European and US license."