Shots:

• The first patient has been dosed in the P-III TOPAZ-1 study evaluating efficacy & safety of BIIB059 vs PBO in 540 adults with active SLE for 52 wks. The trial is expected to conduct at ~135 sites globally
• The 1EPs of study are to demonstrate a reduction in disease activity- proportion of patients achieve an SRI-4 response @ 52 wks. & 2EPs will evaluate the effect of BIIB059 on additional efficacy parameters include patients achieve SRI-4 response @ 24 wks. & evaluates the safety
• The results from the P-II LILAC study support the initiation of the P-III TOPAZ-1 study. The LILAC study met its 1EPs & demonstrates a significant reduction of disease activity & the majority of AEs were mild or mod.

| Ref: Biogen | Image: Biogen