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Eli Lilly's Ixekizumab Met Primary Endpoint In Patients With Plaque Psoriasis

Eli Lilly and Co. (LLY) said that new Phase II data, published in the New England Journal of Medicine, showed that the Company's ixekizumab, an anti-IL-17 monoclonal antibody, met its primary endpoint in patients with moderate-to-severe plaque psoriasis, with significantly more patients achieving at least a 75 percent improvement in Psoriasis Area and Severity Index or PASI scores from baseline or PASI 75 compared with placebo at week 12.

In the 142-subject study, significantly more patients achieved a PASI 75 response in the 150 mg (82 percent), 75 mg (83 percent) and 25 mg (77 percent) ixekizumab groups compared with placebo (8 percent, p<0.001) at week 12. The 10 mg dose (29 percent) did not separate from placebo at week 12, the company said.

Secondary endpoints included an evaluation of the percentage of patients achieving at least 90 percent and 100 percent improvement in PASI (PASI 90 or PASI 100) at week 12.

In patients treated with ixekizumab, the percentages of patients achieving a PASI 90 response were 71 percent (150 mg), 59 percent (75 mg) and 50 percent (25 mg), which were significantly higher than with placebo (0 percent).

PASI 100 responses were significantly better at the 150 mg dose (39 percent) and 75 mg dose (38 percent) when compared with placebo (0 percent). PASI 100 responses at the 25 mg (17 percent) and 10 mg doses (0 percent) were not significantly greater than placebo, nor was the PASI 90 response at the 10 mg dose (18 percent).

by RTTNews Staff Writer

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