GSK, MorphoSys RA therapy misses in Phase IIb

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said GSK3196165 (formerly MOR103) plus methotrexate missed the primary endpoint in the Phase IIb BAROQUE trial to treat moderate to severe rheumatoid arthritis in patients who had an inadequate response to methotrexate. GSK said the results support further clinical development of the product to treat RA, but did not disclose details.

The trial's primary endpoint measured the proportion of patients with clinical remission at week 24, defined as achieving a disease activity score using 28 joint counts calculated using C-reactive protein (DAS28-CRP) of less than 2.6 points. The highest dose of GSK3196165 led to a clinical remission rate at week 24 of 16% vs. 3% for placebo (p=0.134). That dose did significantly improve DAS28-CRP score from baseline to weeks 12 (placebo-adjusted difference of 1.27 points, p<0.001) and 24 (placebo-adjusted difference of 1.82 points, p<0.001) vs. placebo. GSK3196165 was well tolerated with no treatment-limiting safety findings reported...