Phase III LUCENT-1 study of LY 3074828 achieved statistical significant improvements in ulcerative colitis.- Eli Lilly

Patients who took mirikizumab also achieved statistically significant improvements across key secondary endpoints including clinical, symptomatic, endoscopic and histologic (cellular level of tissue) measures, compared to those taking placebo. This global study of 1,162 patients included patients who had never tried a biologic treatment (biologic-naïve) and harder-to-treat patients who had previously taken a biologic that failed. One in four patients treated with mirikizumab (24.2%, n=210/868) achieved the primary endpoint of clinical remission at 12 weeks, compared to one in seven on placebo (13.3%, n= 39/294, p=0.00006), indicating improved symptom relief and resolution or near resolution of inflammation. Nearly two-thirds of patients taking mirikizumab (63.5%, n=551/868) achieved clinical response, compared to less than half of patients treated with placebo (42.2%, n=124/294, p<0.00001).></0.00001).>

Nearly half of patients taking mirikizumab (45.5%, n=395/868) achieved symptomatic remission at 12 weeks, compared to less than a third of patients taking placebo (27.9%, n=82/294, p<0.001). in as early as four weeks, more than one in five patients who took mirikizumab (21.8%, n="189/868)" experienced a rapid improvement in their symptoms, compared to approximately one in eight patients taking placebo (12.9%, n="38/294," p><0.001).></0.001).></0.001).>

In as early as two weeks and sustained through 12 weeks, patients treated with mirikizumab had a statistically significant reduction on an 11-point bowel urgency severity scale. At 12 weeks, patients had an average reduction of 2.59 (2.32 to 2.85) points, compared to an average reduction of 1.63 (1.18 to 2.09) points for patients on placebo (p<0.00001). the 2-week bowel urgency endpoint was pre-defined but was not multiplicity-controlled. the overall safety profile was similar to that of previous mirikizumab studies in uc and consistent with that of other anti-il-23p19 antibodies in other therapeutic areas. patients taking mirikizumab, compared to those on placebo, reported a lower frequency of serious adverse events (mirikizumab: 2.8%, n="27;" placebo: 5.3%, n="17)" and were less likely to discontinue the study due to adverse events (mirikizumab: 1.6%, n="15;" placebo: 7.2%, n="23)." results from lilly's first-in-class induction study are being presented virtually at the 17th congress of the european crohn's and colitis organisation (ecco).></0.00001).>