Eli Lilly and Company
LLY
announced new efficacy and safety data from the phase II SERENITY study, which is evaluating its pipeline candidate mirikizumab. This mid-stage study evaluated intravenous (“IV”) or subcutaneous (“SC”) administration of the candidate for the safety and efficacy of multiple dosing regimens to treat moderately-to-severely active Crohn’s disease, a form of inflammatory bowel disease (“IBD”).
The 52-week study consisted of a 12-week induction period and the continued treatment period of 40 weeks. The company continued treatment with mirikizumab in patients who showed endoscopic improvement at week 12 for the next 40 weeks.
Data from the continued portion of the study showed continued symptom improvement and reduction of intestinal mucosal inflammation in patients following treatment with mirikizumab for a year. While nearly 60% patients achieved endoscopic response (defined as reduction of at least 50% from the baseline in Simple Endoscopic Score for Crohn’s Disease [SES-CD]), more than 45% of patients achieved PRO remission (defined as average daily stool frequency of less than or equal to 2.5 and abdominal pain less than or equal to 1 and not worse than the baseline).
Notably, the company completed the induction period and reported that the SERENITY study met its primary and secondary endpoints last year. An ongoing pivotal phase III study VIVID is evaluating mirikizumab as a potential treatment of patients with Crohn’s disease. Encouraging data from the 40-week continued treatment period reinforces the continued evaluation of mirikizumab in the late-stage study.
Data from continued portion also showed that 69.6% and 66.7% of patients in the IV and SC groups, respectively, of the subset of patients who achieved endoscopic response at week 12 also had endoscopic response at week 52. Moreover, 50.0% and 64.3% of patients in the respective IV and SC groups, who had endoscopic remission at week 12, also achieved endoscopic remission (defined as achieving an SES-CD score less than 4 for ileal-colonic disease or less than 2 for isolated ileal disease and no subscore greater than 1) at week 52.
Lilly’s shares have risen 17.6% this year so far compared with the
industry
’s increase of 0.5%.
Immunology is a key therapeutic area of Lilly and its portfolio includes popular drug Taltz, which is marketed for the treatment of psoriasis and psoriatic arthritis. Successful development of mirikizumab as a potential treatment of Crohn’s Disease will boost the company’s portfolio. However, there are several drugs approved for treating Crohn’s disease, which include AbbVie’s
ABBV
blockbuster drug Humira. Meanwhile, AbbVie’s psoriasis drug Skyrizi (risankizumab), Galapagos
GLPG
and Gilead’s
GILD
filgotinib, and RedHill Biopharma Ltd’s RHB-104 are in late-stage studies for Crohn’s disease.
Zacks Rank
Lilly currently has a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
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