Eli Lilly Treatment For Crohn's Tops Placebo In Latest Study, Makes Plans For 2024

Eli Lilly And Co LLY plans to submit a marketing application for a drug that treats Crohn's disease to the Food and Drug Administration (FDA) in 2024.

The company recently announced that mirikizumab met the co-primary and all major secondary endpoints compared to the placebo in VIVID-1 Phase 3 study of mirikizumab for moderately to severely active Crohn's disease. 

The trial included mirikizumab, placebo, and active control Johnson & Johnson's JNJ Stelara (ustekinumab) arms.

In the VIVID-1 study, all patients in the active treatment arms from the 12-week induction period continued with their original therapy into the maintenance portion of the study up to Week 52.

Also Read: FDA Declines To Approve Eli Lilly's Eczema Drug

Placebo patients who did not achieve clinical response at Week 12 (nonresponders) were switched to blinded mirikizumab treatment.

In the mirikizumab arm, a statistically higher proportion achieved clinical response at Week 12 and clinical remission at Week 52 compared to placebo (45.4% versus 19.6%).

In the mirikizumab arm, a statistically higher proportion achieved clinical response at Week 12 and endoscopic response at Week 52 compared to placebo (38% versus 9%).

Notably, of the patients who received mirikizumab, 54.1% achieved clinical remission at Week 52 compared to 19.6% of patients who received a placebo. 

In addition, for the endpoint of clinical remission, mirikizumab demonstrated non-inferiority versus ustekinumab (non-inferiority margin of 10%). 

For the endpoint of endoscopic response at Week 52, mirikizumab did not achieve superiority to ustekinumab, although results with mirikizumab were numerically higher, particularly in the non-multiplicity-controlled bio-failed population.

Price Action: LLY shares are up 0.31% at $607.13 during the premarket session on the last check Thursday.