Eli Lilly's mirikizumab helped patients with Crohn's disease achieve long-term remission in a phase 3 trial, teeing up the interleukin-23p19 antagonist for global regulatory submissions.
In the VIVID-1 study, mirikizumab met the co-primary and all major secondary endpoints compared to placebo, the drugmaker shared in a press release. 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.
While mirikizumab did not achieve superiority to J&J's Stelara in endoscopic response (a measure of disease severity), Lilly said results with mirikizumab were still numerically higher.
Data in hand, Lilly plans to submit a marketing application for mirikizumab in Crohn's disease to the FDA, followed by submissions to regulatory agencies around the world, in 2024.
The results are good news for the drugmaker, following the FDA's rejection of mirikizumab in ulcerative colitis. Back in April, the agency hit Lilly with complete response letter, citing concerns about the proposed manufacturing process for the drug.
Mirikizumab was originally developed for psoriasis but achieved statistically superior rates of clinical remission at 12 weeks compared to patients taking a placebo in phase 3 trials in ulcerative colitis. The drug is racing to become the first and only anti-IL23p19 treatment for people with ulcerative colitis in the U.S.
If Lilly can get regulators on board, the drug has blockbuster potential, with sales projected to reach $14.6 billion by the end of 2038.