So ones to watchLilly has just presented phase 2 results with mirikizumab in moderate to severe Crohn’s – a form of inflammatory bowel disease – which reveal significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo.
That included an endoscopic response rate of 43.8% for patients on a 1,000mg dose of the IL-23 antibody, compared to 10.9% of the placebo group. Other doses of mirikizumab – 200mg and 600mg – achieved endoscopic response rates of 25.8% and 37.5% respectively.
Similar benefits on endoscopic remission rates and patient-reported remissions, plus a fairly clean safety profile, have prompted Lilly to accelerate plans for a phase 3 trial in Crohn’s later this year. The data was presented at this week’s Digestive Disease Week (DDW) medical conference in San Diego.
Crohn’s could be an important indication for Lilly, as mirikizumab is very much playing catch-up in the IL-23 inhibitor category when it comes to psoriasis.
First to market was Johnson & Johnson’s dual IL-12/IL-23 inhibitor Stelara (ustekinumab) for psoriasis, which rapidly achieved blockbuster status with add-on indications in psoriatic arthritis and Crohn’s and made $4bn in sales last year.
Stelara has since been joined by J&J’s follow-up IL-23 inhibitor Tremfya (guselkumab), Sun Pharma’s Ilumya(tildrakizumab) and AbbVie/Boehringer Ingelheim’s Skyrizi (risankizumab), which are all already FDA-approved for psoriasis and require fewer injections than Stelara with safety and efficacy that is at least as good. Tremfya also has data suggesting it works in Stelara-resistant psoriasis.
Lilly’s antibody is still in phase 3 for psoriasis, well behind the leaders, but IBD presents a greater opportunity for the drug. With Stelara already available for Crohn’s, Lilly is hoping to be among the leaders to market in this indication, although as Tremfya and Skyrizi are already in phase 3 it will have to move quickly.
Mirikizumab is however already in three phase 3 ulcerative colitis trials that will start generating results next year, and has a chance of being first to market in this indication – although once again it is in a race with Skyrizi, which also has phase 3 trials ongoing in this setting.
"Following last year's presentation of positive phase 2 results for mirikizumab for the treatment of moderate- to severe ulcerative colitis, we are excited to return to DDW to present more positive data for mirikizumab in patients with chronic, inflammatory gastrointestinal conditions,” said Lilly’s head of immunology R&D Lotus Mallbris.
“As we continue to advance the science of gastroenterology, we are hopeful that mirikizumab helps us raise the standard and make remission possible for people living with immune-mediated diseases like Crohn's disease.”
22nd May 2019