dm+d

Unassigned

New Medicines

Moderate-to-severe active ulcerative colitis (UC) in adults

Information

New molecular entity
Eli Lilly
Eli Lilly

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Pre-registration (Filed)
Mar 22Lilly submit a BLA to FDA and a MAA to EMA for mirikizumab in ulcerative colitis [9].
Dec 21Lilly announce plans to submit a Biologics License Application (BLA) in H1 2022 to the US FDA. They also plan to file for approval with other global regulatory agencies in the same timeframe. [7]

Category

A humanised IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23
UC has an incidence in the UK of approximately 10 per 100,000 people annually and a prevalence of approximately 240 per 100,000 [1].
Moderate-to-severe active ulcerative colitis (UC) in adults
Subcutaneous injection

Further information

Yes

Trial or other data

Mar 22In PIII LUCENT-2 study, a significantly higher proportion of patients receiving mirikizumab achieved clinical remission at 1 year vs. placebo (49.9% vs 25.1%; p<0.001) and reported fewer serious adverse events (3.3% vs 7.8%) [9].
Feb 22Company announce additional results from PIII LUCENT-1 study (n=1162). At 12 weeks, rate of clinical remission and response with mirikizumab vs. placebo was 24.2% vs 13.3% (p=0.00006) and 63.5% vs 42.2% (p<0.00001), respectively [8].
Dec 21Mirikizumab met the primary endpoint of clinical remission and all key secondary endpoints vs. placebo (p<0.001) at one year in PIII LUCENT-2 maintainence study in pts with moderate-to-severe active UC. More pts on mirikizumab achieved endoscopic and corticosteroid-free remission, absolute resolution, or near-resolution of bowel urgency. It also led to reduced intestinal inflammation, improved bowel urgency and maintenance of remission. Common adverse events were nasopharyngitis, arthralgia and exacerbation of UC. Hypersensitivity, injection site reactions, depression, liver enzyme elevation, herpes zoster and oral candidiasis were also reported. [7]
Mar 21Lilly announce PIII LUCENT 1 trial has met its primary endpoint. After 12 weeks, the rate of clinical remission was significantly higher in the mirikizumab arm than the placebo arm, p<0.0001. Mirikizumab also met all secondary endpoints with symptoms stopping as early as four weeks after treatment. Responders included those who had previously failed JAK inhibitors and biologic therapy. Full study results are expected early 2022 [6].
Jul 20PIII (LUCENT-ACT, NCT04469062) trial initiated to compare efficacy and safety of mirikizumab vs. vedolizumab in patients with moderate to severe UC. The estimated primary completion date is Mar 24 [5].
Jan 20PIII LUCENT 1 trial and its open-label extension LUCENT 3 are still recruiting, with estimated primary completion dates of Sep 2020 and Aug 2023, respectively. The PIII LUCENT 2 (NCT03524092) maintenance study is also recruiting, with estimated primary completion date of Jun 2021 [4]. NCT03524092
Dec 18PIII LUCENT 1 trial and its open-label extension due to complete in late 2020 and 2023, respectively [3]
Jul 18Open-label, extension PIII LUCENT 3 trial to evaluate the long-term efficacy and safety of the drug in patients with ulcerative colitis starts (NCT03519945). Recruitment of approximately 840 patients is ongoing in several countries including the US & EU (plus UK). Collection of primary outcome data (clinical remission) is due to complete Aug 23 [2].
Jun 18PIII LUCENT 1 trial to evaluate mirikizumab in patients with moderate-to-severe active ulcerative colitis starts (NCT03518086). The study intends to enrol 1160 patients from sites including in the US and EU (not UK). Collection of primary outcome data (clinical remission at week 12) is expected to complete Jun 20 [2].

Moderately to severely active Crohn's disease

Information

Licence extension / variation
Eli Lilly
Eli Lilly

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A humanised IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23
Prevalence in the UK is about 145 per 100.000 population [1].
Moderately to severely active Crohn's disease
Subcutaneous injection

Moderate-to-severe plaque psoriasis in adults

Information

New molecular entity
Eli Lilly
Eli Lilly

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Apr 21Eli Lilly have announced that the development program for mirikizumab will henceforth focus on the ulcerative colitis and Crohn´s disease indications. While the OASIS program generated positive results for mirikizumab with safety and efficacy similar to other IL-23p19s, the company no longer plans to submit mirikizumab for regulatory approval in psoriasis in any geography [11].

Category

A humanised IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23
Prevalence of psoriasis is estimated to be about 1.3-2.2% in the UK, with the highest prevalence being in white people. Men and women are equally affected. Plaque psoriasis accounts for 90% of all people with psoriasis [1].
Moderate-to-severe plaque psoriasis in adults
and intravenous
Subcutaneous injection