INDIANAPOLIS, June 5, 2018 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today new safety and efficacy data
from a Phase 2 study evaluating mirikizumab in patients with
moderate-to-severe ulcerative colitis (UC). The results showed that
patients treated with mirikizumab achieved significantly greater
rates of clinical remission at 12 weeks compared to placebo.
Detailed results from the Phase 2 trial will be presented today in
a late-breaking abstract session at Digestive Disease Week (DDW) in
Washington, D.C.
"We are proud to present these Phase 2 results for mirikizumab
at DDW, which represent the first public disclosure of data on the
safety and efficacy of an IL-23p19 monoclonal antibody in patients
with moderate-to-severe UC," said Lotus Mallbris, M.D., vice
president, immunology platform team leader, Lilly Bio-Medicines.
"These positive data affirm our confidence in the potential for
mirikizumab to be an option for people living with immune-mediated
diseases looking for a treatment that addresses their life-altering
symptoms. We look forward to advancing our Phase 3 clinical
development program for mirikizumab in UC, in addition to
continuing our ongoing Phase 3 trial for mirikizumab in
moderate-to-severe plaque psoriasis."
The Phase 2 study evaluated the safety and efficacy of
mirikizumab compared to placebo in patients with moderate-to-severe
UC who had previously failed conventional or biologic therapy. In
the study, patients were randomized to receive either mirikizumab
(50 mg or 200 mg with the possibility of exposure-based increases
up to 600 mg, or 600 mg fixed dose) or placebo. The primary and
secondary endpoints at 12 weeks were the percentages of patients
treated with mirikizumab achieving clinical remission, clinical
response, endoscopic healing, endoscopic remission and symptomatic
remission.
At 12 weeks, patients achieved the following response rates:
- Clinical remission: Across all doses studied, between
11.5 percent to 22.6 percent of patients treated with mirikizumab
achieved clinical remission, compared to 4.8 percent of those
treated with placebo (nominal p-value < 0.05 for 200 mg
dose-adjusted group compared with placebo; other treatment group
comparisons yielded non-significant p-values)
- Clinical response: Across all doses studied, between
41.3 percent to 59.7 percent of patients treated with mirikizumab
achieved clinical response, compared to 20.6 percent of those
treated with placebo (nominal p-value < 0.05 for all mirikizumab
groups compared with placebo)
- Endoscopic healing: Across all doses studied, between
13.1 percent to 30.6 percent of patients treated with mirikizumab
achieved endoscopic healing, compared to 6.3 percent of those
treated with placebo (nominal p-value < 0.05 for 50 mg and 200
mg dose-adjusted groups compared with placebo; other treatment
group comparison yielded non-significant p-value)
Additionally, greater proportions of patients treated with
mirikizumab achieved endoscopic remission and symptomatic remission
compared to placebo at 12 weeks. The proportion of patients
achieving endoscopic remission was not statistically
significant.
The incidence of serious adverse events and treatment-emergent
adverse events (TEAEs) was similar across treatment groups. Among
the most common TEAEs reported across all treatment groups, rates
of nasopharyngitis, anemia and headache were similar between
mirikizumab and placebo groups; a greater proportion of patients
reported worsening of ulcerative colitis in the placebo group
compared to patients in the mirikizumab groups.
"I am particularly encouraged by the symptomatic response and
remission data we've seen thus far, and look forward to having data
from later periods in the study to provide insight about the degree
to which endoscopy results continue to improve over time, as we've
observed in other clinical programs for UC," said William J. Sandborn, M.D., Chief, Division of
Gastroenterology, Professor of Medicine at the University of California San Diego School of
Medicine. "Data from this Phase 2 trial indicate that if approved,
mirikizumab may be an effective treatment option for patients with
moderate-to-severe UC."
About Mirikizumab
Mirikizumab is a humanized IgG4
monoclonal antibody that binds to the p19 subunit of interleukin
23. Mirikizumab is being studied for the treatment of immune
diseases, including psoriasis, ulcerative colitis and Crohn's
disease.
About Ulcerative Colitis
Ulcerative colitis (UC) is a
chronic inflammatory bowel disease that affects the
colon.1 UC occurs when the immune system sends white
blood cells into the lining of the intestines, where they produce
chronic inflammation and ulcerations.1 UC affects
millions of patients globally.2 Early and sustained
symptom relief, improvement in the appearance of the mucosa, and
clinical remission are important treatment goals for healthcare
providers and patients.2 There is an unmet need for
treatment options for UC that provide meaningful symptom relief and
deliver sustained clinical remission.
About the Mirikizumab Phase 2 Trial in UC
The Phase
2, multi-center, randomized, double-blind, placebo-controlled trial
was designed to evaluate the safety and efficacy of mirikizumab in
patients with moderate-to-severe UC. The primary endpoint in the
study was the percentage of patients achieving clinical remission
at 12 weeks, as defined by a Mayo rectal bleeding subscore of 0; a
stool frequency subscore of 0 or 1, plus a decrease ≥1 from
baseline; and an endoscopy subscore of 0 or 1. The study also
evaluated secondary endpoints, including clinical response, as
defined by a Mayo subscore decrease of ≥2 points and a ≥35 percent
change in from induction baseline, excluding PGA; endoscopic
healing, as defined by a Mayo endoscopy subscore of 0 or 1;
endoscopic remission, as defined by a Mayo endoscopy subscore of 0;
and symptomatic remission, as defined by a stool frequency subscore
of 0 or 1 and a rectal bleeding subscore of 0. For additional
information on this trial, please visit
clinicaltrials.gov.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with
discovery to make life better for people around the world. We were
founded more than a century ago by a man committed to creating
high-quality medicines that meet real needs, and today we remain
true to that mission in all our work. Across the
globe, Lilly employees work to discover and bring
life-changing medicines to those who need them, improve the
understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us
at www.lilly.com and www.lilly.com/newsroom/social-channels. P-LLY
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about mirikizumab as a potential treatment for patients with
ulcerative colitis, psoriasis and Crohn's disease, and
reflects Lilly's current belief. As with any pharmaceutical
product, there are substantial risks and uncertainties in the
process of development and commercialization. Among other things,
there can be no guarantee that future study results will be
consistent with the results to date, that mirikizumab will receive
regulatory approvals, or be commercially successful. For further
discussion of these and other risks and uncertainties, see Lilly's
most recent Form 10-K and Form 10-Q filings with the United States
Securities and Exchange Commission. Except as required by law,
Lilly undertakes no duty to update forward-looking statements to
reflect events after the date of this release.
1 What is Ulcerative Colitis? Crohn's and Colitis
Foundation Website.
http://www.crohnscolitisfoundation.org/what-are-crohns-and-colitis/what-is-ulcerative-colitis/.
Accessed June 5, 2018.
2 Adelphi Data 2017.
Refer
to:
|
Danielle Neveles,
danielle.neveles@lilly.com; 317-796-4564 (Lilly media)
|
|
Brianna Wilkins;
brianna.wilkins@edelman.com; 312-375-7495 (Media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (Lilly investors)
|
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SOURCE Eli Lilly and Company