INDIANAPOLIS, Oct. 12, 2020 /PRNewswire/ -- Eli Lilly and
Company (NYSE:LLY) announced today new efficacy and safety data
from the Phase 2 SERENITY study evaluating mirikizumab in patients
with moderately to severely active Crohn's disease, a form of
inflammatory bowel disease (IBD) that can cause systemic
inflammation manifested as abdominal pain, diarrhea, fever, weight
loss and lead to intestinal obstruction, fibrosis and other
complications. SERENITY included a 12-week induction period and
40-week continued treatment period, which evaluated the safety and
efficacy of multiple dosing regimens and two methods of
administration through Week 52 as measured by
endoscopic response, which reflects substantial reduction in
inflammation of the lining of the bowel as seen during an
endoscopy, and by Patient Reported Outcomes (PRO) remission, two
important treatment goals in Crohn's disease. Detailed results
from the trial are being presented virtually today in an abstract
session at the United European Gastroenterology Week (UEG Week)
2020.
In the induction period, patients were randomized across four
treatment arms to receive placebo or one of three doses of
mirikizumab intravenously. At 12 weeks, patients who showed
endoscopic improvement were randomized to continue mirikizumab
treatment, administered either intravenously or subcutaneously.
Patients who did not show endoscopic improvement or who had been
randomized to the placebo arm in induction were assigned to receive
mirikizumab treatment intravenously.
In the continued treatment period of the study, patients
achieved key secondary outcomes at Week 52 including endoscopic
response (defined as at least 50% reduction from baseline in Simple
Endoscopic Score for Crohn's Disease [SES-CD]), PRO remission
(defined as an average daily stool frequency of ≤2.5 and abdominal
pain ≤1 and no worse than baseline) and endoscopic remission
(defined as achieving an SES-CD score <4 for ileal-colonic
disease or <2 for isolated ileal disease, and no subscore
>1).
- Endoscopic response: Nearly 60% of patients achieved
endoscopic response (58.5% in the randomized IV dosing group and
58.7% in the SC group).
- PRO remission: More than 45% of patients achieved PRO
remission (46.3% in the IV group and 45.6% in the SC group).
"Crohn's disease is a serious and difficult-to-treat condition,
and there is a significant need for additional treatments. I am
encouraged by the results of this study, which showed response in
both symptom relief and endoscopic response and remission at 52
weeks of treatment with mirikizumab," said Bruce E. Sands, MD, MS, Dr. Burrill B. Crohn
Professor of Medicine, Chief of the Dr. Henry D. Janowitz Division
of Gastroenterology at the Icahn School of Medicine at Mount
Sinai.
Among the subset of patients who achieved endoscopic response at
Week 12, 69.6% and 66.7% in the IV (n=23) and SC (n=24) groups,
respectively, also had endoscopic response at Week 52.
Additionally, among those with endoscopic remission at Week 12,
50.0% and 64.3% in the IV (n=6) and SC (n=14) groups, respectively,
also had endoscopic remission at Week 52.
"People who live with moderate to severe Crohn's disease need
additional treatment options and are looking for innovative
therapies that can address their challenging and painful symptoms,"
said Lotus Mallbris, M.D., Ph.D., vice president of immunology
development at Lilly. "With these encouraging Phase 2 results, we
look forwarding to continuing our clinical program for mirikizumab
with the hope that we can provide help for those living with
Crohn's disease."
One patient in each group among those who showed endoscopic
improvement at Week 12 discontinued due to an adverse event (AE).
Similar frequencies of treatment-emergent AEs and serious AEs were
reported in IV and SC groups. The most common treatment-emergent
AEs reported were nasopharyngitis (4.9% in IV group, 13% in SC
group), headache (7.3% in IV group, 8.7% in SC group) and
arthralgia (joint pain) (7.3% in IV group, 13% in SC
group).
At UEG Week, Lilly also virtually presented additional results
for mirikizumab from the Phase 2 Crohn's disease study as well as
data on bowel urgency and quality of life in patients with
ulcerative colitis (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 Crohn's Disease
Crohn's disease, which is a
form of inflammatory bowel disease (IBD), is a chronic
immune-mediated condition of the gastrointestinal (GI) tract.
Crohn's most commonly affects the end of the small bowel (the
ileum) and the beginning of the colon, but it may affect any part
of the GI tract, from the mouth to the anus. IBD, which is
inclusive of Crohn's disease and ulcerative colitis, affects 10
million people worldwide.
About the Mirikizumab Phase 2 Trial in Crohn's
Disease
SERENITY, the Phase 2, multi-center, randomized,
parallel-arm, double-blind, placebo-controlled trial was designed
to assess the safety and efficacy of mirikizumab in patients with
moderately to severely active Crohn's disease. At baseline,
participants were randomized with a 2:1:1:2 allocation across four
treatment arms (mirikizumab 200 mg, mirikizumab 600 mg, mirikizumab
1000 mg, and placebo). The primary endpoint was endoscopic response
as determined by the proportion of participants achieving at least
50 percent reduction from baseline on the Simple Endoscopic Score
for Crohn's Disease (SES-CD) at Week 12. In May 2019, Lilly reported Phase 2 results showing
more patients with moderate to severe Crohn's disease receiving
mirikizumab achieved clinical remission and response at 12 weeks.
Overall, the safety profile at 12 weeks was consistent with that of
mirikizumab in studies of ulcerative colitis and with the
class.
About Lilly in Immunology
Lilly is bringing our
heritage of championing groundbreaking, novel science to immunology
and is driven to change what's possible for people living with
autoimmune diseases. There are still significant unmet needs, as
well as personal and societal costs, for people living with a
variety of autoimmune diseases and our goal is to minimize the
burden of disease. Lilly is investing in leading-edge clinical
approaches across its immunology portfolio in hopes of transforming
the autoimmune disease treatment experience. We've built a deep
pipeline and are focused on advancing cutting edge science to find
new treatments that offer meaningful improvements to support the
people and the communities we serve.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to create
medicines that 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/news. 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 moderate-to-severe plaque psoriasis, Crohn's disease and
ulcerative colitis, 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 undertake no duty to
update forward-looking statements to reflect events after the date
of this release.
Refer
to:
|
Jen Dial,
dial_jennifer_kay@lilly.com; 317-220-1172 (media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (investors)
|
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