INDIANAPOLIS, July 22, 2015 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced results suggesting the
treatment effect of solanezumab was preserved within a
pre-specified amount in patients with mild Alzheimer's disease who
received solanezumab earlier in the disease compared to patients
who began treatment at a later point. These results were from a
pre-specified secondary analysis of the Phase 3 EXPEDITION,
EXPEDITION2 and EXPEDITION-EXT studies, and were presented today at
the Alzheimer's Association International Conference®
2015 (AAIC®) in Washington,
D.C.1, 2 These results support the use of the
"delayed-start" method for assessing the potential effects of a
treatment on the underlying disease progression of Alzheimer's
disease.1 Results from this study are expected to be
published online today in Alzheimer's & Dementia:
Translational Research & Clinical Interventions.
"We are particularly excited about these data because this is
the first time the delayed-start methodology has been implemented
for an Alzheimer's disease clinical trial," said Hong Liu-Seifert, Ph.D., study research advisor
at Eli Lilly and Company. "This new analytical method enabled us to
assess if solanezumab had an effect that is consistent with slowing
progression of disease by modifying the underlying disease
progression, which, up until now, has not been studied. These
results support the trial design and delayed-start analysis plan of
EXPEDITION3, which is expected to have the last patient visit in
October 2016."
The objective of the delayed-start analysis was to assess a
possible disease-modifying effect of solanezumab in patients with
mild Alzheimer's disease. These results were obtained from a
pre-specified secondary analysis of the Phase 3 EXPEDITION,
EXPEDITION2 and EXPEDITION-EXT studies. EXPEDITION and EXPEDITION2
had identical study protocols, which included an 18-month
randomized, double-blind, placebo-controlled period, after which a
two-year delayed-start period occurred (EXPEDITION-EXT), where the
placebo-treated patients from the placebo-controlled period began
treatment with solanezumab. Results from EXPEDITION and EXPEDITION2
were pooled and only patients with mild dementia at the beginning
of the study were included in this analysis. During the
delayed-start period, the original treatment assignment remained
blinded to patients and sites. When considering the
placebo-controlled period and delayed-start period together, all
patients were randomized to the same active treatment (solanezumab)
but starting at different times, resulting in two treatment
regimens: early-start and delayed-start. The primary analysis was
at 108 weeks after the beginning of the placebo-controlled period
(28 weeks after the beginning of the delayed-start period) among
the subgroup of patients with mild Alzheimer's disease at baseline.
To assess whether the benefits of early treatment can be matched by
later treatment (that is, whether delayed-start patients can "catch
up" with early-start patients), a noninferiority test was
conducted.1
Key Results Highlights:1
- Treatment differences in cognition and function between
early-start and delayed-start groups at the end of the
placebo-controlled period (80 weeks since randomization) were
preserved at the primary time point of 108 weeks (28 weeks after
the start of EXPEDITION-EXT) within a pre-defined margin. This
difference at 108 weeks remained statistically significant.
- Treatment differences in cognition and function between
early-start and delayed-start groups at the end of the
placebo-controlled period (80 weeks since randomization) were also
preserved at an additional time point of 132 weeks (52 weeks after
the start of EXPEDITION-EXT) within a pre-defined margin. This
difference at 132 weeks was statistically significant.
Analysis Methods1
A total of
1,322 subjects with mild Alzheimer's disease were randomized to
either the delayed-start (n=663) or to the early-start (n=659)
groups. Of the 1,024 subjects who completed the placebo-controlled
period (pooled EXPEDITION and EXPEDITION2), 95.2 percent (n=975)
entered the delayed-start period (EXPEDITION-EXT), and 58.2 percent
of delayed-start (n=286) and 61.0 percent of early-start patients
(n=295) completed two years in the delayed-start period.
Researchers tested the hypothesis of a potential disease-modifying
effect of solanezumab using a delayed-start analysis, which applied
a noninferiority test framework to determine if the delayed-start
patients caught up with the early-start patients.
About Solanezumab
Solanezumab is Lilly's Phase
3 monoclonal antibody being studied as a potential therapy for
patients with mild Alzheimer's disease. Solanezumab binds to
soluble monomeric forms of amyloid-beta after it is produced,
allowing it to be cleared before it clumps together to form
beta-amyloid plaques.
About Alzheimer's Disease
Alzheimer's disease is a
fatal illness that causes progressive decline in memory and other
aspects of cognition. It is the most common form of dementia,
accounting for 60 to 80 percent of dementia cases.3
There are currently an estimated 44 million people living with
dementia worldwide.4 The number of people affected by
dementia is expected to be more than 75 million in 2030 and 135
million in 2050.4 Estimates vary, but experts suggest
that as many as 5.3 million Americans may have Alzheimer's
disease.3
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
newsroom.lilly.com/social-channels. P-LLY
Lilly Forward-Looking Statement
This press release contains certain forward-looking statements
about solanezumab, an anti-amyloid monoclonal antibody in clinical
testing for treatment of Alzheimer's disease. This release reflects
Lilly's current beliefs; however, as with any pharmaceutical
product, there are substantial risks and uncertainties in the
process of development and commercialization. There is no guarantee
that future study results and patient experience will be consistent
with study findings to date or that solanezumab will be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements.
1 Liu-Seifert H, Siemers E, Holdrige K, Andersen S,
et al. Delayed-Start of up to 3.5 Years in the Phase 3 Solanezumab
Expedition Program in Mild Alzheimer's Disease. Presented at
Alzheimer's Association International Conference (AAIC) 2015,
July 18-23, 2015.
2 Doody, R., Thomas, R.G., Farlow, M., Iwatsubo, T., et
al. (2014). Phase 3 Trials of Solanezumab for Mild-to-Moderate
Alzheimer's Disease. The New England Journal of Medicine,
370, 311-321. doi: 10.1056/NEJMoa1312889
3 Alzheimer's Association. 2015 Alzheimer's Disease
Facts and Figures. Alzheimer's & Dementia
2015;11(3)332+.
4 Alzheimer's Disease International and World Health
Organization Dementia Statistics. Available at:
http://www.alz.co.uk/research/statistics. Accessed May 27, 2015.
Refer to: Nicole
Hebert; hebert_nicole@lilly.com; 317.701.9984
(Lilly)
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