INDIANAPOLIS, June 10, 2017 /PRNewswire/ -- Eli Lilly
and Company (NYSE: LLY) announced today positive results from three
Phase 3 studies of galcanezumab, an investigational treatment for
the prevention of episodic and chronic migraine, including
late-breaking data on several key secondary endpoints for
galcanezumab compared to placebo at both studied doses. Detailed
results from these studies (EVOLVE-1, EVOLVE-2 and REGAIN) will be
presented today at the American Headache Society (AHS) annual
scientific meeting in Boston.
"The detailed Phase 3 results presented today represent a
crucial step forward for the millions of patients living with
migraine who have not yet tried, or found, an effective preventive
therapy," said Christi Shaw,
president of Lilly Bio-Medicines. "Following more than 25 years of
research in migraine, Lilly is excited to help usher in a new era
of preventive migraine therapies that may substantially improve the
current standard of care for people living with
migraine."
The observed safety and tolerability profile was consistent with
findings from previous studies of galcanezumab. In these three
studies, the most commonly-reported adverse events were injection
site reactions.
Based on these results, Lilly will submit a Biologics License
Application to the U.S. Food and Drug Administration (FDA) for
galcanezumab in the second half of 2017, followed by submissions to
other regulatory agencies around the world.
EVOLVE-1 and EVOLVE-2 Study Results
In both studies,
over the six-month treatment period, patients with episodic
migraine treated with galcanezumab 120 mg and 240 mg doses
experienced a statistically significantly greater decrease in the
average number of monthly migraine headache days compared to
patients treated with placebo, with statistically significant
improvements observed at each month starting at one month of
treatment.
A statistically significantly greater percentage of patients
treated with both doses of galcanezumab achieved at least a 50
percent, 75 percent and 100 percent reduction in the number of
migraine headache days compared to placebo over the six-month
treatment period, in both studies after multiplicity
adjustment.
EVOLVE-1:
- At least a 50 percent reduction: 62.3% for 120 mg and 60.9% for
240 mg compared to 38.6% for placebo, p<0.001 for both dosing
groups
- At least a 75 percent reduction: 38.8% for 120 mg and 38.5% for
240 mg compared to 19.3% for placebo, p<0.001 for both dosing
groups
- 100 percent reduction: 15.6% for 120 mg and 14.6% for 240 mg
compared to 6.2% for placebo, p<0.001 for both dosing
groups
EVOLVE-2:
- At least a 50 percent reduction: 59.3% for 120 mg and 56.5% for
240 mg compared to 36.0% for placebo, p<0.001 for both dosing
groups
- At least a 75 percent reduction: 33.5% for 120 mg and 34.3% for
240 mg compared to 17.8% for placebo, p<0.001 for both dosing
groups
- 100 percent reduction: 11.5% for 120 mg and 13.8% for 240 mg
compared to 5.7% for placebo, p<0.001 for both dosing
groups
Patients treated with galcanezumab in both studies also had a
statistically significantly greater reduction of monthly migraine
headache days with acute medication use compared to placebo over
the six-month treatment period after multiplicity adjustment.
- EVOLVE-1: An average reduction of 4.0 days for 120 mg and 3.8
days for 240 mg compared to 2.15 days for placebo, p<0.001 for
both dosing groups
- EVOLVE-2: An average reduction of 3.7 days for 120 mg and 3.6
days for 240 mg compared to 1.85 days for placebo, p<0.001 for
both dosing groups
Patients treated with both doses of galcanezumab also saw
statistically significant improvement in physical function compared
to placebo over the six-month treatment period, as measured by both
the Role Function-Restrictive (RF-R) domain score of the
Migraine-Specific Quality of Life Questionnaire (MSQ) and the
Patient Global Impression of Severity (PGI-S) rating after
multiplicity adjustment.
REGAIN Study Results
Over the three-month treatment
period, patients with chronic migraine treated with galcanezumab
120 mg and 240 mg doses experienced a statistically significantly
greater decrease in the average number of monthly migraine headache
days compared to patients treated with placebo. Statistically
significant improvements for both doses of galcanezumab were
observed at each month starting at one month of treatment.
A statistically significantly greater percentage of patients
also achieved at least a 50 percent reduction in the number of
migraine headache days compared to placebo over the three-month
treatment period (27.6% for 120 mg and 27.5% for 240 mg compared to
15.4% for placebo, p<0.001 for both dosing groups) after
multiplicity adjustment.
Compared with placebo over the three-month treatment period, a
statistically significantly higher percentage of patients treated
with the 240 mg dose of galcanezumab achieved at least a 75 percent
reduction in the number of migraine headache days (8.8% compared to
4.5% for placebo, p<0.001) after multiplicity adjustment.
Patients treated with the 240 mg dose of galcanezumab also achieved
a statistically significantly greater reduction in the number of
monthly migraine headache days with acute medication use compared
to placebo over the three-month treatment period (an average of 4.3
days compared to 2.2 days for placebo, p<0.001) after
multiplicity adjustment.
Patients treated with 240 mg of galcanezumab also saw
statistically significant improvement in physical function compared
to placebo over the three-month treatment period, as measured by
both the RF-R domain score of the MSQ and PGI-S rating after
multiplicity adjustment.
Lilly will submit these findings for publication in
peer-reviewed journals in the coming year.
About the EVOLVE-1 and EVOLVE-2 Studies
EVOLVE-1 and
EVOLVE-2 are six-month Phase 3, randomized, double-blind,
placebo-controlled global trials evaluating the safety and efficacy
of two doses of galcanezumab administered subcutaneously (120 mg or
240 mg once-monthly, following a 240 mg starting dose) compared
with placebo in 1,773 patients with episodic migraine (858 patients
in EVOLVE-1 and 915 patients in EVOLVE-2). To be eligible for the
trials, patients must have experienced between four and 14 migraine
headache days per month. Patients that participated in these trials
had an average of 9.1 migraine headache days per month at baseline.
The primary endpoint was the mean change from baseline in monthly
migraine headache days over the six-month, double-blind treatment
phase.
About the REGAIN Study
REGAIN is a three-month Phase
3, randomized, double-blind, placebo-controlled global trial
evaluating the safety and efficacy of two doses of galcanezumab
administered subcutaneously (120 mg or 240 mg once-monthly,
following a 240 mg starting dose) compared with placebo in 1,113
patients with chronic migraine. To be eligible for the trial,
patients must have experienced at least 15 headache days per month,
of which at least eight met criteria for migraine. Patients that
participated in the trial had an average of 19.4 migraine headache
days per month at baseline. The primary endpoint was the mean
change from baseline in monthly migraine headache days over the
three-month, double-blind treatment phase. In REGAIN, galcanezumab
was further evaluated for an additional nine months of an
open-label extension phase following the three-month, double-blind
treatment phase.
About Migraine
Migraine is a disabling neurological
disease characterized by recurrent episodes of severe headache, and
is often accompanied by other symptoms including nausea, vomiting,
sensitivity to light and sound, and changes in
vision.i,ii
More than 38 million Americans have migraine, with three times more
women affected by migraine compared to
men.iii Of the approximately
40 percent of patients suffering from migraine for whom prevention
is appropriate, only 13 percent are currently receiving
therapy.iv,v,
vi Results from the Second International
Burden of Migraine study show that side effects of treatment play a
role in this disconnect, with up to 53 percent of respondents
discontinuing migraine prevention therapy because of side
effects.vii According to the Migraine
Research Foundation, healthcare and lost productivity costs
associated with migraine are estimated to be as high as
$36 billion annually in the U.S., yet
it remains under-recognized and under-treated.3,7
About Lilly in Migraine
Lilly has been committed to
helping people suffering from migraine for over 25 years,
investigating more than a dozen different compounds for the
treatment of headache disorders. These research programs have
accelerated understanding of this disease and advanced the
development of Lilly's comprehensive late-stage development
programs studying galcanezumab for prevention of migraine and
lasmiditan for the acute treatment of migraine. Our goal is to make
life better for people with migraine by offering comprehensive
solutions to prevent or stop this disabling disease. The combined
clinical, academic and professional experience of our experts helps
us to build our research portfolio, identify challenges for
healthcare providers and pinpoint the needs of patients living with
migraine and cluster headache.
About Galcanezumab
Galcanezumab is a monoclonal
antibody specifically designed to bind to and inhibit the activity
of calcitonin gene-related peptide (CGRP), which is believed to
play a role in migraine and cluster headache. Galcanezumab is an
investigational once-monthly, self-administered injection under
evaluation for the prevention of migraine and cluster headache.
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 galcanezumab as a potential treatment for patients with
chronic and episodic migraine and cluster headache, and reflects
Lilly's current belief. However, 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 galcanezumab will achieve
its primary study endpoints or receive regulatory approvals.
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.
Refer to:
|
Jen Dial;
dial_jennifer_kay@lilly.com; +1-317-220-1172 (media)
|
|
Phil Johnson;
johnson_philip_l@lilly.com; +1-317-655-6874
(investors)
|
___________________________
i Headache disorders. World Health
Organization website.
http://www.who.int/mediacentre/factsheets/fs277/en/. Accessed
May 24, 2017.
ii Russo AF. Calcitonin gene-related peptide
(CGRP): a new target for migraine. Annual Review of Pharmacology
and Toxicology. 2015;55:533-552.
iii Migraine facts. Migraine Research
Foundation website.
http://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed May 24, 2017.
iv Lipton RB, Bigal ME, Diamond M, et al.
Migraine prevalence, disease burden and the need for preventive
therapy. Neurology. 2007;68(5):343-349.
v Lafata, JE, Tuniceli O, Cerghet M, et al.
The use of migraine preventive medications among patients with and
without migraine headaches. Cephalagia.
2010;30(1):97-104.
vi Diamond S, Bigal ME, Silberstein S, et al.
Patterns of diagnosis and acute and preventive treatment for
migraine in the United States:
results from the American Prevalence and Prevention study.
Headache. 2007;47(3):355-363.
vii Blumenfeld AM, Bloudek LM, Becker WJ, et
al. Patterns of use and reasons for discontinuation of prophylactic
medications for episodic migraine and chronic migraine: results
from the Second International Burden of Migraine Study (IBSM-II).
Headache. 2013;53(4):644-655.
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