INDIANAPOLIS, May 15, 2018 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today that galcanezumab met its
primary endpoint in a Phase 3 study of patients with episodic
cluster headache, demonstrating statistically significant
differences in the reduction of weekly cluster headache attacks
compared to placebo across weeks one to three of the two-month,
double-blind treatment period. A statistically significantly
greater percentage of patients treated with galcanezumab also
achieved at least a 50 percent reduction in weekly cluster headache
attacks compared to placebo at Week 3, the gated secondary
endpoint.
The observed safety and tolerability profile was consistent with
previous studies that evaluated galcanezumab for the prevention of
migraine. In this study, 8 percent of patients treated with
galcanezumab discontinued treatment during the study compared to 21
percent of patients treated with placebo. Four percent of patients
treated with galcanezumab discontinued treatment during the study
due to adverse events compared to 2 percent of patients treated
with placebo. Discontinuations due to lack of efficacy occurred in
2 percent of patients treated with galcanezumab, compared to 14
percent of patients treated with placebo.
"Cluster headache can be difficult to evaluate in clinical
studies, which has contributed to few available treatment options
for cluster headache, often considered the most severe pain one can
experience," said Christi Shaw,
president of Lilly Bio-Medicines. "The positive results in episodic
cluster headache are truly a landmark moment—both for people living
with cluster headache and for our researchers at Lilly, many of
whom have spent more than two decades researching and developing
innovative, non-opioid treatment options for diseases like migraine
and cluster headache."
Lilly also conducted a separate Phase 3 study for patients with
chronic cluster headache, which represents 10 to 15 percent of
cluster headache cases.1 This study did not meet its
primary endpoint.
Based on results from the episodic cluster headache trial, Lilly
is working with regulatory agencies around the world to determine
the best path forward. Episodic cluster headache represents 85 to
90 percent of cluster headache cases.1
These studies, which evaluated a combined 343 patients, are the
largest controlled preventive trials conducted in cluster headache
to date.
"It is hard to articulate the devastating impact that cluster
headache can have on those of us living with the disease. Many
people living with cluster headache spend years searching for
effective treatment options to help ease an excruciating level of
pain," said Bob Wold, a patient
living with cluster headache and founder of Clusterbusters, Inc.
"We are very excited by these results and galcanezumab's potential
as a new treatment option for people living with cluster headache,
many of whom have spent years feeling ignored and alone in their
struggle."
Episodic Cluster Headache Study Results
The episodic
cluster headache study included a two-month treatment period
comparing galcanezumab to placebo. Patients with episodic cluster
headache treated with galcanezumab (300 mg once-monthly)
experienced statistically significant differences in the reduction
of weekly cluster headache attacks compared to patients treated
with placebo across weeks one to three of the two-month,
double-blind treatment period (-8.7 for galcanezumab compared to
-5.2 for placebo, p=0.036), the primary endpoint of the study.
In May 2017, Lilly announced
positive data from three Phase 3 studies (EVOLVE-1, EVOLVE-2 and
REGAIN) evaluating galcanezumab for the treatment of chronic and
episodic migraine. In these studies, galcanezumab demonstrated
statistically significant reductions in the number of monthly
migraine headache days compared to placebo at both studied doses
(120 mg and 240 mg once-monthly).
The FDA is currently reviewing galcanezumab for the prevention
of migraine in adults. A decision is expected in the third quarter
of 2018.
About the Phase 3 Studies
The episodic cluster
headache study was a two-month Phase 3, randomized, double-blind,
placebo-controlled global trial evaluating the safety and efficacy
of galcanezumab (300 mg once-monthly) administered subcutaneously
compared with placebo in 106 patients with episodic cluster
headache. Patients who participated in this trial had an average of
17.5 cluster headache attacks per week at baseline. The primary
endpoint was the overall mean change from baseline in weekly
cluster headache attack frequency across weeks one to three with
galcanezumab compared with placebo.
The chronic cluster headache study was a three-month Phase 3,
randomized, double-blind, placebo-controlled global trial
evaluating the safety and efficacy of galcanezumab (300 mg
once-monthly) administered subcutaneously compared with placebo in
237 patients with chronic cluster headache. Patients who
participated in this trial had an average of 18.8 cluster headache
attacks per week at baseline. The primary endpoint was the overall
mean change from baseline in weekly cluster headache attack
frequency during the three-month, double-blind treatment phase with
galcanezumab compared with placebo. In this study, patients who
completed the three-month double-blind period could choose to enter
an ongoing 12-month, open-label extension phase and receive
galcanezumab during that time.
About Cluster Headache
Cluster headache is an
uncommon, disabling headache disorder composed of recurrent
"attacks" of intense headaches on one side of the head, frequently
associated with pain behind or around one eye, restlessness and
agitation.1,2 Cluster headache attacks typically last
between 15 to 180 minutes, occurring near daily to multiple times
daily during a cluster period.1 It is estimated that 85
to 90 percent of cluster headache cases are classified as
"episodic" with attacks occurring in periods that last from seven
days to one year, separated by pain-free remission periods of one
month or longer.1 The remaining 10 to 15 percent
are classified as "chronic" with attacks occurring for more than
one year without a remission period, or with remission lasting less
than one month.1
About Galcanezumab
Galcanezumab is a monoclonal
antibody specifically designed to bind to and reduce the
overactivity 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 Lilly's Commitment to Headache Disorders
For
over 25 years, Lilly has been committed to helping people suffering
from headache disorders, investigating more than a dozen different
compounds for the treatment of migraine, cluster headache and other
disabling headache disorders. These research programs have
accelerated the understanding of these diseases and furthered the
advancement of Lilly's comprehensive late-stage development
programs studying galcanezumab for prevention of migraine and
cluster headache, and lasmiditan for the acute treatment of
migraine. Our goal is to make life better for people with headache
disorders by offering comprehensive solutions to prevent or stop
these disabling diseases. 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 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
cluster headache and migraine 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 or that galcanezumab will 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.
1 Headache Classification Committee of the
International Headache Society (IHS). The international
classification of headache disorders, 3rd edition.
Cephalalgia. 2013;33(9):629-808.
2 Matharu M, Goadsby P. Trigeminal autonomic cephalgias.
Journal of Neurology, Neurosurgery, and Psychiatry.
2002;72(Suppl II):ii19-ii26.
Refer to: Jen Dial;
dial_jennifer_kay@lilly.com; 317-220-1172 (Lilly Bio-Medicines)
Kevin
Hern; hern_kevin_r@lilly.com; 317-277-1838 (Investor
Relations)
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