INDIANAPOLIS, April 20, 2018 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today it will present Phase 3 data
for galcanezumab and lasmiditan, two investigational treatments for
migraine, at the American Academy of Neurology (AAN) annual meeting
taking place April 21-27 in
Los Angeles.
Lilly will highlight a new analysis from three Phase 3 studies
(EVOLVE-1, EVOLVE-2 and REGAIN) evaluating galcanezumab in patients
who previously failed two or more preventive therapies as part of
the "Best in Headache" platform session on Tuesday, April 24. Lilly will also present data
from two pivotal Phase 3 studies (SAMURAI and SPARTAN) side-by-side
evaluating the safety and efficacy of lasmiditan for the acute
treatment of migraine.
Galcanezumab is a once-monthly, self-administered calcitonin
gene-related peptide (CGRP) antibody currently under review by the
U.S. Food and Drug Administration (FDA) for the prevention of
migraine in adults. Lasmiditan is an investigational, oral,
first-in-class molecule that could represent the first
significant innovation for the acute treatment of migraine in more
than two decades.
Galcanezumab and lasmiditan represent two of three
investigational, non-opioid treatments in development as part of
Lilly's overall pain portfolio. The portfolio also includes
tanezumab, developed in partnership with Pfizer, for the treatment
of osteoarthritis pain, chronic low back pain and cancer pain.
"Like other recurrent and chronic pain conditions, migraine has
a significant impact on a person's physical, social and economic
well-being, yet there remains both a stigma and an unmet need for
treatment options for this debilitating disease," said Robert Conley, M.D., Distinguished Lilly Scholar
and Lilly global development leader for migraine therapeutics. "The
data to be presented at AAN reflect Lilly's decades-long commitment
to the development of new, innovative therapies in migraine, and
reinforces the potential for galcanezumab and lasmiditan to address
one of the biggest challenges in pain management today."
Studies, as well as the dates and times of the data sessions,
are highlighted below.
Oral Presentations:
Tuesday, April 24, 2018 – 8:24 –
8:32 a.m. PT
- S20.004: Efficacy of Galcanezumab in Patients Who Failed to
Respond to Preventives Previously: Results from EVOLVE-1, EVOLVE-2
and REGAIN Studies
-
- Presenter: Sheena Aurora , M.D.,
medical fellow and global launch leader, galcanezumab, Eli Lilly
and Company, Indianapolis, IN
Wednesday, April 25, 2018 – 1:00 –
3:00 p.m. PT
- S32.003: In Vitro Characterization of Agonist Binding and
Function Activity at a Panel of Serotonin Receptor Subtypes for
Lasmiditan, Triptans and Other 5-HT Receptor Ligands and Activity
Relationships for Contraction of Human Isolated Cornary
Artery
-
- Presenter: Antoinette MaassenVanDenBrink, associate professor,
Division of Vascular Medicine and Pharmacology, Department of
Internal Medicine, Erasmus University
Medical Center, Rotterdam, The
Netherlands
- S32.008: Lasmiditan Inhibits CGRP Release in the Mouse
Trigeminovasular System
-
- Presenter: Antoinette MaassenVanDenBrink, associate professor,
Division of Vascular Medicine and Pharmacology, Department of
Internal Medicine, Erasmus University
Medical Center, Rotterdam, The
Netherlands
Friday, April 27, 2018 – 2:24 –
2:36 p.m. PT
- S50.008: Phase 3 Studies (SAMURAI, SPARTAN) of Lasmiditan
Compared to Placebo for Acute Treatment of Migraine
-
- Presenter: Eric Pearlman, M.D.,
medical fellow, Eli Lilly and Company, Indianapolis, IN
About Migraine
Migraine is a neurological disease characterized by recurrent
episodes of severe headache accompanied by other symptoms including
nausea, vomiting, sensitivity to light and sound, and changes in
vision.1,2
More than 36 million Americans have migraine, with three times more
women affected by migraine compared to
men.3 According to the
Medical Expenditures Panel Survey, total annual healthcare costs
associated with migraine are estimated to be as high as
$56 billion annually in the United States, yet it remains
under-recognized and under-treated.4
About Lilly in Migraine
For over 25 years, Lilly has been committed to helping people
suffering from migraine, investigating more than a dozen different
compounds for the treatment of migraine and disabling 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 cluster headache, 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 disabling migraine attacks. 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 Lasmiditan
Lasmiditan is an investigational, first-in-class molecule under
evaluation for the acute treatment of migraine. Lasmiditan
selectively targets 5-HT1F receptors expressed in the
trigeminal pathway, and has been designed for the acute treatment
of migraine without the vasoconstrictor activity associated with
some migraine therapies. In March
2017, Lilly completed the acquisition of CoLucid
Pharmaceuticals, including lasmiditan, which was originally
discovered at Lilly.
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
migraine and cluster headache; lasmiditan as a potential treatment
for patients with migraine; and tanezumab as a potential treatment
for patients with osteoarthritis pain, chronic low back pain, and
cancer pain; 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 or lasmiditan will achieve their 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; 317-220-1172 (Lilly
Bio-Medicines)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (Investor
Relations)
|
1 Katsarava Z, Buse D, Manack A, et al.
Defining the differences between episodic migraine and chronic
migraine. Current Pain Headache Reports.
2012;16:86.
2 Blumenfeld AM, Payne KA, Varon SF, et al.
Disability, HRQOL, and resource use amongst chronic and episodic
migraineurs. Results from the International Burden of Migraine
Study (IBMS). Cephalalgia 2011;31:301..
3 Identifying and treating migraine. American
Migraine Foundation website.
https://americanmigrainefoundation.org/understanding-migraine/identifying-treating-migraine/.
Last accessed April 19, 2018.
4 Raval AD, Shah A. National trends in direct
health care expenditures among US adults with migraine: 2004 to
2013. Journal of Pain. 2017;57:60.
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SOURCE Eli Lilly and Company