INDIANAPOLIS, Aug. 4, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today that lasmiditan, an
investigational, oral, first-in-class molecule for the acute
treatment of migraine, met its primary endpoint in SPARTAN, a
second Phase 3 study. At two hours following the first dose, a
greater percentage of patients treated with lasmiditan were
migraine pain-free compared to placebo. These results were
statistically significant across all three studied doses (50 mg,
100 mg and 200 mg).
Lasmiditan also met the key secondary endpoint for SPARTAN
across all three studied doses, with a statistically significantly
greater percentage of patients free of their most bothersome
symptom (MBS) compared with placebo at two hours following the
first dose. In this study, patients chose their MBS from nausea,
sensitivity to sound or sensitivity to light.
"Lasmiditan represents the first significant innovation in the
acute treatment of migraine in more than 20 years, and could
provide a much-needed new treatment option for the 36 million
Americans living with migraine," said Christi Shaw, president of Lilly Bio-Medicines.
"We are thrilled with these topline lasmiditan results, which add
to more than 25 years of Lilly's research and development of
migraine therapies."
The most commonly-reported adverse events after lasmiditan
dosing were dizziness, paresthesia, somnolence, fatigue, nausea and
lethargy.
These findings are consistent with SAMURAI, the first pivotal
Phase 3 study evaluating the safety and efficacy of lasmiditan for
the acute treatment of migraine. In this study, lasmiditan met both
the primary and key secondary endpoints with statistical
significance. Results from SAMURAI were presented at the American
Headache Society (AHS) annual meeting in June.
Lilly plans to submit a New Drug Application for lasmiditan to
the U.S. Food and Drug Administration (FDA) in the second half of
2018.
SPARTAN Study Results
At two hours following the first dose of lasmiditan, the percentage
of patients who were migraine pain-free was statistically
significantly greater compared to placebo in all dosing groups:
28.6 percent for 50 mg (p=0.003); 31.4 percent for 100 mg
(p<0.001); 38.8 percent for 200 mg (p<0.001) and 21.3 percent
for placebo.
Statistically significantly more patients treated with
lasmiditan were also free of their migraine-associated MBS compared
to placebo at two hours following the first dose: 40.8 percent for
50 mg (p=0.009); 44.2 percent for 100 mg (p<0.001); 48.7 percent
for 200 mg (p<0.001) and 33.5 percent for placebo.
"Lasmiditan has been designed to target receptors associated
with migraine without the vasoconstrictor activity associated with
some migraine therapies," said Robert
Conley, M.D., Distinguished Lilly Scholar and Lilly global
development leader for migraine therapeutics. "We hope these
results are a significant step forward in the development of new
acute migraine treatments for the millions of patients in need,
including those who may be poorly served by existing therapies or
those with cardiovascular disease or risk factors."
Lasmiditan also demonstrated statistically significant
improvements compared to placebo in additional secondary endpoints,
including migraine pain relief and migraine disability.
Lilly will present detailed data from both studies at scientific
meetings and submit the results to peer-reviewed journals within
the next year. An open-label Phase 3 study—GLADIATOR—is also
underway evaluating the long-term safety of lasmiditan for the
acute treatment of migraine.
About the SPARTAN Study
SPARTAN is a Phase 3 randomized, double-blind, placebo-controlled
global trial evaluating the safety and efficacy of three doses of
lasmiditan administered orally (50 mg, 100 mg or 200 mg) compared
with placebo for the acute treatment of migraine. To be eligible
for this trial, patients were required to have at least moderate
migraine disability (as measured by a Migraine Disability
Assessment Score (MIDAS) ≥ 11). Patients that participated in the
trial had an average of more than five migraine attacks per month
at baseline. SPARTAN did not exclude patients with one or more
cardiovascular risk factors or known coronary artery disease. The
primary endpoint of the study was comparison of the percentage of
patients in the lasmiditan 200 mg and placebo groups who were
migraine pain-free at two hours following the first dose. The key
secondary endpoint of the study was comparison of the percentage of
patients in the lasmiditan 200 mg and placebo groups who were free
of their MBS (nausea, sensitivity to sound or sensitivity to light)
at two hours following the first dose.
About the SAMURAI Study
SAMURAI is a Phase 3
randomized, double-blind, placebo-controlled U.S. trial evaluating
the safety and efficacy of two doses of lasmiditan administered
orally (100 mg or 200 mg) compared with placebo for the acute
treatment of migraine. To be eligible for the trial, patients were
required to have at least moderate migraine disability (as measured
by a MIDAS ≥ 11). Patients that participated in the trial had an
average of more than five migraine attacks per month at baseline.
SAMURAI did not exclude patients with one or more cardiovascular
risk factors. The primary endpoint of the study was comparison of
the percentage of patients in the lasmiditan 200 mg and placebo
groups who were migraine pain-free at two hours following the first
dose. The key secondary endpoint of the study was comparison of the
percentage of patients in the lasmiditan 200 mg and placebo groups
who were free of their MBS (nausea, sensitivity to sound or
sensitivity to light) at two hours following the first dose.
About Migraine
Migraine is a disabling 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 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.
4,5
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 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 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. Data from SAMURAI, the first of two pivotal Phase 3
studies, was announced in 2016. 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 lasmiditan as a potential acute treatment for patients
with migraine, the SPARTAN, SAMURAI and GLADIATOR studies, 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
lasmitidan 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 undertakes no duty to update
forward-looking statements to reflect events after the date of this
release.
1 Headache disorders. World Health
Organization website.
http://www.who.int/mediacentre/factsheets/fs277/en/. Accessed
August 1, 2017.
2 Russo AF. Calcitonin gene-related
peptide (CGRP): a new target for migraine. Annual Review of
Pharmacology and Toxicology. 2015;55:533-552.
3 Identifying and treating migraine. American
Migraine Foundation website.
https://americanmigrainefoundation.org/understanding-migraine/identifying-treating-migraine/.
Last accessed August 2, 2017.
4 Migraine facts. Migraine Research
Foundation website.
http://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed August 2, 2017.
5 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.
Refer to:
Jen Dial;
dial_jennifer_kay@lilly.com; 317-220-1172 (Media)
Phil Johnson,
johnson_philip_l@lilly.com; 317-655-6874
(Investors)
View original
content:http://www.prnewswire.com/news-releases/lilly-announces-positive-results-for-second-phase-3-study-of-lasmiditan-for-the-acute-treatment-of-migraine-300499684.html
SOURCE Eli Lilly and Company