INDIANAPOLIS, Sept. 9, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) will present key primary and secondary endpoint
data for lasmiditan, an investigational, oral,
first-in-class molecule for the acute treatment of migraine, which
demonstrated statistically significant improvements compared to
placebo in the Phase 3 SPARTAN study. Detailed results will be
highlighted today at the 18th Congress of the International
Headache Society (IHC) in Vancouver.
"The data presented today demonstrate lasmiditan's potential to
reduce pain and provide freedom from the most bothersome symptoms
associated with migraine," said Christi
Shaw, president of Lilly Bio-Medicines. "These results
reflect Lilly's 25-year commitment to migraine research and to
bringing first-in-class advancements to patients, including the use
of a new clinical endpoint evaluating a patient's self-identified
most bothersome symptom."
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. The most commonly-reported adverse
events after lasmiditan dosing were dizziness, paresthesia,
somnolence, fatigue, nausea and lethargy.
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, 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). A statistically
significantly greater percentage of patients were also free of
their most bothersome symptom (MBS) compared with placebo at two
hours. In this study, patients chose their MBS from nausea,
sensitivity to sound or sensitivity to light.
The majority of patients treated with lasmiditan also
experienced relief from migraine pain—classified as mild or no
pain—at two hours following the first dose (59 percent for 50 mg,
64.8 percent for 100 mg and 65 percent for 200 mg, p<0.001 for
all dosing groups). These results were statistically significant
compared to placebo (47.7 percent).
In this study, fewer patients treated with lasmiditan took a
second, rescue dose of treatment compared to placebo (41 percent
for 50 mg; 32.7 percent for 100 mg; 26.4 percent for 200 mg and
49.8 percent for placebo).
Lilly will submit the results to a peer-reviewed journal 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. A key secondary endpoint of the
study was comparison of the percentage of patients in each dosing
group (200 mg, 100 mg and 50 mg) and placebo groups who were free
of their MBS at two hours following the first dose. In these
studies, MBS identified by patients included nausea, sensitivity to
sound or sensitivity to light.
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.3,4 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
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, including those 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 lasmiditan as a potential acute treatment for patients
with migraine and the SPARTAN trial, 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 lasmiditan 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
September 7, 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 September 7, 2017.
4 Migraine facts. Migraine Research
Foundation website.
http://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed September 7, 2017.
Refer to: Jen Dial;
dial_jennifer_kay@lilly.com; 317-220-1172 (Lilly
Bio-Medicines)
Phil Johnson;
johnson_philip_l@lilly.com; 317-655-6874 (Investor
Relations)
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SOURCE Eli Lilly and Company