In a release issued under the same headline earlier today by
CoLucid Pharmaceuticals, Inc. (Nasdaq:CLCD), please note that
multiple changes have been made to the Adverse Events table. The
corrected release follows:
CoLucid Pharmaceuticals, Inc. (Nasdaq:CLCD), a biopharmaceutical
company that is developing lasmiditan oral tablets for the acute
treatment of migraine in adults, with or without aura, provided an
interim update on its Phase 3 long-term, open-label trial
evaluating lasmiditan, the GLADIATOR study. Migraine patients who
have completed CoLucid’s first Phase 3 pivotal trial, SAMURAI, as
well as CoLucid’s second Phase 3 pivotal trial, SPARTAN, are
eligible to enroll in GLADIATOR. GLADIATOR is expected to enroll up
to a total of 2,580 patients, who will be randomized to receive 100
mg or 200 mg of lasmiditan, and treat up to eight migraine attacks
per month for one year.
The primary endpoint of the GLADIATOR study is the proportion of
patients and the proportion of attacks associated with any adverse
event and with specific adverse events. The secondary endpoint is
the proportion of migraine attacks treated with lasmiditan 100 mg
and with lasmiditan 200 mg at the two-hour time point, calculated
for each three-month period within a 12-month period.
An interim update from GLADIATOR was presented by Dr. Uwe
Reuter, Department of Neurology and Director of the Headache
Center, Charité Universitätsmedizin Berlin, at a symposium during
the 5th European Headache and Migraine Trust International Congress
(EHMTIC 2016) that took place in Glasgow, Scotland on September 17,
2016. A copy of the presentation that was utilized at the
symposium is available on CoLucid’s website at:
http://www.colucid.com/wp-content/uploads/2016/09/CoLucid-EHMTIC-GLADIATOR-Presentation.pdf.
Enrollment and Retention
GLADIATOR has randomized 1,155 patients to date, or
approximately 45% of the anticipated 2,580 patients to be
randomized. Of patients randomized to date, the following table
provides a summary by each dose group and in total of the number of
randomized patients, the number of patients who remain active in
the study, the number of patients who have discontinued and the
retention rate. Overall, the retention rate in GLADIATOR to date
has been 74%.
Enrollment |
Lasmiditan 100mg |
Lasmiditan 200mg |
Total |
Randomized total |
|
558 |
|
|
597 |
|
|
1,155 |
|
Active |
|
395 |
|
|
456 |
|
|
851 |
|
Discontinued |
|
163 |
|
|
141 |
|
|
304 |
|
Retention Rate |
|
71 |
% |
|
76 |
% |
|
74 |
% |
Discontinuation from GLADIATOR was primarily driven by either
adverse events or by patient request. Patient request usually
indicated an unwillingness to participate in a 12-month study
requiring daily electronic diary engagement. Discontinuation was
fairly balanced between dose groups. The following table sets
forth, by dose group and in total, the number and percentage of
patients who have discontinued for which data is currently
available regarding the reason for discontinuation.
|
Lasmiditan100 mg |
Lasmiditan200 mg |
Total |
Discontinuations |
163 |
141 |
304 |
|
|
|
|
Data to date (213 of 304 discontinuations), n (%) |
113 (53%) |
100 (47%) |
213 (100%) |
Adverse Events |
40 (19%) |
43 (20%) |
83 (39%) |
Patient request |
54 (25%) |
29 (14%) |
83 (39%) |
Lost to follow-up |
8 (4%) |
8 (4%) |
16 (8%) |
Non-compliance with protocol |
7 (3%) |
8 (4%) |
15 (7%) |
Sponsor request |
2 (1%) |
5 (2%) |
7 (3%) |
Investigator request |
2 (1%) |
4 (2%) |
6 (3%) |
Pregnancy |
0 |
3 (1%) |
3 (1%) |
To date, 7,589 total doses of lasmiditan have been administered
in GLADIATOR. First dose administration was relatively balanced
between the 100 mg and 200 mg dose groups (2,849 and 2,614,
respectively). Second dose utilization was 44% (1,257) for the 100
mg dose group and 33% (869) for the 200 mg dose group. The second
dose utilization in GLADIATOR has been similar to that in SAMURAI,
44% vs. 46%, respectively, for the 100 mg dose group, and 33% vs.
39%, respectively, for the 200 mg dose group. The following
table sets forth dosage data from GLADIATOR.
Patients dosed in each arm (n=) |
Lasmiditan 100
mg(n=473) |
Lasmiditan 200
mg(n=465) |
Total(n=938) |
Count of first dose taken |
|
2,849 |
|
|
2,614 |
|
|
5,463 |
|
Count of second dose taken |
|
1,257 |
|
|
869 |
|
|
2,126 |
|
% of patients taking 2nd dose |
|
44 |
% |
|
33 |
% |
|
39 |
% |
|
|
|
|
Total number of doses taken |
|
4,106 |
|
|
3,483 |
|
|
7,589 |
|
Adverse Events
Patients have been treated for multiple migraines with
lasmiditan in GLADIATOR. Lasmiditan has been well tolerated in
GLADIATOR, with the majority of treatment emergent adverse events
(TEAE) being nervous system related. Importantly, there has not
been a significant increase in cardiovascular adverse events in
patients randomized in GLADIATOR. The following table sets forth
the number of patients who experienced the specified TEAE within
the safety population following a dose of study drug, followed by
the total number of adverse events experienced by TEAE.
TEAE, n (events) |
Lasmiditan 100mg(n=558) |
Lasmiditan 200mg(n=597) |
All Patients(n=1,155) |
Dizziness |
36 (48) |
40 (67) |
76 (115) |
Lethargy/Heaviness |
7 (15) |
1 (2) |
8 (17) |
Numbness |
2 (2) |
8 (12) |
10 (14) |
Sleepiness/Somnolence |
15 (21) |
18 (39) |
33 (60) |
Tingling |
14 (16) |
10 (17) |
24 (33) |
Vertigo |
4 (4) |
5 (7) |
9 (11) |
Weakness |
7 (11) |
11 (24) |
18 (35) |
“Interim GLADIATOR data demonstrate that lasmiditan is well
tolerated and the retention rate looks very good for such a
comprehensive long term study,” said Dr. Reuter. “The expansive use
of e-diaries for real time data collection in GLADIATOR has been
scientifically innovative for the migraine community.”
About LasmiditanLasmiditan has been designed
for the acute treatment of migraine headaches in adults without the
vasoconstrictor activity associated with previous generations of
migraine therapies. It selectively targets 5-HT1F receptors
expressed in the trigeminal pathway. Lasmiditan has been
given the generic stem name “ditan,” which distinguishes it from
other drug classes, including triptans, the current standard of
care for migraine.
CoLucid has completed its first pivotal Phase 3 clinical trial
of lasmiditan oral tablets, SAMURAI, which was a randomized,
double-blind, placebo-controlled parallel group study designed to
evaluate the efficacy and safety of lasmiditan (100 mg and 200 mg)
in comparison to placebo. Both 100 mg and 200 mg doses of
lasmiditan were efficacious on headache pain freedom, the primary
endpoint, and most bothersome symptom freedom, the key secondary
endpoint, at the two-hour time point (p < 0.001). Both 100 mg
and 200 mg doses of lasmiditan were also efficacious on headache
pain relief at the two-hour time point (p < 0.001), efficacious
as a rescue medication on headache pain freedom at the two-hour
time point (p < 0.001 and p < 0.012), and effective in
reducing migraine related disability at the two-hour time point (p
< 0.001) and improving Patient Global Impression of Change (p
< 0.001). Lasmiditan was well tolerated with no significant
difference in cardiovascular adverse events in patients dosed with
lasmiditan versus placebo. SAMURAI is the first of two Phase 3
pivotal trials of lasmiditan, each being conducted under a Special
Protocol Assessment agreement (“SPA”) with the U.S. Food and Drug
Administration (“FDA”).
CoLucid is currently enrolling patients in a second pivotal
Phase 3 clinical trial of lasmiditan oral tablets, SPARTAN. The
objective of SPARTAN is to evaluate the safety and efficacy of
lasmiditan (50 mg, 100 mg and 200 mg) in comparison to placebo two
hours after dosing on freedom from migraine headache pain, which is
the primary endpoint, and on freedom from the most bothersome
associated symptom of migraine (nausea, phonophobia or
photophobia), which is the key secondary endpoint. SPARTAN is a
randomized, double-blind, placebo-controlled parallel group
study. The study is expected to treat a single migraine in up
to 2,226 migraine patients with lasmiditan at approximately 140
sites in the United States, United Kingdom and Germany.
CoLucid expects that migraine patients enrolled in SPARTAN will
include those who also have one or more cardiovascular risk
factors, stable cardiovascular disease or known coronary artery
disease (“CAD”). CoLucid has obtained an SPA agreement from the FDA
for SPARTAN. Top-line results from SPARTAN are expected in the
second half of 2017.
CoLucid is also currently enrolling patients in GLADIATOR, a
Phase 3 long-term, open-label trial of lasmiditan. GLADIATOR’s
objective is to evaluate the safety and efficacy of lasmiditan, as
well as resource utilization, functional outcomes and disability.
Based on the results of GLADIATOR, CoLucid intends to build an
appropriate safety database to support a New Drug Application
(“NDA”) for lasmiditan. At the time of the NDA submission, it is
anticipated that there will be more than 15,000 patient exposures
to lasmiditan in the entire clinical program.
About MigraineMigraine is the leading cause of
disability among neurological disorders in the United States
according to the American Migraine Foundation. An estimated
36 million Americans suffer from migraine. Migraine can be
extremely disabling and costly, accounting for more than an
estimated $20 billion in direct (e.g., doctor visits, medications)
and indirect (e.g., missed work, lost productivity) expenses each
year in the United States.
About CoLucid Pharmaceuticals, Inc.CoLucid was
founded in 2005 and is developing lasmiditan oral tablets for the
acute treatment of migraine headaches in adults and intravenous
lasmiditan for the acute treatment of headache pain associated with
migraine in adults in emergency room and other urgent care
settings.
Forward-Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to CoLucid’s
expectations for lasmiditan’s efficacy, anticipated marked demand,
anticipated physician prescribing patterns, clinical trial
enrollment goals and the timing of future clinical trials. Actual
enrollment results, market demand, use of cash and other
developments may occur that differ materially from those projected
or implied in these forward-looking statements. Factors that may
cause such a difference include risks that enrollment goals will
not be met, trials may not be commenced or successful or may take
longer to complete than anticipated, regulatory approval may not be
obtained, physicians may not prescribe lasmiditan, and projected
cash needs and expected financial results may be different. More
information about the risks and uncertainties faced by CoLucid are
contained in its periodic reports filed with the Securities and
Exchange Commission. CoLucid disclaims any intention or obligation
to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
CONTACT
Thomas Mathers
Chief Executive Officer
CoLucid Pharmaceuticals, Inc.
(857) 285-6494
Hans Vitzthum
Managing Director
LifeSci Advisors, LLC.
(212) 915-2568
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