CoLucid Pharmaceuticals (CLCD) Offers Interim Update on Lasmiditan Phase 3
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CoLucid Pharmaceuticals, Inc.(Nasdaq: CLCD) 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 which 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|
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|
|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|
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)|
|Paresthesia||7 (15)||1 (2)||8 (17)|
|Somnolence||2 (2)||8 (12)||10 (14)|
|Nausea||15 (21)||18 (39)||33 (60)|
|Fatigue||14 (16)||10 (17)||24 (33)|
|Lethargy||4 (4)||5 (7)||9 (11)|
|Vertigo||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.”
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