Lilly (LLY) Says Two New Analyses of Lasmiditan Phase 3 Studies Measured Onset of Effect and Effect of Lasmiditan in Patients with Prior Triptan Experience

May 8, 2019 6:54 AM EDT

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Eli Lilly and Company (NYSE: LLY) today announced new data and post-hoc analyses for lasmiditan, an investigational, oral, first-in-class molecule for the acute treatment of migraine, being presented at the Annual Meeting of the American Academy of Neurology (AAN) taking place in Philadelphia from May 4-10, 2019. The presentations include pooled analyses from the Phase 3 SAMURAI and SPARTAN studies. The first analysis, presented on Monday, May 6, reviewed data on the early onset of effect of lasmiditan for several key outcomes. The second analysis, being presented today, shared data on the effect of lasmiditan in patients who took a triptan within the three months prior to study participation. In addition to these new analyses, Lilly presented interim results from the Phase 3, one-year, open-label extension study of lasmiditan (GLADIATOR), on Sunday, May 5, that showed results on measures of safety and efficacy were generally consistent with observations from the SAMURAI and SPARTAN studies.

Lasmiditan is a centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct from other approved migraine therapies and lacks vasoconstrictive activity. It is the first and only molecule in the "ditan" class under evaluation by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults.

"Migraine remains one of the most debilitating neurologic diseases, impacting more than 30 million adults in the U.S. The ability to quickly stop migraine attacks continues to be an important objective in advancing the acute treatment of this serious disorder. These new analyses showed that lasmiditan may provide rapid relief from a migraine attack and may be an effective option for people who have tried triptans. The data presented from the lasmiditan Phase 3 program included more than 4,000 patients and treatment of over 20,000 migraine attacks. This research represents Lilly's commitment to helping people across the spectrum of the disease," said Gudarz Davar, M.D., vice president, Neurology Development, Lilly Bio-Medicines.

Onset of Efficacy Findings from the Phase 3 SAMURAI and SPARTAN StudiesA pooled analysis of these Phase 3 studies was conducted to determine the onset of improvement in migraine symptoms after taking lasmiditan (50 mg, 100 mg or 200 mg) versus placebo. Rates of pain relief, and freedom from most bothersome symptom (MBS; patient selected from nausea, photophobia which is sensitivity to light, or phonophobia, which is sensitivity to sound) were both higher and statistically significant starting as early as 30 minutes post-dose in the lasmiditan 100 mg and 200 mg treated groups (p<0.05) when compared with placebo. The 200 mg lasmiditan treated group also achieved higher and statistically significant rates of freedom from photophobia and phonophobia than placebo starting as early as 30 minutes post-dose (p<0.05).1 The primary endpoint of freedom from pain was statistically significant for both the 100 mg and 200 mg doses starting at 60 minutes (p<0.05 and p<0.001, respectively).1

These results were presented on Monday, May 6, in an oral presentation (S17.007) from 1:00 PM – 3:00 PM.

Response to Lasmiditan Based on Prior Experience with Triptan Therapy from the Phase 3 SAMURAI and SPARTAN StudiesTo assess the effect of prior triptan exposure on lasmiditan efficacy, a post-hoc analysis of the pooled Phase 3 studies was conducted on patients who reported taking triptans within three months of trial enrollment. At baseline, patients rated themselves as either having a good, poor, or no response to triptans within the three months prior to study participation. The results showed that patients taking lasmiditan experienced higher rates of freedom from pain, freedom from MBS and pain relief versus placebo, regardless of prior experience with triptans.2

The data is being presented in a poster presentation (P4.10-022) from 11:30 AM – 6:30 PM today.

Long-Term Safety and Efficacy of Lasmiditan Over One Year: GLADIATOR Interim ResultsInterim results were also shared from the Phase 3, prospective, randomized, open-label GLADIATOR study which enrolled patients who had previously participated in the single-attack SAMURAI and SPARTAN studies. Patients were randomized 1:1 to receive lasmiditan 100 mg or 200 mg over 12 months, with a median duration of time in study of 288 days for these interim results. At the time of interim analysis, 1,978 patients had received at least one dose of lasmiditan and 19,058 acute migraine attacks had been treated.3

The most frequent treatment-emergent adverse events (TEAEs) (>2%) were dizziness (18.6%), somnolence (sleepiness or drowsiness; 8.5%), paresthesia (tingling or numb sensation on the skin; 6.8%), fatigue (5.5%), nausea (4.7%) and asthenia (physical weakness or lack of energy; 2.0%). The incidence and types of TEAEs were similar to those in the SAMURAI and SPARTAN studies.3

The lasmiditan efficacy results from this interim analysis, defined as achieving freedom from pain and freedom from MBS, also appeared similar to the results from the SAMURAI and SPARTAN studies and were consistent across sequential three-month quarters of the study.3

These data were presented in a poster presentation (P1.10-021) on Sunday, May 5 from 11:30 AM – 6:30 PM.

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