Clinical Data

Clinical work to date includes 5 clinical studies in 123 healthy subjects and 393 migraine patients dosed with the active drug. We believe the data shows and supports the following conclusions:

Formulation Phase Study Objectives # of Subjects / Exposures
IV Infusion 1 Safety, Tolerability & PK 39 / 78
Oral Solution and Sublingual 1 Safety, Tolerability & PK 60 / 88 Download
Oral Solution and Tablet 1 Bioavailability and Pharmacokinetics of Tablet 44 / 57 Download
IV Infusion 2 Efficacy and safety of a range of intravenous doses 130 / 88 Download
Tablet 2b Efficacy and safety of a range of oral doses 534 / 390 Download

Conclusions

  • Proof of Efficacy by the Oral Route
  • Differentiated profile for both Safety and Efficacy
  • 100 mg an attractive dose for further development
  • Lasmiditan ready to advance to Ph3 trials

Oral Phase 2b Trial

The most recent trial, an oral Phase 2b trial, was a multicenter, placebo-controlled, parallel-group, dose ranging study conducted in 43 centers in Europe. Over 500 patients were randomized with 391 treating an attack with study medication.

Reduction of a moderate or severe headache at baseline to mild or none 2 hours after dosing

Headache Response: Reduction of a moderate or severe headache at baseline to mild or none 2 hours after dosing
* p < 0.05 vs PBO

Key Results in Phase 2b

Efficacy

  • Primary end point was met—Dose response for 2 hour headache relief was highly significant (p<0.0001)
  • Significant differences of individual dose levels from placebo, from 30 minutes on
  • Pain free dose response at 2 hours highly significant (p<0.0006)
  • All 5 of major endpoints likely to be required by FDA achieved or approached statistical significance.

Note: Study powered for primary endpoint, not to show significance for all endpoints

Safety

  • No evidence of drug-related cardiovascular effects
  • Chest symptoms uncommon and frequency similar to placebo
  • Most frequent AEs nervous system related
  • No clinically significant drug related effects on: Vital signs, hematology, clinical chemistry or ECG's

Publications