CoLucid Pharma Reports Confirmatory Support for Non-Vasoconstrictive Mechanism of ACtion for Lasmiditan

CoLucid Pharmaceuticals, Inc. CLCD, a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches, announced today the completion of a preclinical in vivo study examining the effect of lasmiditan on coronary and carotid artery diameters. This study confirms the lack of effect of lasmiditan on coronary artery and carotid artery vasoconstriction; the data are expected to be used in support of potential future regulatory filings. In this study conducted by CorDynamics in Chicago, IL, lasmiditan was directly compared to sumatriptan, the most widely prescribed acute treatment for migraine. Lasmiditan, sumatriptan and vehicle control were administered by intravenous infusion in escalating cumulative doses ranging from 0.03 to 11.13 mg/kg. Significant decreases in both carotid and coronary diameters were observed in sumatriptan-treated animals even at 0.03 mg/kg, which is calculated to be the equivalent to the lowest approved oral clinical dose of 25 mg. Conversely, lasmiditan did not induce any significant decrease in arterial diameters at any dose tested. Lasmiditan plasma concentrations reached above 3,500 ng/mL following a cumulative dose of 11.13 mg/kg, which is significantly above the highest exposure achieved in clinical settings. "Lasmiditan is highly selective for the serotonin receptor 5-HT1F," stated Dr. Joseph Kovalchin, Director of Research. "Triptans are thought to treat migraines by inducing vasoconstriction through other serotonin receptors (5-HT1B/1D) on cranial blood vessels; however, triptans also induce unwanted vasoconstriction of the coronary and carotid arteries. The lack of vasoconstrictive effect of lasmiditan in this model reinforces the fact that targeting 5-HT1F does not trigger the same undesirable effects." Data from this study, which has been conducted in accordance with Good Laboratory Practice (GLP), as well as from other experimental investigations, will be submitted for publication in a peer-reviewed journal, and presented at an upcoming international conference. "These new data confirm and expand on our hypothesis that lasmiditan may be a more appropriate choice to treat migraine patients who have cardiovascular risk factors and coronary artery disease," stated Thomas P. Mathers, Chief Executive Officer. "The Food and Drug Administration has asked us to confirm lasmiditan's lack of vasoconstrictive effect on coronary arteries to support potential labeling discussions in migraine patients with cardiovascular comorbidities. We are very pleased with the data from this preclinical GLP study."