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Clinical Trials

Date: 2015-06-17

Type of information: Presentation of results at a congress

phase: 2b

Announcement: presentation of results at the 57th Annual American Headache Society meeting on June 20 in Washington D.C.

Company: Eli Lilly (USA - IN)

Product: LY2951742

Action mechanism:

monoclonal antibody. LY2951742 is a once-monthly subcutaneously injected calcitonin gene-related peptide (CGRP) antibody currently being studied as a potential treatment for the prevention of chronic and episodic migraine and cluster headache. Lilly\'s CGRP antibody is a biologic entity that binds and inhibits the activity of CGRP, a sensory neuropeptide thought to be associated with vasodilation, pro-inflammatory effects and pain signaling, all thought to be implicated in the pathophysiology of migraine and cluster headache.

Disease:

prevention of migraine headache

Therapeutic area: CNS diseases

Country:

Trial details:

Latest news:

* On June 17, 2015, Eli Lilly announced that its investigational medicine for prevention of migraine (LY2951742, a CGRP neutralizing antibody) met the primary endpoint in a Phase 2b study in episodic migraine. The randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of four different doses of LY2951742 given in a once-monthly, subcutaneous injection in more than 400 patients with episodic migraine (people who experience between four and 14 migraine headache days per month). The primary objective was to assess whether at least one dose of LY2951742 was superior to placebo in the prevention of migraine headache. LY2951742 demonstrated a statistically significant reduction in migraine headache days and a safety and tolerability profile confirming the previous results seen in a Phase 2a study. Lilly will present data from this trial in a late-breaking session at the 57th Annual American Headache Society meeting on June 20 in Washington D.C., and will submit data from the study for additional disclosure at scientific meetings and in peer-reviewed journals.

In addition to the migraine program, Lilly has initiated two Phase 3 trials with LY2951742 in patients suffering from cluster headache. Based on the unmet medical need and significance of this disorder for patients, Lilly has been granted Fast Track Designation from the FDA for cluster headache.

Is general: Yes