|Lilly CEO John Lechleiter|
Eli Lilly ($LLY) and Teva ($TEVA), racing with a pack of drugmakers with a new approach to treating migraines, said their respective injected therapies succeeded in midstage trials, setting the stage for pivotal studies.
Lilly's candidate, LY2951742, is an antibody to calcitonin gene-related peptide, or CGRP, which is a sensory chemical believed to play a role in the inflammation and pain signaling involved in migraines and cluster headaches. In a trial on more than 400 migraine sufferers, Lilly's medicine met its goal of charting a statistically significant improvement over placebo in the prevention of headaches, the company said. On the safety side, Lilly said its antibody charted a profile in line with earlier studies.
The drugmaker is disclosing only top-line results for now, saving full data for the weekend's American Headache Society meeting. Lilly has laid out plans for a pair of Phase III trials in cluster headaches set to begin this summer, plotting to test whether a monthly dose of LY2951742 can beat placebo in reducing the number of weekly episodes.
Teva, planning to present at the same conference, said its CGRP antibody met its goal of reducing the average number of migraines per month in a roughly 300-patient trial. TEV-48125, also a monthly treatment, led to about 6 fewer headaches per month at both tested doses, beating the 3.46 achieved with placebo. Now Teva is blueprinting a Phase III program of its own.
Elsewhere in CGRP, Amgen ($AMGN) and Alder Biopharmaceuticals ($ALDR) are pressing toward late-stage trials with similar antibodies. And, as Evercore ISI analyst Umer Raffat points out, Teva appears to be in the lead, at least on paper. Looking at the Phase II data thus far disclosed, TEV-48125 has notched the greatest average reduction in migraine days per month among CGRP contenders, Raffat said in a note to investors, but the company also recruited a study population with a higher number of baseline episodes than its rivals did, possibly accounting for the disparity.
Each company is plotting to kick off Phase III development this year, and the exact differences between the efficacy of the various antibodies likely won't be definite until those data are available.
- read Lilly's release
- here's Teva's statement