Teva Pharmaceutical Industries was higher in pre-bell trade Thursday after the drug company outlined data from its chronic migraine phase 2b study evaluating the efficacy and safety, versus placebo, of two doses of TEV-48125, an anti-calcitonin gene-related peptide (CGRP) ligand monoclonal antibody.
These data will be presented on Friday, May 15th, 2015, as a late breaking oral presentation at the 17th Congress of the International Headache Society.
Both assessed doses of TEV-48125 were significantly superior to placebo in reducing, relative to baseline, the number of hours with headache. TEV-48125 also significantly decreased the number of headache days of moderate or severe intensity in month 3.
A priori analyses indicated that separation from placebo was seen after a single dose of therapy, and exploratory analyses also showed both doses of TEV-48125 separating from placebo as early as one week post-treatment.
Additionally, TEV-48125 was associated with a significant decrease in the consumption of acute migraine medications. No treatment-related serious adverse events were reported with use of TEV-48125.
Furthermore, over half of the patients in both dose groups experienced a 50% or more decrease in headache frequency (p<0.01 for both doses vs. placebo), nearly one third of patients in both dose groups had a 75% decrease in headache frequency (p < 0.05 for both doses) and around 15% were totally free of headaches at month three.
“Chronic migraine represents an incredibly debilitating neurological disorder which significantly diminishes quality of life and disables the sufferers,” said Alan M. Rapoport, M.D. President of the International Headache Society, as well as Clinical Professor of Neurology at The David Geffen School of Medicine at UCLA, Los Angeles, and a co-author of the study. “Although all individuals with chronic migraine qualify for preventive therapy, most do not receive it and a substantial proportion of those who receive it, end up discontinuing therapy. These data provide a basis for real hope for chronic migraine patients. The speed and magnitude of reductions in migraine hours and days seen in this trial may significantly, and positively, impact the lives of these patients.”