Teva presents further data from Phase IIb trial of TEV-48125 in chronic migraine at IHC 2015

Teva will present further data from its chronic migraine Phase IIb study of TEV-48125 at the 17th Congress of the International Headache Society (IHC 2015) on Friday.

The Phase 2b study evaluates the efficacy and safety, versus placebo, of two doses of TEV-48125, an anti-calcitonin gene-related peptide (CGRP) ligand monoclonal antibody.

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 three.

A prior 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. This benefit increased progressively at one month. Similar decreases were seen for the number of moderate/severe headache days, where both doses separated from placebo at two weeks, and maintained at one month and three months.

Results provide a solid foundation to advancing the TEV-48125 programme into Phase III

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. Most common AEs were mild injection-site pain or pruritus.

“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, 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.”

“These results with TEV-48125 have not previously been achieved at any phase in chronic migraine. They are highly statistically significant, and provide a solid foundation to advancing the programme into Phase III,” said Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer. “Patients who have suffered from chronic migraine for many years now have a very good reason for hope.”