The FINANCIAL — Teva Pharmaceutical Industries Ltd. announced the presentation of further 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 (IHC 2015), according to Teva.
Both assessed doses of TEV-48125 (loading of 675 followed by monthly injections of 225 mg or 900 mg), were significantly superior to placebo in reducing, relative to baseline, the number of hours with headache (primary endpoint – p < 0.05 and p < 0.01). TEV-48125 also significantly decreased the number of headache days of moderate or severe intensity in month 3 (secondary endpoint – p < 0.05 and p < 0.05).
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: decrease of headache hours from baseline (primary endpoint) at week 1 was -9.1 for TEV-48125 675/225mg (p = 0.03), -11.4 for 900 mg (p = 0.003), and -2.8 for placebo. This benefit increased progressively at 1 month, with decreases of -44.1 hours for 675/225 mg (p = 0.003), -56.82 hours for 900 mg (p < 0.001) and -18.1 hours for placebo. At three months decreases were -59.8 for 675/225 mg (p = 0.04) -67.5 for 900 mg (p = 0.006) and -37.1 for placebo. Similar decreases were seen for number of moderate/severe headache days (secondary endpoint), where both doses separated from placebo at 2 weeks, and maintained at 1 month and 3 months.
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. No other relevant differences in the rate of treatment-emergent adverse events occurred for those receiving TEV-48125 doses relative to placebo. Antibodies anti-drug were the lowest in class up to this point (1.1% for TEV-48125 in this trial, and present before drug exposure).
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.
The study was conducted amongst 264 highly severe chronic migraine patients who suffered from a mean of approximately 162 headache hours per month (approx. 17 migraine days per month, and around 21 days of headache per month). They had suffered from migraines for mean period of 18 years. Amongst the most affected of these patients (upper third), 42% reverted to episodic migraine in the 675/225 mg arm and 43% in the 900 mg arm, vs 22% in placebo. Overall, by the end of the study nearly 60% of patients reverted from chronic to episodic migraine.
“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.”
“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 program 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.”
