Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today announced positive results from a Phase IIb study evaluating the efficacy, safety and tolerability of two doses of subcutaneous TEV-48125, an investigational anti-calcitonin gene-related peptide (CGRP) monoclonal antibody for the prevention of chronic migraine (migraine with headaches on at least 15 days per month).
The study compared two active arms of different doses of TEV-48125, administered as a subcutaneous injection, once a month for three months, against placebo. Results demonstrated that both tested doses of TEV-48125 achieved the primary and secondary efficacy endpoints of the study at one and three months. The data revealed a significant and clinically relevant reduction in both the number of monthly cumulative headache hours, and the number of headache days of at least moderate severity, relative to baseline.
In this study, Teva added, no important safety or tolerability concerns were identified. The adverse event profile for TEV-48125 appeared similar to placebo and supportive of previous Phase I safety data. Of the adverse events reported, mild, transient injection site discomfort and redness was infrequent but higher than that observed in the placebo group. No serious treatment-related adverse events were seen.
Teva’s head of Global Clinical Development for Migraine and Headaches Marcelo E. Bigal said, “For the first time in chronic migraine, there is clinical data on the positive role of calcitonin gene-related peptide signaling disruption using a monoclonal antibody."
Teva’s president of Global R&D and chief scientific officer Michael Hayden said, “Chronic migraine is a challenging, complex and highly debilitating condition that desperately needs effective new treatment options. These results in support of TEV-48125 take us a step closer to realizing the potential of the anti-CGRP ligand-based approach for millions of women and men who suffer from chronic migraine.”
Published by Globes [online], Israel business news - www.globes-online.com - on February 24, 2015
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