New study shows promising results

Teva Announces Positive Results for TEV-48125 in Phase IIb Chronic Migraine Study

 

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) (“Teva”) has 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 was a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group, multi-dose study comparing TEV-48125 with placebo. Following a 28 day run-in period, qualifying patients were randomized to one of three treatment arms receiving high dose TEV-48125, low dose TEV-48125 or placebo, given subcutaneously once a month for three months. 261 patients were included in the trial, 172 receiving TEV-48125. 


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.


“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” said Marcelo E. Bigal, Teva’s Head of Global Clinical Development for Migraine and Headaches.

 

Migraine Action are thrilled at the progress being made by Teva and will continue to keep you updated on any new developments. For further information please click here > 


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