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Teva’s Phase IIb chronic migraine trial of TEV-48125 meets primary and secondary endpoints

Israel-based Teva Pharmaceutical Industries has reported positive results from a Phase IIb trial of two doses of subcutaneous TEV-48125, an investigational anti-calcitonin gene-related peptide (CGRP) monoclonal antibody for the prevention of chronic migraine.

The trial evaluated the efficacy, safety, tolerability as well as compared two active arms of different doses of TEV-48125, administered as a subcutaneous injection, once a month for three months, against placebo.

The results showed that both tested doses of TEV-48125 achieved the trial’s primary and secondary efficacy endpoints one and three months.

Teva head of Global Clinical Development for Migraine and Headaches Marcelo 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 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."

After a 28 day run-in period in trial, 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.

A total of 261 patients were included in the multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group, multi-dose trial, of which 172 received TEV-48125.

The company said that full results from the trial will be presented at a forthcoming meeting and will be submitted to a peer-reviewed journal for publication.