Positive Phase 3 Results for Fremanezumab in Migraine

Pauline Anderson

June 02, 2017

Patients treated with fremanezumab (Teva Pharmaceutical Industries), an investigational agent for the prevention of chronic migraine, experienced a statistically significant reduction in headache days compared with placebo, topline results released by the company show.

Fremanezumab is a fully humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP). CGRP signaling may be disrupted by targeting the ligand itself or its receptor.

The phase 3 HALO study in chronic migraine was a 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study that compared the safety, tolerability, and efficacy of subcutaneous fremanezumab with placebo in adults.

The 1130 study participants were randomly assigned to receive subcutaneous injections of fremanezumab at a dose of 675 mg at initiation followed by monthly 225 mg for 2 months (monthly dose regimen), fremanezumab at 675 mg at initiation followed by placebo for 2 months (quarterly dose regimen), or three monthly doses of matching placebo.

Following a screening visit and a 28-day run-in period, there was a 12-week treatment period, with a final evaluation 4 weeks after the final dose of study drug.

The study met its primary endpoint, showing that patients taking the drug experienced a statistically significant reduction in the number of monthly headache days of at least moderate severity compared with placebo (–2.5 days) during the 12-week period after the first dose, for both monthly (–4.6 days; P < .0001) and quarterly (–4.3 days; P < .0001) dosing regimens.

Patients treated with fremanezumab also experienced significant improvement compared with placebo on all secondary endpoints for both monthly and quarterly dosing regimens. These included response rate, onset of efficacy, efficacy as monotherapy, and disability.

The most commonly reported adverse event in the study was injection site pain, with similar rates in the placebo and active groups.

On the basis of these results, Teva plans to submit a Biologics License Application to the US Food and Drug Administration for fremanezumab later this year.

Fremanezumab is among a number of agents that block CGRP, a vasodilator, and are being developed for the prevention of migraine.

Treatment with CGRP antibody erenumab (AMG 334, Amgen and Novartis) was shown in the phase 3 STRIVE and ARISE trials (reported at the recent American Academy of Neurology annual meeting) to reduce the frequency of episodic migraine — without the side effect profile commonly found with other migraine medications.

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