Fremanezumab Phase III Migraine Trial

Fremanezumab is a drug being developed by Teva Pharmaceuticals for the prevention of migraine. Fremanezumab is a monocolonal antibody and a biological agent that binds to and blocks the action of a migraine-associated protein called calcitonin gene-related peptide (CGRP).  Results of the phase III clinical trial were published in Nov., 2017, in the New England Journal of Medicine. This study showed that fremanezumab was found successful in reducing the number of days that chronic migraine sufferers experienced headaches.

It is estimated that between 127 and 300 million people in the entire world experience chronic migraine, with 15 or more headaches per month for at least three months. Those who experience such intense and chronic migraines have a tough time finding effective relief. As such fremanezumab has been developed to hopefully help those who suffer and do not have any current medication that is effective. CGRP is released at high levels during migraine in response to inflammation, and triggers a cascade effect that leads to even more CGRP release. This causes increased sensitivity of the brain to pain. By blocking CGRP, as fremanezumab has been developed to do, the cycle of increasing inflammation and increased pain sensitivity that leads to migraine headaches may potentially be stopped.

Researchers from 132 sites across nine countries enrolled 1,130 patients and randomly assigned them to one of three groups: one that received placebo injections, one that received quarterly treatments, and a group that received one treatment per month. The trial lasted for 16 weeks and had a 12-week treatment window. The trial showed that treatment with fremanezumab reduced the number of days patients experience headache by an average of 4.3 days for those with quarterly treatment and 4.6 days for those with monthly treatment. In addition, some patients had 100% reduction in migraine and others with a bit less percentage.

The researchers found the percent of patients who had more than a 50% reduction in the number of days they experienced either a severe or moderate headache per month. The researchers saw that 37.6% of patients on the monthly treatment regimen, and 40.8% on the quarterly treatment regimen had at least a 50% reduction in the number of moderate headaches per month. Note that 18.1% of patients in the the placebo group also had at least a 50% reduction in the number of moderate headaches per month. The treatment had a favorable safety record with the most common adverse complication occurring as irritation at the injection site. The researchers feel that this treatment with fremanezumab, if approved by the FDA, will give doctors a new medication to prescribe to patients to reduce the amount of headaches they suffer and help them lead more normal lives.

The stock price of Teva Pharmaceuticals faced heavy selling pressure in 2017. If fremanezumab is approved by the FDA in 2018, it may help benefit both shareholders and migraine sufferers alike. Also see the post where developing drugs to target CGRP was discussed.

Source: Stephen D. Silberstein and et al., Fremanezumab for the Preventive Treatment of Chronic Migraine. New England Journal of Medicine, vol. 377, issue 22, 2017.

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