November 30, 2017

Jefferson clinical trial shows promise for new migraine therapy

Jefferson clinical trial shows promise for new therapy

Pharmaceuticals Migraines
Stock_Carroll - Thomas Jefferson Hospital Thom Carroll/PhillyVoice

An entrance to a Thomas Jefferson University Hospital building on South 10th Street.

Researchers at Thomas Jefferson University Hospital may be nearing a breakthrough in the treatment of chronic migraines, a debilitating condition the World Health Organization estimates affects between 127 and 300 million people around the world.

Results from a phase III clinical trial of fremanezumab, an antibody therapy that counteracts a key inflammatory molecule in migraines, found a dramatic reduction in the number of days participating patients suffered from headaches.

The immunotherapy, developed by Teva Pharmaceuticals, binds the biological agent fremanezumab to a migraine-associated protein called calcitonin gene-related peptide (CGRP) and blocks the cascade effect of its release in response to inflammation.

CGRP has become a focal point of research and drug development because migraine specialists believe the peptide is responsible for the brain's increased sensitivity to pain during periods of inflammation.

“This therapeutic approach offers new hope for people whose migraines cannot be treated with existing medicine,” said Stephen D. Silberstein, professor of neurology and director of the Jefferson Headache Center.

The 16-week HALO CM trial, a collaborative study spanning 132 sites across nine countries, enrolled 1,130 patients and randomly assigned them to one of three groups. Group one received quarterly treatments, group two received monthly treatment and group three received placebo injections.

Study results published Wednesday in the New England Journal of Medicine show that fremanezumab reduced the number of days patients experience headache by an average of 4.3 days with quarterly treatment and 4.6 days with monthly treatment.

“We saw some patients with 100 percent reduction in migraine, others with 75 percent reduction,” said Silberstein, who served as the trial's principal investigator.

Another aspect of the study examined the therapy's effectiveness relative to each patient's headache burden, noting that responses varied between patients.

Among all patients who had more than a 50 percent reduction in the number of days they experienced either a severe or moderate headache per month, 37.6 percent on the monthly treatment regimen and 40.8 percent on the quarterly treatment regimen had at least a 50 percent reduction in the number of moderate headaches they experienced per month. Only 18.1 percent of the placebo group, by comparison, had 50 percent reduction in moderate headaches per month.

Silberstein noted that the therapy had a favorable safety profile. The most common adverse event reported, in all three groups, was irritation at the injection site.

Teva Pharmaceuticals will now look to gain FDA approval for the therapy.

“If approved, this treatment would provide physicians with an important new tool to help prevent migraine, reduce a patient’s migraine load, and potentially help patients return to normal," said Silberstein.