New Monoclonal Antibody Drugs for Migraine Prevention

Two new studies may offer hope for people with migraine. The two studies released today will be presented at the American Academy of Neurology’s 66th Annual Meeting in Philadelphia, April 26 to May 3, 2014.

Both studies involve drugs that are aimed at preventing migraine attacks from occurring, rather than stopping the attacks once they have started. These studies are the first to test monoclonal antibodies for the prevention of migraine, and both are directed against a relatively new target in migraine prevention, the calcitonin gene-related peptide, or CGRP. CGRP has been thought to be important in migraine, but never have drugs been developed to specifically target the protein.

Both are phase II studies, meaning larger studies are needed to confirm the results.

One study involved 163 people who had migraine from five to 14 days per month. They received either a placebo or a single IV dose of a drug called ALD403 and then were followed for 24 weeks. Those who received the drug had an average of 5.6 fewer migraine days per month, a 66-percent decrease, compared to 4.6 fewer days per month for those who received a placebo, or a 52-percent decrease. Sixteen percent of those who received the drug had no migraine days at 12 weeks, while none of those who received the placebo were free from migraine at that point.

There were no differences in side effects between those receiving the drug and those receiving the placebo.

“These results may potentially represent a new era in preventive therapy for migraine,” said Peter Goadsby, MD, PhD, of the UC San Francisco and a member of the American Academy of Neurology, who is an author on both studies.

“Migraine remains poorly treated, and there are few effective and well tolerated treatments approved that prevent attacks from occurring,” said David Dodick, MD, of Mayo Clinic Arizona in Phoenix and a member of the American Academy of Neurology, who was also an author on both studies. “There is a huge treatment need for migraine — the third most common and seventh most disabling medical disorder in the world.”

In the other study, 217 people who had migraine four to 14 days per month received biweekly subcutaneous injections of either a placebo or a drug called LY2951742 for 12 weeks.

Those who received the drug had an average of 4.2 fewer migraine days per month at 12 weeks, or a 63 percent decrease, while those who received placebo had 3 fewer migraine days per month, or a 42 percent decrease. Those who received the drug were more likely to have side effects including pain at the injection site, upper respiratory tract infections and abdominal pain, but overall the drug was considered to be safe and well-tolerated.

“We’re cautiously optimistic that a new era of mechanism-based migraine prevention is beginning,” Dodick said.

The ALD403 study was supported by Alder Biopharmaceuticals. The LY2951742 study was supported by Arteaus.

Source: The American Academy of Neurology (AAN)