A new phase 2 trial of ALD403, a humanized monoclonal antibody directed against calcitonin gene-related peptide (CGRO) showed that the drug was safe and effective.
Although preliminary, the results are promising, said lead author, David W. Dodick, professor, neurology, Mayo Clinic, Phoenix, Arizona.
“In 30 years of preclinical work in animals, and clinical work in humans, this is the most validated target in migraine,” he said.
Effective and fast preventive treatments for migraine, which is the third most prevalent and seventh most disabling disease in the world, are lacking, said Dr. Dodick.
“If you spent a day in my clinic, this would become obvious. There is an absolutely desperate need for preventative medications which dramatically reduce, if not eliminate, migraine attacks. The drugs we have now are fraught with side effects and they work in 50% or less of patients.”
This drug is designed specifically to prevent migraine.
In contrast, triptans are used in the acute treatment of migraine. Dr. Dodick said triptans have a number of drawbacks. Four of 5 patients taking triptans “don’t get the pain-free response that we’d like to see” in an acute medication.
Results of the study showed that adverse events linked with the drug were transient and mild to moderate in severity. The study also suggests that the drug significantly reduced the mean number of migraine headache days, with some patients experiencing no migraines at all.
The study was published online October 6 in The Lancet. medscape.com 10/8/14