An experimental therapy being developed by Amgen and Novartis to prevent chronic migraine has hit its primary targets in a late-stage trial, further raising hopes for a new treatment option for the condition.
The first six-month placebo-controlled study of AMG 334 (erenumab) in migraine met its primary endpoint, showing a statistically significant reduction in monthly migraine days with both doses tested versus placebo.
Patients enrolled in STRIVE were randomised to receive either placebo or AMG 334 at 70mg or 140mg doses, subcutaneously, once monthly, for six months. At baseline, patients experienced between four and 14 migraine days each month, with an average of 8.3 migraine days. Those taking 70mg and 140mg AMG 334 treatment arms experienced a statistically significant 3.2-day and 3.7-day reduction from baseline in mean monthly migraine days, respectively, as compared to a 1.8-day reduction in the placebo arm, the data show.
On the safety side, AMG 334 was comparable to placebo across both treatment arms over the six-month double-blind evaluation, the most frequently reported adverse events being nasopharyngitis, upper respiratory tract infection and sinusitis, Novartis noted.
AMG 334 is a fully human monoclonal antibody specifically designed to target and block the Calcitonin Gene-Related Peptide (CGRP) receptor, which is thought to play a key role in mediating the incapacitating pain of migraine, a leading cause of disability that affects more than 10 percent of people worldwide.
Amgen and Novartis are now pursuing discussions with regulatory agencies for potential filings next year in their respective territories (the US Canada and Japan, and Europe and rest of word, respectively).