Novartis announced detailed Phase II results showing the fully human monoclonal antibody AMG 334 (erenumab) demonstrated a statistically significant reduction in monthly migraine days compared with placebo in patients with chronic migraine (CM). Significantly more patients receiving monthly subcutaneous AMG 334 70mg or 140mg experienced a 50% or more reduction in the number of monthly migraine days compared with placebo (40%, 41% and 24%, respectively).The data are being presented at the 5th European Headache and Migraine Trust International Congress (EHMTIC) in Glasgow, Scotland.
“This is an exciting time in the treatment of chronic migraine, which has a profound impact on the lives of those who suffer from the disease,” said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. “These important data further support the efficacy of AMG 334 in patients who currently have limited therapeutic options.
The study included 667 patients who had a mean baseline of approximately 18 migraine days per month, and were randomized to receive either subcutaneous placebo or subcutaneous AMG 334 70mg or 140mg once a month.Across both doses, patients observed a statistically significant 6.6-day reduction from baseline in monthly migraine days compared with 4.2 days observed in those on placebo (p<0.001). A reduction of 50% or more in number of monthly migraine days was observed in 40% and 41% (70mg and 140mg doses, respectively) of individuals in the AMG 334 groups, representing a significantly higher likelihood of response compared to 24% of those receiving placebo (both p<0.001).All endpoint assessments compared the last four weeks of the 12-week treatment phase to baseline.
Other key secondary endpoints results from the Phase II CM study are:
The safety profile of AMG 334 was similar to placebo across both treatment arms.No adverse event was reported in greater than five percent of patients treated with AMG 334. The most common adverse events (in placebo, 70mg AMG 334 and 140mg AMG 334 groups, respectively) were injection site pain (1.1%, 3.7% and 3.7%), upper respiratory tract infection (1.4%, 2.6% and 3.2%) and nausea (2.5%, 2.1% and 3.2%).
Migraine is the most prevalent of all neurological disorders, with more than 10% of the worldwide population affected.It profoundly limits patients’ abilities to carry out everyday tasks and as such, the World Health Organization has declared migraine to be one of the top ten causes of disability for men and women.CM is characterized by at least 15 headache days per month, of which eight or more days have migraine features, for more than three months.It is the most debilitating form of migraine, and it is challenging for healthcare professionals to treat. As such, CM patients experience a substantial negative impact on daily activities and quality of life.
Results from Phase III studies investigating AMG 334 in episodic migraine are expected later this year. AMG 334 is being co-developed by Amgen and Novartis. As part of the collaboration, Amgen retained commercialization rights in the U.S., Canada and Japan, and Novartis has rights in Europe and rest of world.
Assessment tools for exploratory endpoints included the Headache Impact Test (HIT-6(TM)), Migraine Disability Assessment (MIDAS), Migraine-Specific Quality-of-Life Questionnaire (MSQ), and the Patient Reported Outcome Measurement Information System (PROMIS®) Pain Interference Scale Short Form. Exploratory endpoints were not adjusted for multiple comparisons.