PROMISE Phase 3 Trial for Chronic Migraine Prevention Meets Primary and All Key Secondary Endpoints; Shows Reduction in Migraine Risk

Monday, January 08, 2018 | Clinical Trials , Headache & Pain , Phase 3/4 Trials


January 8, 2018--Alder Biopharmaceutical reported that their injectable calcitonin-gene-related peptide (CGRP)-inhibitor eptinezumab, in phase 3 clinical trials, reduced monthly migraine days by 50% or more in 3 of 5 patients treated, and that 33% had ≥ 75% reduction in headache days per month with a 52% reduction in migraine risk beginning on day 1. Eptinezumab is a monoclonal antibody that targets CGRP. Alder plans to file a biologics license application in the second half of 2018. If approved, eptinezumab will be the first infusion therapy approved for migraine. 

 

As announced in 2017, the first of two phase 3 trials, PROMISE 1 and 2, both of which are double-blind, randomized, placebo-controlled studies had shown that eptinezumab significantly reduced the number of migraine days per month versus placebo.

 

The second phase 3 trial, PROMISE 2 enrolled 1,072 patients who met the International Headache Congress’ definition of chronic migraine: 15 or more headache days per month in which at least 8 headache days include characteristics of migraine. Treatment with eptinezumab reduced the number of headache days from a baseline of 16.1 days per month to 7.9 days per month over the 12-week treatment period versus a reduction to 10.5 days with placebo (P = .0001). In addition, 33% of patients had at least a 75% reduction in headache days per month compared to 15% for placebo (P < .0001). Rapid prevention was also achieved; there was a 52% reduction in migraine risk beginning on day 1 after infusion compared to 27% for placebo (P < .00011). Safety and tolerability findings were similar to those in previously reported eptinezumab studies.

 

“These results represent an important part of the significant step forward that patients who suffer from migraine. . . are about to experience,”  said Peter Goadsby, MD, PhD DSc, Neurologist and Headache Specialist at the University of California, San Francisco Medical Center, stating that rapid onset of sustainable benefits after one administration represented a “paradigm shift” in migraine preventive treatment with the potential for “patients to experience early and meaningful periods of migraine freedom if new treatments become approved.”

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