Alder Biopharmaceuticals announces results of Phase III PROMISE study of eptinezumab for migraine prevention.
Alder BioPharmaceuticals, Inc.,announced that eptinezumab, its lead product candidate for migraine prevention, met the primary and key secondary endpoints in PROMISE 1, a Phase III pivotal clinical trial evaluating patients with frequent episodic migraine.
PROMISE 1 Highlights: PROMISE 1 met the primary endpoint: highly statistically significant reductions in monthly migraine days; Significant Day 1 clinical benefit: more than 50% reduction in the proportion of patients experiencing a migraine on Day 1 post-dose; Significant 75% responses at all key time points: 1/3 of patients achieved a greater than 75% reduction in migraine days through 4 and 12 weeks; Average of 1 in 5 patients had 100% response: no migraines in any given month, months 1 through 6; and The safety profile was similar to placebo: consistent with previously reported eptinezumab studies.
Comment:Treatment with a 300 mg dose of eptinezumab significantly reduced the number of monthly migraine days from baseline by 4.3 days over a three-month period. Patients studied in PROMISE-1 had frequent episodic migraine, defined as 14 headache days or less per month. But a high placebo response of 3.2 days translated to a placebo-adjusted lowering of 1.1 days, less than the near 2-day reductions seen in studies testing similar drugs from Eli Lilly & Co. and the team of Amgen and Novartis.
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