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Alder Biopharmaceuticals announces results of Phase III PROMISE study of eptinezumab for migraine prevention.

Read time: 1 mins
Last updated:29th Jun 2017
Published:29th Jun 2017
Source: Pharmawand

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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