- April 27, 2018
- Posted by: PharmaScroll
- Category:
Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, announced new data from its PROMISE 1 Phase 3 clinical trial evaluating eptinezumab, Alder’s lead investigational product candidate for migraine prevention, in patients with episodic migraine. The clinical data demonstrated that following a quarterly infusion of eptinezumab, patients experienced a significant reduction in migraine days and improved quality-of-life outcomes. Detailed results will be presented at the 70th Annual American Academy of Neurology Meeting in Los Angeles.
“Today, a patient’s quality of life is limited by the fear of a potential migraine, which severely impacts their activities of daily living, family life and careers,” said Roger K. Cady, M.D., vice president of neurology of Alder. “The significant periods of freedom from migraine delivered in the trial represents a compelling attribute of eptinezumab’s clinical profile. These notable improvements reinforce our confidence in eptinezumab’s potential to be an important treatment option in migraine prevention.”
Key Points
- Patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1‒12, associated with 300mg dose group
- 7 percent of patients achieved a 75 percent or greater reduction in migraine days from baseline, compared to 16.2 percent for placebo, p<0.0007
- In a post hoc analysis, patients achieving a 75 percent or greater response rate had over an eight-fold increase in days between migraines
- During weeks 1‒12, the median migraine-free interval between migraine days increased from 3.9 days at baseline to 32.5 days
- Achieving a 75 percent or greater response rate was associated with more meaningful improvements in bodily pain and physical function at week 12, as measured by a quality of life patient-reported survey (SF-36)
“The significant increase in monthly migraine-free days demonstrate the potential relief that eptinezumab can deliver to migraine patients,” said Dr. Richard Lipton, Director of the Montefiore Headache Center, Albert Einstein College of Medicine. “Further, as demonstrated by the quality of life survey results, patients experienced improvements in areas such as bodily pain and physical function, illustrating the opportunity eptinezumab may provide to patients suffering from migraine.”
The observed safety profile for PROMISE 1, to date, is consistent with previously reported eptinezumab studies. The most commonly reported adverse events occurring at an incidence of 5 percent or greater across all eptinezumab treatment groups were upper respiratory infection (10.5 percent), nasopharyngitis (common cold) (6.8 percent) and sinusitis (3.6 percent).
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News Source: Alder BioPharmaceuticals website
Image Source: https://www.contractpharma.com/contents/view_breaking-news/2018-01-08/alder-biopharmas-eptinezumab-meets-primary-endpoint/11675