Alder BioPharmaceuticals, Inc. (ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced new one-year efficacy data from the PROMISE 1 Phase 3 clinical trial in patients with episodic migraine. The data demonstrate that patients experienced even further reductions in monthly migraine days (MMDs) following the third and fourth quarterly infusions of eptinezumab, Alder’s lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide (CGRP). Detailed results will be presented today at the 60th AHS Annual Scientific Meeting in San Francisco, CA.
“The encouraging and consistent results from the PROMISE 1 trial showing that eptinezumab provided both immediate and long-term efficacy over a period of a year, reinforce our confidence in eptinezumab’s potential to be a meaningful new treatment option for migraine prevention,” said Robert Azelby, chief executive officer of Alder. “These data further validate the significance of our clinical program and underscore Alder’s commitment to transform the treatment paradigm for migraine prevention for patients whose quality of life is severely impacted by this debilitating disease.”
Highlights from PROMISE 1 Trial Following Third and Fourth Eptinezumab Infusions:
- Following the first quarterly infusion, patients treated with 300 mg experienced 4.3 fewer MMDs from a baseline of 8 MMDs, compared to 3.2 fewer MMDs for placebo from baseline (p value = 0.0001). At one year after the third and fourth quarterly infusions, patients treated with 300 mg experienced further gains in efficacy with a reduction of 5.2 fewer MMDs compared to 4.0 fewer MMDs for placebo-treated patients.*
- Approximately, 31 percent of patients achieved, on average per month, 100 percent reduction of migraine days from baseline compared to approximately 21 percent for placebo. This means that almost one-third of patients, on average, experienced monthly migraine freedom when treated with 300 mg of eptinezumab.
- There were no new safety findings observed with the third and fourth quarterly infusions.
“These data are very encouraging, especially for the majority of my patients who have struggled to find relief from traditional treatment options and have discontinued use either due to lack of efficacy or side effects,” said Stephen D. Silberstein, M.D., professor of neurology and director of the Jefferson Headache Center, Thomas Jefferson University. “I look forward to the promise of a potential treatment that not only shows a strong efficacy profile, but also demonstrates that the benefit may even further improve after each dose.”
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 2.0 percent or greater across all eptinezumab treatment groups and greater than placebo were: upper respiratory tract infection (10.5 percent), nasopharyngitis (common cold) (6.8 percent), fatigue (3.2 percent), diarrhea (2.3 percent) and oropharyngeal (mouth) pain (2.0 percent).
Migraine is a highly symptomatic and debilitating disease affecting a large patient population.1 Preventative treatments, if effective, may take weeks to months to achieve meaningful clinical benefits, and fail to meet the needs of most patients.2 Further, up to 80 percent of patients discontinue use within six months to a year due to lack of efficacy and/or side effects.3,4
Eptinezumab is an investigational monoclonal antibody discovered and developed by Alder BioPharmaceuticals for migraine prevention. Eptinezumab is the only potent and selective anti-CGRP mAb administered by quarterly infusion for migraine prevention, delivering 100 percent bioavailability to immediately inhibit CGRP.5 Eptinezumab has been studied in several global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention.
About Eptinezumab PROMISE Clinical Trial Program
PROMISE 1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy 1) was a Phase 3 randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for episodic migraine prevention. In the study, patients were randomized and 888 received eptinezumab (300 mg, 100 mg or 30mg), administered by infusion once every 12 weeks. To be eligible for the trial, patients must have experienced at most 14 headache days per month, of which at least four met the criteria for migraine. The primary endpoint was the mean change from baseline in monthly migraine days over the 12 week treatment period. Secondary study endpoints assessed through 12 weeks include at least 75 percent and at least 50 percent responder rates, proportion of patients experiencing migraine on the day following administration, and those assessed through week 24 include at least 75 percent and 100 percent responder rates. In June 2017, Alder announced that eptinezumab met the primary endpoint and key secondary endpoints in PROMISE 1 with very high statistical significance. See the press release for more information.