New twelve-month data from a phase 3 clinical trial of eptinezumab in episodic migraine patients has been released. The results show that patients experienced even further reductions in migraine following the third and fourth quarterly infusions at both dose levels (100mg and 300mg) of the drug, Alder’s lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide (CGRP).
CGRP is produced in both peripheral and central neurons. It is a potent peptide vasodilator and can function in the transmission of nociception.
“These results show eptinezumab’s potential to further reduce migraine risk after 12 months and reinforces the demonstrated clinical profile for migraine prevention from our earlier PROMISE 1, 6-month data. The strength of the data supports our belief that eptinezumab, if approved, has the potential to be an important treatment option for the millions of patients living with the debilitating effects of migraine.”
said Roger K. Cady, M.D., Alder Vice President of Neurology.
Eptinezumab PROMISE Clinical Trial
PROMISE 1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy 1) was a Phase 3 randomized, double-blind, placebo-controlled global trial evaluating safety and efficacy for episodic migraine prevention. In the study, 888 patients were randomized to receive eptinezumab (300 mg, 100 mg or 30mg), or placebo administered by infusion once every 12 weeks.
To be eligible for the trial, patients had to have experienced 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, double-blind treatment period.
In June 2017, Alder announced that eptinezumab met the primary endpoint and key secondary endpoints in PROMISE 1 with very high statistical significance.
In the latest data, responder rates for month six through month twelve were:
- 70.7 percent of patients achieved on average a 50 percent reduction or greater of monthly migraine days from baseline compared to 58.7 percent for placebo. This represents an 8.9% improvement from the reductions experienced during the first two quarterly doses of eptinezumab
- 51.5 percent of patients achieved on average a 75 percent reduction or greater of monthly migraine days from baseline compared to 38.7 percent for placebo. This represents a 12.8% improvement from the reductions experienced during the first two quarterly doses of eptinezumab
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).
“I am very excited to see the encouraging results in migraine prevention shown in the PROMISE 1 long-term data. I see a significant need for my patients for a treatment that provides rapid, effective, well-tolerated and long-term results and I’m looking forward to the FDA’s review of these data,”
said Stephen D. Silberstein, M.D., Professor of Neurology and Director of the Jefferson Headache Center, Thomas Jefferson University.
Joel Saper, Richard Lipton, David Kudrow, Joe Hirman, David Dodick, Stephen Silberstein, George Chakhava, Jeff Smith
Primary Results of PROMISE-1 (Prevention Of Migraine via Intravenous eptinezumab Safety and Efficacy–1) Trial: a Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab for Prevention of Frequent Episodic Migraines (S20.001)
Neurology Apr 2018, 90 (15 Supplement) S20.001
Timothy Smith, David Biondi, Gary Berman, Marshall Freeman, Joe Hirman and Eric Kassel
Eptinezumab Achieved Meaningful Reductions in Migraine Activity Within 24 Hours That Were Sustained Through Week 12: Results From PROMISE-1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy-1) Phase 3 Trial (P4.092)
Neurology Apr 2018, 90 (15 Supplement) P4.092;