Date: 2017-04-28
Type of information: Presentation of results at a congress
phase: 2b
Announcement: presentation of results at the 69th Annual American Academy of Neurology Meeting
Company: Alder Biopharmaceuticals (USA - WA)
Product: eptinezumab - ALD403
Action mechanism: monoclonal antibody. Eptinezumab (ALD403) was discovered by Alder scientists and has been evaluated in multiple clinical trials evaluating approximately 800 patients. In a proof-of-concept clinical trial evaluating patients with frequent episodic migraine, ALD403 demonstrated significant prevention of migraines, including complete migraine relief (100% suppression of migraine occurrence) in 27% to 41% of patients in any given month. Migraines were completely prevented in 16% of patients for the entire three-month study period. ALD403 also has a favorable emerging safety profile, demonstrating a similar level of safety to placebo, and has been well-tolerated in studies to date.
Disease: chronic migraine
Therapeutic area: CNS diseases - Neurological diseases
Country:
Trial details: The study was a parallel group, double-blind, randomized, placebo controlled, dose-ranging Phase 2b trial to evaluate the efficacy, safety and pharmacokinetics of eptinezumab (ALD403) administered intravenously in patients with chronic migraine. The study enrolled 616 patients across 90 sites, stratified into four experimental dose groups: 10 mg ALD403, 30mg ALD403, 100 mg ALD403, 300 mg ALD403, and a placebo group. The primary endpoint was the reduction in migraine days as measured by the 75% responder rates from baseline to week 12, and secondary endpoints included the evaluation of safety and pharmacokinetics.
Latest news: • On April 28, 2017, Alder BioPharmaceuticals announced the presentation of positive data from its Phase 2b clinical trial evaluating eptinezumab (formerly ALD403) for the prevention of migraine. Key findings from the study showed that chronic migraine patients treated with a single infusion of eptinezumab (ALD403) experienced a significant reduction in migraine days as measured by 75% responder rates, with maximum efficacy in 1 to 4 weeks that was maintained through 12-weeks. Post hoc analysis of the trial data also suggested that a single administration led to a clinically meaningful reduction in the percentage of patients experiencing migraine within 24 to 48 hours post infusion. These data and additional study results are the topic of a podium presentation titled - "Randomized, Double-Blind, Placebo-Controlled Trial of ALD403 (Eptinezumab), an Anti-CGRP Peptide Antibody, in the Prevention of Chronic Migraine" presented at the 69th Annual American Academy of Neurology (AAN) meeting in Boston. Alder Biopharmaceuticls is on track to report top-line results from its first Phase 3 pivotal trial of eptinezumab later this quarter. Key Points: A single administration of eptinezumab (ALD403) significantly reduced migraine days in patients with chronic migraine as measured by 75% responder rates. It produced a reduction in the number of patients experiencing migraine within 24 to 48 hours post infusion. It also resulted in 1/3 of patients achieving a 75% reduction in their migraine days in Weeks 1-4 that was maintained through Week 12. Eptinezumab demonstrated a tolerability and safety profile similar to placebo, with no serious adverse events deemed treatment related or infusion reactions observed.
