Clinical Trials

Date: 2016-11-28

Type of information: Initiation of the trial

phase: 3

Announcement: initiation of the trial

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:

Disease: chronic migraine

Therapeutic area: CNS diseases - Neurological diseases

Country: Belgium, Georgia, Hungary, Russian Federation, Slovakia, Spain, Ukraine, USA

Trial details: The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of migraine headache in chronic migraineurs. (NCT02974153)

Latest news:

• • On November 28, 2016, Alder BioPharmaceuticals announced the initiation of PROMISE 2 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2), the second pivotal Phase 3 clinical trial of eptinezumab (formerly known as ALD403), its monoclonal antibody candidate inhibiting calcitonin gene-related peptide (CGRP), for the prevention of migraine. Alder also announced that eptinezumab was selected as the International Nonproprietary Name for ALD403.
• Alder Biopharmaceuticals intends to advance eptinezumab toward a planned BLA submission in 2018. The PROMISE 2 pivotal study will evaluate the safety and efficacy of eptinezumab in patients with chronic migraine. The double-blind, randomized, placebo-controlled trial will evaluate two dose levels of eptinezumab administered by infusion once every 12 weeks in approximately 1,050 individuals with chronic migraine.
• The primary endpoint of the trial is the mean reduction in migraine days from baseline over weeks 1 to 12. Key secondary endpoints are the 75% responder rate over weeks 1 to 12 as determined by the change in migraine days between eptinezumab and placebo, and the 75% responder rate over weeks 1 to 4 as determined by the change in migraine days between eptinezumab and placebo. Top-line data from PROMISE 2 is expected in the first half of 2018.
• In addition to PROMISE 2, the eptinezumab pivotal trial program consists of PROMISE 1 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 1), Alder's ongoing pivotal study evaluating eptinezumab in approximately 800 patients with frequent episodic migraine, and a planned open-label study. The open-label study is intended to confirm the long-term safety and tolerability of eptinezumab, as required by the FDA. This study is expected to begin in the first quarter of 2017 and will enroll approximately 120 patients that will receive eptinezumab administered by infusion every 12 weeks for one year. The results of PROMISE 1, PROMISE 2 and the open-label study will support a Biologics License Application (BLA) submission to the FDA for the infusion formulation of eptinezumab.

Is general: Yes