Eptinezumab: Designed for Migraine Prevention

Eptinezumab (formerly known as ALD403) is our pivotal-stage monoclonal antibody (mAb) that inhibits calcitonin gene-related peptide (CGRP), a neuropeptide that plays an important role in migraine pathophysiology.8 Eptinezumab is currently in late-stage clinical development and, if approved, will be the first-to-market infusion therapy for migraine prevention.

Eptinezumab was designed to selectively bind to the CGRP ligand with high affinity to block its effect at all CGRP receptors.9 In clinical studies, eptinezumab is being evaluated as a quarterly infusion allowing the total dose administered to be immediately active to inhibit CGRP with 100% bioavailability.9

Clinical Development Program

Eptinezumab is currently being studied in multiple global, randomized, pivotal, Phase 3 trials to assess its efficacy and safety in migraine prevention. To date, more than 3,100 patients have been included in the clinical development program.

STUDY STATUS
PROMISE 1 - Phase 3 study in frequent episodic migraine10 Ongoing
PROMISE 2 - Phase 3 study in chronic migraine11 Ongoing

Open-label safety study

Ongoing

8Ho TE, et al. CGRP and its receptors provide new insights into migraine pathophysiology. Nat Rev Neurol. 2010;6:573-82.

9Baker B, Schaeffler B, Cady R, et al. Rational design of a monoclonal antibody (mAb) inhibiting calcitonin gene-related peptide, ALD403 (eptinezumab), intended for the prevention of migraine. Poster presented at the American Academy of Neurology (AAN) 2017 Annual Meeting.

10Saper JR, Lipton RB, Kudrow DB, et al. A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab in Frequent Episodic Migraine Prevention: Primary Results of the PROMISE-1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy–1) Trial; Poster presented at the International Headache Congress September 2017.

11Lipton R et al. A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab for the Preventive Treatment of Chronic Migraine: Results of the PROMISE-2 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy-2) Trial. Clinical Trials Plenary Presentation at the American Academy of Neurology (AAN) 2018 Annual Meeting.