Eptinezumab: Designed for Migraine Prevention

Eptinezumab (formerly known as ALD403) is our pivotal-stage monoclonal antibody (mAb) designed to inhibit calcitonin gene-related peptide (CGRP), a neuropeptide that plays an important role in migraine pathophysiology.9

Delivered by quarterly infusion, eptinezumab was designed for 100% bioavailability with high specificity and strong binding for rapid, robust and sustained suppression of CGRP.10,11 It binds to the CGRP ligand to prevent activation of the CGRP receptors.10 In clinical trials, eptinezumab demonstrated a differentiated clinical profile with clinically meaningful outcomes, including quality of life benefits.12-17

The U.S. Food and Drug Administration accepted Alder’s Biologics License Application (BLA) for eptinezumab in April 2019, with a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2020. If approved, eptinezumab will be the first quarterly, anti-CGRP infusion therapy for migraine prevention.

Clinical Development Program

Eptinezumab has been studied in multiple global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in both chronic and episodic 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 migraine12 Complete
PROMISE 2 - Phase 3 study in chronic migraine13 Complete

Open-label safety study

Ongoing

9. Walker CS, Hay DL. CGRP in the trigeminovascular system: a role for CGRP, adrenomedullin and amylin receptors? Br J Pharmacol 2013;170:1293-1307.

10. Baker B, Schaeffler B, Cady R, et al. Rational design of a monoclonal antibody (mAb) inhibiting calcitonin gene-related Peptide (CGRP), ALD403, intended for the prevention of migraine (P2.155). Neurology. 2017;88(16 Supplement):P2.155.

11. Data on File, Alder BioPharmaceuticals.

12. Saper J, Lipton R, Kudrow D, 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. Cephalalgia. 2017;37(1 suppl):319-374.

13. Lipton R, Saper J, Ashina M 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. Neurology. 2018;90 (15 Supplement).

14. Silberstein S, Kudrow D, Saper J et al. Eptinezumab results for the prevention of episodic migraine over 1 year in the PROMISE-1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy–1) trial. Presented at AHS 60th Annual Meeting, June 28 – July 1, 2018; San Francisco, California.

15. Lipton R, Saper J, Ashina M et al. A phase 3 study to evaluate eptinezumab for preventive treatment of chronic migraine: Results of PROMISE-2 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy-2) trial. Presented at AHS 60th Annual Meeting, June 28 – July 1, 2018; San Francisco, California.

16. Saper J, Wilks K, Chakhava G et al. Eptinezumab for the prevention of episodic migraine through 1 year. Results of the phase 3 PROMISE-1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy–1) trial. Presented at the 2019 AAN Annual Meeting, May 4 – 10, 2019; Philadelphia, Pennsylvania.

17. Lipton R, Goadsby P, Azimova J, et al. Eptinezumab for prevention of chronic migraine: results of 2 quarterly intravenous infusions in the phase 3 PROMISE-2 (Prevention Of Migraine via Intravenous eptinezumab Safety and Efficacy-2) trial. Presented at AHS 60th Annual Meeting, June 28 – July 1, 2018; San Francisco, California.