Valby (15 November, 2021) — H. Lundbeck A/S (Lundbeck), announced that it has expanded its clinical mid-stage pipeline with the initiation of the HOPE study, a randomized, double-blind, phase II, proof of concept, study to assess efficacy, safety, and tolerability of Lu AG09222 as a treatment for the prevention of migraine. Lu AG09222 is an investigational monoclonal antibody (mAb) that is designed to bind and inhibit signaling mediated by pituitary adenylate cyclase-activating polypeptide (PACAP); a neuropeptide that is implicated in migraine pathophysiology. Earlier this year, Lu AF82422 was granted orphan drug designation by the European Medicines Agency (EMA), and the AMULET study has now been approved by the FDA and is ready to enroll the first patient.
Lu AG09222 represents a potential new therapeutic option, targeting a pathway in migraine that is distinct from the recently available calcitonin gene-related peptide (CGRP) migraine treatment drug class. PACAP and its receptors are broadly expressed in the nervous system, including at sites implicated in migraine pathophysiology. In pre-clinical and clinical studies in healthy subjects, Lu AG09222 has shown to bind with high affinity to PACAP, thereby preventing PACAP from activating its receptors.
Dr. Johan Luthman, EVP and Head of Research & Development in Lundbeck, said: “Initiation of this phase II study of Lu AG09222 advances our neurology pipeline by adding another program in phase II, as well as further expands our investment in biotherapeutics. We believe inhibition of PACAP is a promising pathway in addressing migraine, and I am excited about the potential of Lu AG09222 to possibly help patients who may require a new approach for the prevention of migraine.”
The HOPE study, a phase II double-blind, placebo-controlled study of Lu AG09222, is planned to enroll approximately 230 patients and will assess the efficacy, safety, and tolerability of Lu AG09222 at two doses. Study completion is expected in 2023.
The HOPE study is an interventional, multi-national, multi-site, randomized, double-blind, parallel-group, placebo-controlled phase IIa study designed to demonstrate proof-of-concept, that is, to investigate whether the inhibitory action of Lu AG09222 on the PACAP pathway can be an effective mechanism for migraine prevention.
The target population for this study is defined as patients diagnosed with migraine as outlined in the International Classification of Headache Disorders Third Edition (ICHD-3)i. A total of 230 patients, recruited from specialist settings, will be randomly allocated via a randomization system to one of three treatment groups: two doses of Lu AG09222 or placebo.
Lundbeck is developing Lu AG09222 an investigational monoclonal antibody (mAb) designed to bind and inhibit pituitary adenylate cyclase-activating polypeptide (PACAP)ii. PACAP has emerged as a neuropeptide implicated in the pathophysiology of migraine and represents a novel target in migraine. Lu AG09222 may hence provide value as a preventive treatment in patients with migraine.
Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of moderate to severe, pulsating headaches typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light and soundiii. As the most prevalent neurological disorder in people aged <50 years, migraine imposes both a social and financial burden, affecting around 135 million people in the G7 countries plus China. Repeated migraine attacks, and often the constant fear of the next one, damage family life, social life, and work lifeiv.
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H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
Too many people worldwide live with brain diseases – complex conditions often invisible to others that nonetheless take a tremendous toll on individuals, families and societies. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Every day, we strive for improved treatment and a better life for people living with brain disease.
We have approximately 5,600 employees in more than 50 countries, and our products are available in more than 100 countries. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17.7 billion in 2020 (EUR 2.4 billion; USD 2.7 billion).
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i Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd Edition. Cephalalgia, 2018. 38(1): p. 1-211.
ii Moldovan Loomis, C., et al., Pharmacologic Characterization of ALD1910, a Potent Humanized Monoclonal Antibody against the Pituitary Adenylate Cyclase-Activating Peptide. J Pharmacol Exp Ther, 2019. 369(1): p. 26-36.
iii Headache Classification Committee of the International Headache Society (IHS). The International Classification of.Headache Disorders, 3rd Edition. Cephalalgia, 2018. 38(1): p. 1-211.
iv Burch, R.C., D.C. Buse, and R.B. Lipton, Migraine: epidemiology, burden, and comorbidity. Neurol Clin, 2019.37(4): p. 631-649.