FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2021 Page 14
Corporate Release No 705/2021
Hormonal / neuropeptide signaling:
Eptinezumab – development and regulatory status
Eptinezumab is a monoclonal antibody (mAb) that binds to calcitonin gene-related peptide (CGRP), a neuropeptide
believed to play a key role in mediating and initiating migraines, with high specificity and potency. Eptinezumab is
administered as a quarterly 30-minute intravenous (IV) infusion, providing immediate and complete bioavailability.
In February 2020, Vyepti (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) as the
first FDA-approved IV treatment for the treatment of migraine in adults. The recommended dose is 100 mg every 3
months; some patients may benefit from a dose of 300 mg. Eptinezumab has subsequently been approved in U.A.E.,
in December 2020, in Canada, in January 2021, in Kuwait, in May 2021 and in Australia, in June 2021.
In December 2020, the filing of eptinezumab was accepted by the European Medicines Agency (EMA) for marketing
authorization application (MAA) review. The review for by the EMA’s Committee for Medicinal Products for Human
Use (CHMP) is progressing according to plan. In addition to EMA, eptinezumab has also been submitted for
regulatory review in in 13 markets; Argentina, Brazil, Chile, Indonesia, Israel, Hong Kong, Philippines, Saudi Arabia,
Singapore, South Africa, Switzerland, Thailand and the UK.
In June 2020, Lundbeck initiated the DELIVER study (NCT04418765). The purpose of this study is to evaluate
eptinezumab in the prevention of migraine in patients with unsuccessful prior preventive treatments. The patient
must have documented evidence of treatment failure (must be supported by medical record or by physician's
confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications and
have a history of either previous or active use of triptans for migraine. Patients will be randomly allocated to placebo
or two treatment groups: eptinezumab 100 mg or 300 mg given by IV infusion (n=840). The total study duration from
the screening visit to the completion visit is 76 weeks and includes a screening period (28-30 days), a placebo-
controlled treatment period (24 weeks) and a treatment extension period (48 weeks).
During the first half of 2021, Lundbeck has also started two phase III clinical trials, supporting registration in Asia,
including China and Japan. The SUNLIGHT trial (NCT04772742) evaluates the efficacy of eptinezumab to prevent
migraine and headache in patients with the combined diagnosis of chronic migraine and medication overuse
headache. Patients will be randomly allocated to placebo or eptinezumab 100 mg given by IV infusion (n = 182).
The total study duration is approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-
controlled Period (12 weeks), an Open-Label Period (12 weeks) and a Safety Follow-up Period (8 weeks). The
SUNRISE trial (NCT04921384) evaluates the efficacy of eptinezumab to prevent migraine and headache in patients
with chronic migraine. Patients will be randomly allocated to placebo or two treatment groups; eptinezumab 100 mg
or 300 mg given by IV infusion (n=513). The total study duration is either approximately 36 weeks, including
screening period and safety follow-up; or 24 weeks for patients in Japan that enter into a separate open label
extension trial.
In December 2020, Lundbeck initiated a phase III clinical study investigating the efficacy of eptinezumab in patients
with episodic cluster headache (ALLEVIATE). The study (NCT04688775) is planned to recruit around 300 patients
that will be randomly assigned to receive, in a blinded manner, two infusions of either eptinezumab or placebo in a
cross-over manner during the placebo-controlled period and active treatment period of the study. The total duration
of the study is 24 weeks, including a safety follow up period of 8 weeks.
Lu AG09222 – phase I
Lu AG09222 (former ALD 1910) is a monoclonal antibody (mAb) designed to bind pituitary adenylate cyclase-
activating polypeptide (PACAP), thereby effectively preventing PACAP from activating its receptors. PACAP has