Announcement • Jun 05

H. Lundbeck Presents Positive Phase IIb Data For Bocunebart In Migraine Prevention

H. Lundbeck A/S presented primary data from the Phase IIb PROCEED trial evaluating bocunebart (Lu AG09222), an investigational monoclonal antibody targeting pituitary adenylate cyclase-activating polypeptide (PACAP). The intravenous part of the Phase IIb clinical dose-finding trial PROCEED met its primary endpoint, with bocunebart demonstrating a statistically significant reduction in monthly migraine days versus placebo over Weeks 1–12 in patients with one to four prior preventive treatment failures. Bocunebart was generally well tolerated, with no new safety signals identified. The totality of the presented clinical data from the bocunebart Phase I-IIb program strengthens the evidence for PACAP pathway inhibition as a novel therapeutic approach for people severely impacted by migraine. Bocunebart is designed to bind to and inhibit PACAP, a neuropeptide implicated in migraine pathophysiology through pathways distinct from calcitonin gene-related peptide (CGRP). This differentiated mechanism positions bocunebart as a potential alternative treatment option for patients who do not achieve adequate benefit from currently available preventive therapies. In the intravenous (IV) dosing part of the PROCEED trial, bocunebart met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days (MMDs) over Weeks 1–12 compared with placebo. Patients treated with bocunebart experienced a mean reduction of -4.24 monthly migraine days versus -2.86 days with placebo, corresponding to a treatment difference of -1.38 days (p=0.0178). In pooled data across the Phase II program of severe, chronic migraine patients, bocunebart showed a more pronounced effect with a mean reduction of -5.94 MMDs versus -3.63 MMDs with placebo, corresponding to a treatment difference of -2.31 days. The PROCEED trial assessed the efficacy, safety, and tolerability of bocunebart versus placebo when administered once monthly for three months. The Phase IIb trial was designed to establish the optimal dose and route of administration (subcutaneous and intravenous) of bocunebart. A predefined interim analysis of the subcutaneous part of the PROCEED trial demonstrated futility and triggered enrolment into the intravenous (IV) part of the trial. In the IV part of PROCEED a total of 429 patients from 14 countries (Bulgaria, Czechia, Denmark, France, Georgia, Germany, Hungary, Lithuania, Japan, Poland, Romania, Slovakia, Spain, and the United States) were treated. The primary efficacy endpoint was defined as the difference between bocunebart and placebo in mean change from baseline in the number of monthly migraine days over Weeks 1 to 12. The target population for this trial included patients diagnosed with migraine according to the International Classification of Headache Disorders, Third Edition (ICHD-3), who had experienced treatment failure with one to four different preventive migraine medications within the past 10 years. The HOPE trial was an interventional, multi-national, multi-site, randomized, double-blind, parallel-group, placebo-controlled Phase IIa trial designed to assess the safety, tolerability and efficacy of a single IV infusion of bocunebart for the prevention of migraine in patients that had failed prior treatments. The trial consisted of a 4-week double-blind treatment period with a follow-up period for 8 weeks. The primary endpoint was the change from baseline in the number of monthly migraine days over weeks 1 to 4, compared to placebo. Secondary endpoints were =50% reduction from baseline in MMDs (Weeks 1 to 4) and change from baseline in the number of monthly headache days (Weeks 1 to 4), compared to placebo. The target population for this trial was defined as patients diagnosed with migraine as outlined in the International Classification of Headache Disorders Third Edition (ICHD-3) with unsuccessful prior preventive treatments. A total of 237 patients, recruited from specialist settings, were randomly allocated via a randomization system to one of three treatment groups: two doses of bocunebart or placebo. Bocunebart is an investigational monoclonal antibody (mAb) with a novel mechanism of action. It is designed to bind to and inhibit the signalling of pituitary adenylate cyclase-activating polypeptide (PACAP), a neuropeptide implicated in migraine pathophysiology. This mechanism operates through a pathway distinct from that targeted by anti-calcitonin gene-related peptide (anti-CGRP) therapies. Bocunebart represents a potential new treatment class in migraine prevention and may provide an alternative option for people living with migraine who continue to be severely affected by the condition. Bocunebart is an investigational drug that is not approved for marketing by any regulatory authority worldwide, and the efficacy and safety of bocunebart have not been established.

Announcement • May 27

H. Lundbeck A/S Receives Marketing Authorization for Vyepti (Eptinezumab) in South Korea for Preventive Treatment of Migraine

H. Lundbeck A/S has been granted marketing authorization for eptinezumab for use in adults with migraine by the Ministry of Food and Drug Safety (MFDS) of South Korea. Eptinezumab is an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody for the preventive treatment of migraine in adults. Authorization was supported by the Phase 3 SUNRISE trial conducted in a predominantly Asian population with chronic migraine. Eptinezumab is a humanized monoclonal antibody that binds to CGRP and was intentionally designed for intravenous (IV) administration. The decision is based on results from the confirmatory Phase 3 trials PROMISE-1, PROMISE-2, DELIVER and SUNRISE. The latter trial, SUNRISE, was a randomized, placebo-controlled trial conducted in a predominantly Asian population with chronic migraine. Eptinezumab was first approved by the U.S. Food and Drug Administration for the preventive treatment of migraine in adults, followed by additional approvals including in the European Union. It has since been launched in more than 30 markets worldwide. Migraine is a progressive and debilitating neurological disease characterized by recurrent attacks of severe headache often accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine affects one in seven people and is a leading cause of disability worldwide. Approximately 11% of the population in Korea currently lives with migraine, a figure that may be underestimated. Despite its high prevalence, preventive treatments are often underutilized. Significant gaps remain in diagnosis, access to care, and effective treatment options. Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was intentionally designed for IV administration. The efficacy and safety of eptinezumab were evaluated in two Phase 3 clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine), where eptinezumab met its primary endpoint of decrease in monthly migraine days (MMDs) over weeks 1-12 in both episodic and chronic migraine. Furthermore, the clinical trial program demonstrated a treatment benefit over placebo that was observed for both 100 mg and 300 mg doses of eptinezumab as early as Day 1 post-infusion. The safety of eptinezumab was evaluated in more than 2,000 adult patients with migraine who received at least one dose of eptinezumab. The most common adverse reactions (=2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with eptinezumab discontinued treatment due to adverse reactions. VYEPTI (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Commission (EC) for the prophylaxis of migraine in adults who have at least four migraine days per month. Eptinezumab is launched in more than 30 markets worldwide.

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