migraine prevention aiming to establish the optimal
dose for future global pivotal trials.
In June 2024, Lundbeck initiated a first trial with Lu
AG13909 in patients with Cushing’s disease (CD).
In June 2024, the U.S. Food and Drug Administration,
FDA, accepted a supplemental new drug application,
sNDA, filing for brexpiprazole in combination with
sertraline for the treatment of adults with post-trau-
matic stress disorder (PTSD). The FDA plans to host a
Psychopharmacologic Drugs Advisory Committee
meeting to seek input on issues related to the sNDA.
The meeting is anticipated to occur during the first
half of 2025. If the application, is approved, the brex-
piprazole and sertraline combination treatment
would be the first FDA-approved pharmacological
treatment for PTSD in more than 20 years.
In October 2024, Lundbeck initiated the first clinical
trial of its CD40L blocker, Lu AG22515, in patients.
The proof-of-concept (PoC) trial will evaluate the effi-
cacy, safety, and tolerability of Lu AG22515 as a po-
tential treatment for Thyroid Eye Disease, an autoim-
mune disease causing a debilitating, disfiguring, and
potentially blinding periocular condition. Blocking
CD40L inhibits both B and T cell activations without
direct clearance of B cell populations and holds
strong promise in treating a wide range of autoim-
mune-related CNS disorders.
In October, Lundbeck announced positive results
from the SUNRISE phase III pivotal trial of Vyepti
®
(eptinezumab) in migraine prevention. Vyepti
®
con-
firmed efficacy, meeting the primary and all key sec-
ondary endpoints. SUNRISE was predominantly con-
ducted in Asia, evaluating the efficacy and safety in
patients with chronic migraine. Based on the trial re-
sults, Lundbeck plans to initiate discussions with rel-
evant regulatory authorities with the aim of making
Vyepti
®
available for people suffering from migraine
across Asia.
Epilepsy back in the pipeline
In 2024, Lundbeck acquired Longboard Pharmaceu-
ticals with the lead asset bexicaserin which holds
blockbuster potential. In September 2024, a global
phase III trial was initiated by Longboard Pharma-
ceuticals, evaluating bexicaserin for the treatment of
seizures associated with Dravet Syndrome, one of
the rare epilepsies. In November, Longboard Phar-
maceuticals initiated a second phase III to evaluate
the efficacy of bexicaserin in Developmental and Epi-
leptic Encephalopathies (DEEs).
Bexicaserin has shown encouraging anti-seizure ef-
fects to date in preclinical and clinical studies, with
its next-generation superagonist mechanism specifi-
cally targeting 5-HT
2C
receptors, supporting bexi-
caserin’s potential to offer a highly differentiated
and best-in-class profile. It complements perfectly
our late-stage internal pipeline and our Focused In-
novator ambition to build a neuro-rare franchise and
reestablish Lundbeck’s strong presence in the epi-
lepsy space.
There is a strong unmet need across a broad range
of epilepsy indications, including Developmental and
Epileptic Encephalopathies (DEEs). Among the more
than 20 known DEEs, only 4 have approved treat-
ments so far. The innovative potential of bexicaserin,
with its unique 5-HT
2C
super-agonist mechanism of
action, positions us to address significant unmet
needs in severe epilepsies across DEEs including
Dravet and Lennox-Gastaut syndromes.
Bexicaserin has the potential to address all DEEs,
and compared to the treatments currently available,
e.g., fenfluramine, bexicaserin has greater selectivity
and specificity, designed to only bind 5-HT
2C
recep-
tors. On 30 January 2025, Lundbeck announced the
headline results of the bexicaserin PACIFIC phase
1b/2a 12 months Open-Label-Extension study evalu-
ating bexicaserin in patients with Developmental
and Epileptic Encephalopathies (DEEs) demonstrat-
ing a sustained, durable response in seizure reduc-
tion and a favorable safety and tolerability profile
across a broad range of DEE patients. These data
provide further support to bexicaserin’s potential to
offer a highly differentiated and best-in-class profile.
Hormonal / neuropeptide signaling
Lu AG09222 – phase II
Lu AG09222 represents a potential new therapeutic
option for the treatment of migraine, which, unlike
the calcitonin gene-related peptide (CGRP) migraine
treatment drug class, is a monoclonal antibody tar-
geting pituitary adenylate cyclase-activating poly-
peptide (PACAP). PACAP and its receptors are
broadly expressed in the nervous systems and in-
flammatory cells. By interfering with the PACAP sig-
naling, there is a potential to affect multiple symp-
toms of headache disorders.
Lundbeck has initiated the PROCEED trial, a phase IIb
trial with subcutaneously administered Lu AG09222
that builds on the positive results of the HOPE trial.
PROCEED is an interventional, randomized, double-
blind, parallel-group, placebo-controlled, dose-find-
ing phase IIb trial that will be conducted in Europe,
Japan and the U.S. It assesses 4 different doses of Lu
AG09222 versus placebo, administered subcutane-
ously once monthly for three months. The trial is in-
tended to establish the optimal dose for future
global pivotal trials designed to confirm the efficacy
and safety of Lu AG09222 as a migraine preventive
treatment. PROCEED is planned to enroll approxi-
mately 498 patients and will assess the efficacy,
safety and tolerability of Lu AG09222.