Targeting Pituitary Adenylate Cyclase-Activating Polypeptide with Lu AG09222 Antibody to Prevent Migraine
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Reviewed & Translated by Dat Tien Nguyen, B.A, ScM.
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Posted on October 18th, 2024
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Migraine is a prevalent condition that can severely impact an individual's quality of life. Preventative treatments like propranolol and topiramate have often proven either ineffective or associated with significant side effects. Previous research has demonstrated that pituitary adenylate cyclase-activating polypeptide (PACAP) can induce migraine attacks in patients. Consequently, a study was conducted in Denmark, with funding from the pharmaceutical company Lundbeck, to explore the potential of Lu AG09222, a PACAP-targeting antibody, as a treatment for managing migraines.
The phase 2 clinical trial involved 237 participants diagnosed with migraine according to the International Classification of Headache Disorders, 3rd Edition. Of the participants, 68% had chronic migraine, while the remaining had episodic migraine. The participants had an average of 16.7 migraine days in the previous month, with an average cranial autonomic parasympathetic symptom score of 0.9. The patients were randomly assigned to receive an intravenous dose of either a placebo or Lu AG09222 at two different levels: 750 mg or 100 mg. Four weeks after treatment, the 750 mg dose of Lu AG09222 was shown to significantly reduce the number of migraine days by 2. At the 12-week safety assessment, the higher 750 mg dose was linked to a greater frequency of adverse events. The authors suggested that future phase 3 studies should include more participants and extend the treatment and observation periods.
The phase 2 clinical trial involved 237 participants diagnosed with migraine according to the International Classification of Headache Disorders, 3rd Edition. Of the participants, 68% had chronic migraine, while the remaining had episodic migraine. The participants had an average of 16.7 migraine days in the previous month, with an average cranial autonomic parasympathetic symptom score of 0.9. The patients were randomly assigned to receive an intravenous dose of either a placebo or Lu AG09222 at two different levels: 750 mg or 100 mg. Four weeks after treatment, the 750 mg dose of Lu AG09222 was shown to significantly reduce the number of migraine days by 2. At the 12-week safety assessment, the higher 750 mg dose was linked to a greater frequency of adverse events. The authors suggested that future phase 3 studies should include more participants and extend the treatment and observation periods.