Lilly's CGRP Antibody Galcanezumab Shows Positive Phase 3 Results in Preventive Migraine Treatment

By | Pharma Insights

On September 6, Eli Lilly and Company (China) announced that Emgality (galcanezumab), a medication for the preventive treatment of migraine, achieved positive primary results in a global, multicenter Phase 3 clinical study predominantly enrolling Chinese patients. Analysis of the study demonstrated that the galcanezumab treatment group was significantly superior to the placebo group at the primary endpoint and all four key secondary endpoints.

CGRP stands for calcitonin gene-related peptide. In the 1990s, scientists first discovered that CGRP levels in patients' blood increase during migraine attacks, and that CGRP released by the trigeminal nervous system acts as the "switch" that triggers migraine onset. This discovery has established the CGRP signaling pathway as a prominent therapeutic target for migraine treatment.

Galcanezumab is a humanized CGRP monoclonal antibody that binds to CGRP, thereby blocking the binding of CGRP to its receptor, which is expected to alleviate and improve headache symptoms. The drug has been approved by the US FDA for the preventive treatment of migraine in adults and for the treatment of adult patients with episodic cluster headache.

The CGAX study, which reported positive results, was a prospective, global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study enrolling a predominantly Chinese patient population. The study aimed to evaluate the efficacy and safety of galcanezumab for the preventive treatment of episodic migraine in adults. The primary endpoint was monthly headache days (MHD). The four key secondary endpoints included the MSQ score (quality of life score), the 50% responder rate (proportion of patients achieving a ≥50% reduction in headache days from baseline), the 75% responder rate, and the 100% responder rate.

Results from the CGAX study demonstrated that: for the primary endpoint of monthly headache days, the galcanezumab treatment group was significantly superior to the placebo group; regarding the four key secondary endpoints assessing the functional impact of migraine, the treatment group also demonstrated superiority over the placebo group, consistent with the findings from previously completed global pivotal studies. Additionally, galcanezumab exhibited a favorable safety profile, with the majority of adverse events being mild to moderate in severity, and no serious adverse events or deaths were reported.

It is worth noting that in March 2021, Eli Lilly China announced that lasmiditan, another drug from the company for the acute treatment of migraine in adults, also yielded positive results in the Chinese extension enrollment of the global Phase 3 clinical trial. Lasmiditan is an innovative oral serotonin (5-HT) 1F receptor agonist approved by the FDA for the acute treatment of migraine with or without aura in adults.

Migraine is a disabling neurological disorder characterized by recurrent episodes of severe headache. Associated symptoms include nausea, vomiting, photophobia, phonophobia, and visual disturbances, which severely impact patients' quality of life. We hope that the subsequent clinical development of Eli Lilly and Company's novel migraine medication proceeds smoothly, leading to timely regulatory approval in China and providing patients with a new treatment option.

References:

[1] Positive Primary Results from Phase 3 Clinical Trial of Emgality® (galcanezumab) for the Preventive Treatment of Migraine. Retrieved Sep 06, 2021, from https://mp.weixin.qq.com/s/_XhlhZ1xvfdcR45PlKHh2Q

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