Lundbeck's Migraine Drug Hits Roadblock in Phase III

Copenhagen-based Lundbeck revealed Wednesday that its migraine drug Vyepti (eptinezumab) failed to demonstrate statistical superiority over placebo at reducing the number of monthly migraine days.

Though Vyepti earned FDA approval in 2020 as a preventive measure against migraine in adults, the drug was put through a small Phase III trial called Sunlight, which Lundbeck hoped would pave an accelerated path to approval for the drug in China.

Sunlight is a randomized, double-blinded and parallel-group study that compared Vyepti against placebo in nearly 200 patients. To be eligible, participants had to have been clinically diagnosed with migraine and medication overuse headache (MOH). The trial was initiated in 2021, in line with Lundbeck’s goal of supporting Vyepti’s registration in Asia. More than half of its 40 study sites are in China, and fewer than ten are located outside Asia.

Sunlight’s primary outcome of interest was a reduction in monthly migraine days from baseline. While Vyepti was able to slightly outperform placebo, its effects ultimately fell short of statistical significance. This was true, too, for key secondary endpoints. The company revealed these findings in its quarterly financial report.

While more data from Sunlight are expected to roll in in the coming months, Lundbeck will now most likely have to fall back on its second Vyepti trial, Sunrise. Unlike Sunlight, Sunrise will not restrict eligibility to those with MOH; a clinical diagnosis of migraine is enough. It is a much larger study, too, enrolling more than 500 patients across more study sites. Aside from locations in China, Sunrise is also recruiting patients from Japan, Korea, Taiwan, Georgia and Spain. 

Lundbeck also continues to explore new indications for Vyepti, even beyond Asia. This year alone, the company has initiated two trials for the drug. The first is an explorative, randomized, real-world and pragmatic study comparing Vyepti against other preventive treatments in adults with episodic or chronic migraine. The other, named Resolution, is a Phase IV study looking at the preventive impact of Vyepti combined with a short educational intervention in patients with migraine and MOH.

Vyepti is a migraine medicine that works by blocking the protein called calcitonin, a gene-related peptide. Unlike other big anti-CGRPs in the market, Lundbeck’s drug is given as an infusion and thus can act much faster than oral competitors. Vyepti reaches 100% bioavailability within half an hour of administration, according to Lundbeck. 

This fast-relief action has helped Vypeti carve out a nice niche for itself, particularly among patients with more severe migraines. In the first half of 2022 alone, drug sales soared 120% compared with the same period the year before, netting the company over $50 million.

But competition in the migraine space is stiff. Biohaven’s oral migraine treatment Nurtec ODT (Rimegepant) earned the company more than $190 million just in the second quarter of this year, up 57% from the first quarter. The drug is so promising that in May this year, pharma powerhouse Pfizer bought it out in an $11.6-billion deal. The Connecticut-based also company has other migraine drugs in the works, including the nasal spray zavegepant.