Lilly plans 2018 filing for acute migraine drug after second phase 3 win

SPARTAN results match earlier positive SAMURAI trial

Eli Lilly's bid to bring a new class of migraine therapy to market has just been lifted by a second positive trial that sets up first-marketing applications next year.

The top-line results of the SPARTAN trial show that oral serotonin 5-HT1F agonist lasmiditan provided relief from the headache pain and other symptoms associated with acute migraine attack, such as nausea and aversion to light or loud sounds, in as little as two hours, matching the results of its earlier SAMURAI study.

With a dose of 50mg, 28.6% of patients were headache-free at two hours, rising to 31.4% at the 100mg dose and 38.8% of those on 200mg. The placebo response rate was 21.3%. Upwards of 40% of patients in all three dose groups were also free of their most bothersome symptom other than headache, compared to a third (33.5%) of the placebo group.

FREE DAILY NEWSLETTER

Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

While expected, the outcome of the trial is a relief to Lilly which forked out nearly $1 billion in January to buy out lasmiditan developer CoLucid Pharmaceuticals, claiming back the drug which it discovered and licensed out to CoLucid in 2005.

If approved lasmiditan would be a good pairing for Lilly's other big migraine hope galcanezumab, a CGRP inhibitor which, rather than treating acute attacks, works as a maintenance therapy to try to stop them occurring in the first place. Lilly is competing with rivals Teva and Alder Biopharma to bring the first CGRP inhibitor to market.

"Lasmiditan represents the first significant innovation in the acute treatment of migraine in more than 20 years," said Christi Shaw, president of Lilly Bio-Medicines. The first-in-class drug could provide a much-needed new treatment option for the 36 million Americans living with migraine, she added.

For years, migraine attacks were thought to be caused by the dilation of blood vessels in the brain, and since the 1990s acute treatment has relied on painkillers and another class of serotonin-acting drugs, the 5-HT1B/1D agonists or triptans, now available as generics, which cause the blood vessels to constrict.

Lasmiditan turns that idea on its head because it treats migraine without constricting blood vessels, which means it isn't contraindicated in the approximately one-third of migraine sufferers who can’t take triptans because of heart problems and also avoids side effects such as chest constriction and throat tightness. Its mechanism isn't clear but could also involve an interaction with the CGRP pathway.

The most commonly reported adverse events after lasmiditan dosing were dizziness, numbness, somnolence, fatigue, nausea and lethargy, according to Lilly.

Lasmiditan's safety profile could offer an important advantage over triptans, but the challenge for Lilly will be to price the drug at a level that doesn't impede take-up of the drug—given that triptans cost a few hundred dollars per patient per year.

It's worth noting however that a sizeable proportion of migraine patients—perhaps up to a third—don't respond to triptans, and some studies have suggested nearly two-thirds of users have problems with them, either due to a lack of efficacy or tolerability issues. That could drive demand for lasmiditan and, according to Barclays analysts, could make it a $700 million product based on an estimated price of around $1,750 per year before discounts.