Eli Lilly presented a post hoc analysis of its monthly migraine therapy galcanezumab, one of a new class of targeted preventive drugs, as it looks to show the drug's effectiveness after the failure of other treatments.
Currently under review at the FDA, galcanezumab may enter a potentially crowded field of monoclonal antibody (mAb) treatments designed to stop the calcitonin gene-related peptide (CGRP) believed to play a major role in migraines and cluster headaches.
Drugs with similar mechanisms of action have already been submitted to the agency, including Amgen and Novartis’ erenumab (Aimovig, with PDUFA on May 17) and Teva’s fremanezumab (PDUFA in June, although manufacturing issues may delay any launch until next year), while smaller biotech Alder expects to file an application for its eptinezumab infusion later in the year. Lilly, meanwhile, expects the FDA’s decision on galcanezumab in the third quarter.
Last May, Teva said the phase 3 Halo study of fremanezumab hit its endpoints. During the 12-week period after first dose, patients treated with the med saw statistically significant reduction in monthly moderate-or-above headache days for both monthly (-4.6 days) and quarterly (-4.3 days) dosing regimens, compared to a dummy treatment's 2.5-day improvement.
Those on fremanezumab also saw a "significant improvement" compared to placebo on all secondary endpoints for both monthly and quarterly dosing regimens, including response rate, onset of efficacy, efficacy as monotherapy, and disability.
And Aimovig also hit positive notes back in January, meeting its primary and secondary endpoints in a phase 3b study involving migraine patients where other therapies have not worked. In the test, more patients on Aimovig experienced 50% fewer monthly migraine days than baseline when compared to a dummy therapy.
It also hit its secondary endpoints, including reduction of monthly migraine days, reduction in days needing rescue medication and improved scores on the Migraine Physical Function Impact Diary (MPFID) tool.
Credit Suisse analysts recently pegged the market for migraine prevention at $5 billion, and migraine treatment could add significantly to that, with all these companies vying for market share.
To help stand out in the crowd, Lilly’s subgroup analysis, presented today at the annual meeting of the American Academy of Neurology (AAN), shows patients receiving 120mg and 240mg injections of galcanezumab had average reductions of 3 to 5 migraine headache days each month following the failure of two or more preventive therapies.
“In fact, if you look at the difference versus placebo, it’s actually greater in the subjects that have failed two preventives, compared to those that did not,” said Eric Pearlman, a medical fellow for Lilly’s migraine portfolio, who spoke to FierceBiotech ahead of the AAN data presentation.
Meanwhile, more than half of patients that should be considered for preventive migraine medication are not receiving them, Pearlman said. “There’s a tremendous need for innovative treatment options for patients suffering from episodic and chronic migraine.”
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Many stop taking preventive therapies due to side effects or lack of efficacy, said Christi Shaw, president of Lilly Bio-Medicines. “Past research has shown nearly half of patients with migraine discontinue a newly-prescribed preventive therapy within 60 days of prescription, regardless of drug class,” she explained.
“The clinicians feel like Lilly is new to the migraine space, but Lilly has been investigating treatments for migraine for over 25 years,” Pearlman said, describing migraine as a ‘prioritized therapeutic’ area for the company.
Self-administered monthly using an auto-injector or prefilled syringe similar to other Lilly products, galcanezumab went through its clinical trials lasting three to six months, with 90% patients completed it, he said.
“One of the things that we hear when we talk to migraine patients is they’re not interested in being reminded every day that they have migraines impacting their ability to function,” by taking daily pills or injections, said Pearlman. Once-monthly erenumab and once-quarterly fremanezumab are similar in that respect as well.
But Lilly also is looking at galcanezumab for the treatment of cluster headaches, with two of the largest phase 3 studies ever performed in the indication due to deliver their results before July, in what it hopes will really help it stand out from the crowd.
“Regardless of their outcomes, they will contribute greatly to the headache community’s understanding of this severely incapacitating disease,” said Pearlman.