Alder builds case for CGRP migraine drug eptinezumab

Migraine headache/epilepsy brain image
Competition in the migraine prevention market is expected to be fierce. (CC0 Creative Commons)

Alder BioPharma has reported new data from its phase 3 trial of CGRP inhibitor eptinezumab in episodic migraine, adding to evidence backing the drug as it prepares for what looks set to be a fierce commercial battle.

Updated results from the PROMISE-1 trial, reported at the American Academy of Neurology (AAN) annual meeting in Los Angeles this week, showed that a single intravenous dose of eptinezumab was able to reduce the number of migraine days in patients significantly compared to placebo over a three-month period, and gave patients more pain-free days in between.

Almost 30% of patients receiving a 300mg dose of the antibody had a 75% reduction in monthly migraine days from their baseline level of 8.6 days per month, compared to 16% of the placebo group.

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The biotech is planning to file for approval of eptinezumab in episodic and chronic migraine before the end of the year, but is facing some heavyweight competition from deep-pocketed rivals including Eli Lilly, Amgen/Novartis and Teva. It needs to differentiate its drug if it is to make headway in a market that analysts suggest could be worth up to $5 billion at peak.

Alder says eptinezumab stands out from the competition because it is given by infusion every three months, while Lilly’s galcanezumab, Amgen/Novartis’ erenumab and Teva’s fremanezumab—which have all been filed with the FDA with reviews due to complete in the next few months—are administered via subcutaneous injection either once a month or also quarterly in the case of fremanezumab.

The IV route of administration means that eptinezumab has a rapid onset of action, providing relief to some patients within a day. Alder’s former CEO and co-founder Randy Schatzman, Ph.D., who abruptly left the company earlier this year, previously said that subcutaneous drugs may take “weeks, or even a month” to take effect.

For Alder’s VP of neurology R&D Roger K. Cady, M.D., the time between migraine days is also a critical feature of eptinezumab, as patients’ quality of life “is limited by the fear of a potential migraine, which severely impacts their activities of daily living, family life and careers.”

The data showed that in the patient group with a 75% or greater response, the interval between migraines lengthened from an average of just under four days to more than a month.

He adds that the “significant periods of freedom from migraine delivered in the trial represents a compelling attribute of eptinezumab’s clinical profile.”

The antibody-based CGRP drugs could soon be joined by orally-active GCGRP drugs or "gepants" for acute migraine—currently headed by Allergan’s ubrogepant which has just passed a phase 3 test and could be filed next year and Biohaven’s late-stage candidate rimegepant.