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.
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.