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 About 38 million Americans suffer from migraines - intense headaches
characterized by throbbing pain, sensitivity to light and nausea.
The condition, in which attacks can last for days, is not curable.
Multiple doses of the drug, ALD403, were tested against a placebo in
patients suffering from chronic migraines, those who experienced 15
or more headache days per month, of which at least eight were
assessed as migraine days.
The two highest doses of the drug, 300 mg and 100 mg, brought about
a 75 percent reduction in migraine days in 33 percent and 31 percent
of patients respectively, meeting the main goal of the study.
Drugs taken to treat migraines don't always work, while the
side-effects of preventative medicines typically approved for other
conditions, including beta blockers and botox, discourage their use.
Prophylactic treatments lower headache frequency by about half in
the 40 percent of sufferers who use them, the American Migraine
Foundation estimates.
Alder joins companies such as Amgen Inc, Eli Lilly Co and Teva
Pharmaceutical Industries Ltd that are developing similar drugs to
target calcitonin gene-related peptide, or CGRP, a protein involved
in pain-signaling during migraines.
Alder's data addresses outstanding questions about the drug's
competitiveness on dosing and administration, indicating the
antibody should be as good if not better than others in development,
Jefferies analysts wrote in a note.
The drug is differentiated by how fast it acts and the durability of
its effect, Chief Executive Randall Schatzman told Reuters in an
interview.
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"We're proposing that patients are dosed four times a year. Most
other developers are looking at once-a-month dosing," he said,
adding that separate early-stage data also showed the treatment
could potentially be self-administered.
The drug is currently in a late-stage trial for use in frequent
episodic migraine. A late-stage study for chronic migraine sufferers
is slated to begin later this year.
If all goes well, ALD403 could win U.S. Food and Drug Administration
approval by 2019, said Schatzman. Alder plans to independently sell
the medicine in the United States to serve the 13 million patients
eligible for migraine prevention therapy.
The Bothell, Washington-based company's stock was up about 30
percent in premarket trade.
(Reporting by Natalie Grover in Bengaluru; Editing by Anupama
Dwivedi)
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