Alder Biopharmaceuticals has dosed the first patients in proof-of-concept Phase II study evaluating the safety and efficacy of ALD403, administered monthly for the treatment of migrane.
ALD403 is an antibody therapeutic candidate being developed to target calcitonin gene-related peptide (CGRP), to treat migraine.
The Montefiore Headache Center director, Albert Einstein College of Medicine professor of neurology and epidemiology and principal investigator Dr Richard Lipton said most of the currently available preventive migraine treatments are administered on a daily basis, reduce migraine frequency by 50% in only half of users and can have signifant side effects.
"A biologic targeting CGRP and offering higher rates of efficacy, along with less frequent dosing and fewer side effects, could have a tremendous benefit for patients," Lipton said.
A total of 160 patients with frequent, episodic migraines are expected to be enrolled in the double-blind, placebo-controlled study across six sites for a period of six months.
Study particpants experienced between four and 14 migraines each month for least three months before enrolment, and take acute migraine medication.
Alder Biopharmaceuticals president and chief executive officer Dr Randall Schatzman said; "The preventative approach has been welcomed by patients, evidenced by the significant patient interest at all of our trial sites, and we are proud to advance ALD403 into a proof-of-concept trial while exploring additional applications for our core technologies with therapeutic candidates in other disease areas."