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Labrys Biologics Initiates Two Phase 2 Studies of LBR-101 for the Prevention of Chronic and Episodic Migraine
Date:1/8/2014

SAN MATEO, Calif., Jan. 8, 2014 /PRNewswire/ -- Labrys Biologics Inc., a biotechnology company focused on treatments for migraine, today announced that patients are now being enrolled in two separate Phase 2b clinical studies of LBR-101 (formerly RN-307) as a subcutaneous once-monthly treatment for the prevention of frequent migraines. The first study is enrolling subjects with chronic migraine, who experience at least 15 headache days per month. The second study is enrolling subjects with high frequency episodic migraine, who experience headaches eight to 14 days per month. 

"Clinical data from six previous clinical studies of LBR-101, as well as emerging evidence of the potential role of anti-CGRP antibodies in the treatment of migraine, supports the expansion of our clinical program to include prevention of high frequency episodic migraine in addition to chronic migraine," said Steven P. James, president and CEO of Labrys Biologics. "Based on results from a recently completed Phase 1 study assessing the subcutaneous delivery of LBR-101, we will be investigating the once-monthly subcutaneous delivery of LBR-101 in both Phase 2 studies, which if successful, should make the product considerably more attractive in medical practice and to patients."

Both studies are multicenter, randomized, double-blind, placebo-controlled, parallel group, multi-dose studies. Approximately 225 and 270 patients are expected to complete the chronic migraine and high frequency episodic migraine studies, respectively.  Subjects will be randomized to receive placebo, a low dose or a high dose treatment once per month for three months. Primary efficacy endpoint for the chronic migraine trial captures the mean change from baseline in the number of hours with headache on the final month of the study (after 12 weeks of treatment). For the high frequency episodic migraine study, the primary endpoint measures the
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SOURCE Labrys Biologics Inc.
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