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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

mean change from baseline in the number of migraine days after 12 weeks of treatment. Topline data are expected in late 2014 to early 2015.

About LBR-101
LBR-101 (formerly RN-307) is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a well validated target in migraine. LBR-101 was originally discovered and developed by Rinat Pharmaceuticals, which was acquired by Pfizer in 2006.  LBR-101 has successfully completed Phase 1 trials with active drug being given to 106 volunteers, results of which were published in Cephalalgia, the official journal of the International Headache Society, in December 2013. Both IV and subcutaneous administrations were extremely well tolerated. LBR-101 exhibited a long terminal half-life ranging from 40 to 48 days, which supports once-monthly dosing. Most treatment related adverse events were mild, transient and resolved spontaneously. The most common TEAEs reported were nasopharyngitis, gastroenteritis and back pain. A maximum tolerated dose has not been identified. LBR-101 was not associated with any clinically relevant patterns of change in vital signs, ECG parameters, or laboratory findings.

LBR-101's long half-life, target specificity and favorable pharmacokinetic profiles, including lack of hepatic metabolism and limited potential for drug interaction may address substantial unmet needs for the prevention of frequent episodic migraines and chronic migraines, a market estimated to be more than 10 million patients in the United States. Proof of efficacy was obtained for several CGRP antagonists in the symptomatic (acute) relief of migraine, yet prophylactic use of those small molecules has been limited by liver toxicity or formulation difficulties. There is only one FDA approved drug for the prevention of chronic migraine (onabotulinumtoxin A), demonstrating the significant
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SOURCE Labrys Biologics Inc.
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