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 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.
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 medical need for additional safe and effective migraine prophylactic medications. High frequency episodic migraine shares many similarities with chronic migraine. Patients with this condition are at a high risk of transformation to chronic migraine, and have similar unmet needs due to a paucity of currently approved preventive medications. These preventive medications require daily use, are not effective in a large percentage of patients, and are commonly associated with adverse events.
About Labrys Biologics
Labrys Biologics is a private, venture-financed development stage biotechnology company focused on the preventive treatment of migraine. Labrys' lead candidate, LBR-101 (formerly RN-307), is an anti-CGRP monoclonal antibody for the prevention of chronic and high frequency migraine currently in Phase 2b clinical development. In 2013, Labrys raised a Series A of $31 million backed by venBio, Canaan Partners, InterWest Partners and Sofinnova Ventures. More information is available at www.labrysbiologics.com.
SOURCE Labrys Biologics Inc.