SAN MATEO, CA, USA I June 26, 2013 I Labrys Biologics Inc., a biotechnology company focused on treatments for chronic migraine, today announced data from three late-breaking poster presentations demonstrating the pharmacokinetics and safety profile of LBR-101 (formerly RN-307) observed in multiple Phase 1 clinical studies. LBR-101 is a humanized monoclonal antibody that blocks the binding of CGRP to its receptor and is in development for the prevention of chronic migraine. Data will be presented at the 2013 International Headache Congress taking place June 27-30, 2013 in Boston.
In summary:
- Based upon pooled data from four separate Phase 1 studies, single doses of LBR-101 ranging from 0.2 mg to 2000 mg IV and two doses up to 300 mg IV administered once every 14 days are extremely well tolerated
- LBR-101 exhibited a long terminal half-life ranging from 39 to 48 days, which should enable monthly dosing
- Most treatment related adverse events were mild, transient and resolved spontaneously
- A maximum tolerated dose has not been identified
“The Phase 1 studies of LBR-101 demonstrate encouraging tolerability and a good pharmacokinetic profile,” said Marcelo Bigal, M.D., Ph.D., Chief Medical Officer at Labrys Biologics. “The half-life of 45 days is optimal for monthly dosing in future Phase 2 studies evaluating LBR-101 for the prevention of chronic migraine.”
In a pooled analysis, five separate Phase 1 clinical studies investigated various single and multiple dose levels of LBR-101 in healthy volunteers. All Phase 1 studies were randomized, placebo-controlled, double-blind within a dose cohort. A total of 94 subjects received the active drug.
Calcitonin gene-related peptide (CGRP) has been connected to the biology of migraine at multiple levels. CGRP release causes vasodilation and inflammation on blood vessels that are of importance to migraine, as well as poor modulation of sensory transmission in the brain. Proof of efficacy of CGRP receptor antagonists has been demonstrated in the clinical relief of migraine. However, signs of liver toxicity when these small molecules are used frequently seem to impose a barrier for their use as preventive treatment. CGRP monoclonal antibodies such as LBR-101 are promising therapies for migraine prophylaxis due to their targeted approach, prolonged circulating half-life, and reduced potential for liver toxicity.
LBR-101 posters from the 2013 International Headache Congress will be available at Labrys‘ website at www.LabrysBiologics.com.
About Chronic Migraine
Chronic migraine, defined as fifteen or more headache days per month, is a serious and widespread condition that affects several million people, or approximately 1.0% of the U.S. population. Chronic migraineurs suffer from debilitating headaches frequently accompanied by nausea, vomiting, sensitivity to light and fatigue, and they often report periods of lost productivity. There is a significant need for chronic migraine therapies with better efficacy and improved safety.
About LBR-101
LBR-101 (formerly RN-307) is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a validated target in migraine. LBR-101 has successfully completed Phase 1 trials with active drug being given to 94 volunteers. LBR-101 was originally discovered and developed by Rinat Pharmaceuticals, which was acquired by Pfizer in 2006.
About Labrys Biologics
Labrys Biologics is a private, venture-financed development stage biotechnology company focused on treatments for chronic migraine. Labrys‘ lead candidate, LBR-101 (formerly RN-307), is an anti-CGRP monoclonal antibody for the treatment of chronic migraine which has completed Phase 1. Founded in late 2012, Labrys is backed by venBio, Canaan Partners, InterWest Partners and Sofinnova Ventures.
SOURCE: Labrys Biologics
Post Views: 150
SAN MATEO, CA, USA I June 26, 2013 I Labrys Biologics Inc., a biotechnology company focused on treatments for chronic migraine, today announced data from three late-breaking poster presentations demonstrating the pharmacokinetics and safety profile of LBR-101 (formerly RN-307) observed in multiple Phase 1 clinical studies. LBR-101 is a humanized monoclonal antibody that blocks the binding of CGRP to its receptor and is in development for the prevention of chronic migraine. Data will be presented at the 2013 International Headache Congress taking place June 27-30, 2013 in Boston.
In summary:
- Based upon pooled data from four separate Phase 1 studies, single doses of LBR-101 ranging from 0.2 mg to 2000 mg IV and two doses up to 300 mg IV administered once every 14 days are extremely well tolerated
- LBR-101 exhibited a long terminal half-life ranging from 39 to 48 days, which should enable monthly dosing
- Most treatment related adverse events were mild, transient and resolved spontaneously
- A maximum tolerated dose has not been identified
“The Phase 1 studies of LBR-101 demonstrate encouraging tolerability and a good pharmacokinetic profile,” said Marcelo Bigal, M.D., Ph.D., Chief Medical Officer at Labrys Biologics. “The half-life of 45 days is optimal for monthly dosing in future Phase 2 studies evaluating LBR-101 for the prevention of chronic migraine.”
In a pooled analysis, five separate Phase 1 clinical studies investigated various single and multiple dose levels of LBR-101 in healthy volunteers. All Phase 1 studies were randomized, placebo-controlled, double-blind within a dose cohort. A total of 94 subjects received the active drug.
Calcitonin gene-related peptide (CGRP) has been connected to the biology of migraine at multiple levels. CGRP release causes vasodilation and inflammation on blood vessels that are of importance to migraine, as well as poor modulation of sensory transmission in the brain. Proof of efficacy of CGRP receptor antagonists has been demonstrated in the clinical relief of migraine. However, signs of liver toxicity when these small molecules are used frequently seem to impose a barrier for their use as preventive treatment. CGRP monoclonal antibodies such as LBR-101 are promising therapies for migraine prophylaxis due to their targeted approach, prolonged circulating half-life, and reduced potential for liver toxicity.
LBR-101 posters from the 2013 International Headache Congress will be available at Labrys‘ website at www.LabrysBiologics.com.
About Chronic Migraine
Chronic migraine, defined as fifteen or more headache days per month, is a serious and widespread condition that affects several million people, or approximately 1.0% of the U.S. population. Chronic migraineurs suffer from debilitating headaches frequently accompanied by nausea, vomiting, sensitivity to light and fatigue, and they often report periods of lost productivity. There is a significant need for chronic migraine therapies with better efficacy and improved safety.
About LBR-101
LBR-101 (formerly RN-307) is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a validated target in migraine. LBR-101 has successfully completed Phase 1 trials with active drug being given to 94 volunteers. LBR-101 was originally discovered and developed by Rinat Pharmaceuticals, which was acquired by Pfizer in 2006.
About Labrys Biologics
Labrys Biologics is a private, venture-financed development stage biotechnology company focused on treatments for chronic migraine. Labrys‘ lead candidate, LBR-101 (formerly RN-307), is an anti-CGRP monoclonal antibody for the treatment of chronic migraine which has completed Phase 1. Founded in late 2012, Labrys is backed by venBio, Canaan Partners, InterWest Partners and Sofinnova Ventures.
SOURCE: Labrys Biologics
Post Views: 150
