No deaths or treatment-related serious BMN 673 adverse events (AEs) were reported, and no subjects discontinued because of AEs. The authors concluded that BMS-927711 is superior to placebo at several different doses (75 mg, 150 mg, and 300 mg) and has an excellent tolerability profile. The company has not announced any future development plans for BMS-927711, and the drug no longer appears as a pipeline product on the corporate website, as of late 2013. Arteaus Therapeutics,
LLC, licensed worldwide development rights in 2011 from Eli Lilly and Co. to a humanized monoclonal antibody that potently and selectively binds to CGRP. LY2951742 has completed Phase 1 clinical testing in 56 subjects (NCT01337596). Although the preliminary results reportedly demonstrated that the antibody appeared to be well tolerated, the final results from the study are not expected to be presented until early in 2014. A Phase 2 study entitled “A Study of LY2951742 in Patients With Migraine” (NCT01625988) was initiated at 21 sites in the United States in June 2012. The planned enrollment for the study was 190 subjects, and the study had completed enrollment buy GDC-0068 of subjects as of late 2013. The objective of the study was to assess the efficacy and safety of LY2951742 in the prevention of migraine headache during 3 months of treatment in subjects with a “moderate
frequency of migraine headaches.” The antibody was administered as a subcutaneous injection once every other week.
Results from this study are expected to be available early in 2014. These data should therefore represent the first available efficacy data from the use of CGRP antibodies in the treatment of migraine. AMG 334 (from Amgen) is a fully human monoclonal antibody that is selective for the CGRP receptor complex. In theory, the ability to block the CGRP receptor (as opposed to CGRP itself) might be advantageous because binding to the CGRP receptor might prevent receptor activation, independent of CGRP release. NADPH-cytochrome-c2 reductase An initial Phase 1 study of 68 subjects entitled “Ascending Single Doses of AMG 334 in Healthy Subjects and Migraine Patients” (NCT01688739) was completed in mid-2013, but the results have yet to be reported. A second Phase 1 study of 40 subjects entitled “Ascending Multiple-Doses of AMG 334 in Healthy Subjects and in Migraine Patients” (NCT01723514) was started in late 2012 and is scheduled to complete in late 2013. A Phase 2 Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention” (NCT01952574) was initiated in late 2013. It has a planned enrollment of 468 subjects at 39 study sites. It is likely that some of these data would be available in late 2014. In addition, AMG 334 is also being studied in a Phase 1 trial in women with hot flashes associated with menopause (NCT01890109).
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