Successful Phase III ARISE study of AMG 334 (erenumab) in episodic migraine prevention.Novartis

Novartis has announced positive topline results from ARISE, the first Phase III study evaluating the efficacy and safety of monthly subcutaneous AMG 334 (erenumab) 70mg in episodic migraine prevention. The study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients treated with AMG 334 compared with placebo at 12 weeks. AMG 334 is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor that is believed to have a critical role in mediating the incapacitating pain of migraine.

A total of 577 patients enrolled in ARISE were randomized to receive either placebo or AMG 334 at 70mg subcutaneously, once monthly. Patients experienced between four and 14 migraine days each month, with an average of eight migraine days per month at baseline.Those receiving AMG 334 experienced a statistically significant 2.9-day reduction from baseline in monthly migraine days, as compared to a 1.8-day reduction in the placebo arm. The safety profile of AMG 334 was similar to placebo and consistent with previously-reported studies. The most common adverse events were upper respiratory tract infection, injection site pain, and nasopharyngitis. Further analysis of the ARISE data is ongoing, and will be submitted to a future medical meeting and for publication. The STRIVE study, a second Phase III episodic migraine study evaluating both 70mg and 140mg doses of AMG 334 for 24 weeks, is expected to be completed by the end of this year. Positive results from a Phase II study of AMG 334 in chronic migraine prevention were also announced earlier this year.