Post hoc analyses of Phase III studies of galcanezumab shows 50% reduction of migraine headache days.- Eli Lilly.

Eli Lilly and Company announced results from a post-hoc subgroup analysis which demonstrated efficacy of galcanezumab in patients with episodic and chronic migraine who previously failed to respond to two or more preventive therapies. Detailed results from a new subgroup analysis of three Phase III studies (EVOLVE-1, EVOLVE-2 and REGAIN) evaluating galcanezumab will be presented as part of the "Best of Headache" platform session at the American Academy of Neurology (AAN) annual meeting in Los Angeles.

As previously reported, in these Phase III studies, the most commonly-reported adverse events were injection site reactions.

In this subgroup analysis, patients treated with both doses of galcanezumab who previously failed two or more preventive therapies experienced a statistically significant reduction in the average number of monthly migraine headache days, and at least a 50 percent reduction in the number of migraine headache days, compared to patients treated with placebo. EVOLVE-1/ EVOLVE-2 (as evaluated over six months) for patients who failed at least 2 prior preventive medications (N=172): Average reduction in monthly migraine headache days: 3.45 days for 120 mg and 3.85 days for 240 mg compared to 0.81 days for placebo, p<0.001 for both dosing groups compared with placebo. mean percentages of patients with at least 50 percent reduction in monthly migraine headache days: 54.6 for 120 mg and 61.2 for 240 mg compared to 26.2 for placebo p><0.001 for both dosing groups compared with placebo. regain as evaluated over three months for patients who failed at least 2 prior preventive medications n="323):" average reduction in monthly migraine headache days: 5.91 days for 120 mg and 3.30 days for 240 mg compared to 1.44 days for placebo p><0.01 for both dosing groups compared with placebo. mean percentages of patients with at least 50 percent reduction in monthly migraine headache days: 30.4 for 120 mg and 18.3 for 240 mg compared to 9.7 for placebo p><0.05 for both dosing groups compared with placebo.>

Comment: Galcanezumab represents the first of three investigational, non-opioid treatments in development as part of Lilly's overall pain portfolio. The portfolio also includes lasmiditan for the acute treatment of migraine and tanezumab, developed in partnership with Pfizer, for the treatment of osteoarthritis pain, chronic low back pain and cancer pain. Lilly also is evaluating galcanezumab for the treatment of cluster headache with Phase III trial results expected in the second quarter of 2018..