Eli Lilly and Company announced results from a post-hoc analysis which demonstrated efficacy of Emgality (galcanezumab-gnlm) in patients with episodic and chronic migraine who had previously failed preventive treatment with Botox (onabotulinumtoxinA). Detailed results from a post-hoc analysis of three Phase 3 studies (Evolve-1, Evolve-2 and Regain) will be presented as a late-breaking presentation on Saturday, June 30 at the American Headache Society (AHS) annual meeting in San Francisco.
Lilly also announced that the intended brand name, Emgality, has been conditionally accepted by the U.S. FDA.
Emgality is a once-monthly, self-administered calcitonin gene-related peptide (CGRP) antibody currently under review by the FDA for the prevention of migraine in adults. A decision is expected by the end of September 2018.
“Despite currently available preventive options, nearly half of patients have discontinued these treatments due to side effects or lack of efficacy,” said Christi Shaw, president of Lilly Bio-Medicines. “Over the last two decades, Lilly has recognized and invested in efforts to explore innovative potential treatments for primary headache disorders, including Emgality, which is specifically designed for the prevention of migraine and cluster headache.”
Analysis Design
Evolve-1, Evolve-2 and Regain were Phase 3, randomized, double-blind, placebo-controlled studies that evaluated the efficacy of two doses of Emgality (120 mg and 240 mg) in patients with episodic or chronic migraine. This post-hoc analysis evaluated patients treated in the Evolve -1 and Evolve -2 studies for six months and the Regain study for three months.
The post-hoc analysis reviewed the mean change from baseline in the number of monthly migraine headache days and the proportion of patients with at least a 50 percent reduction in number of monthly migraine headache days in patients who had previously failed Botox due to lack of efficacy or tolerability issues, using integrated Evolve-1 and Evolve-2 results and Regain results.
Analysis Results
In this subgroup analysis, patients treated with both doses of Emgality who previously failed preventive treatment with Botox experienced a statistically significantly greater reduction in the average number of monthly migraine headache days, and a statistically significantly greater percent (at least a 50 percent) reduction in the number of migraine headache days, compared to patients treated with placebo.
- Average reduction in monthly migraine headache days: 3.91 days for 120 mg and 5.27 days for 240 mg compared to 0.88 days for placebo, p≤0.03 for both dosing groups compared with placebo.
- Mean percentages of patients with at least 50 percent reduction in monthly migraine headache days: 41.3 percent for 120 mg and 47.5 percent for 240 mg compared to 9.4 percent for placebo, p≤0.02 for both dosing groups compared with placebo.
As previously reported in these Phase 3 studies, the most commonly-reported adverse events were injection site reactions.
In this integrated analysis of patients who had previously failed treatment with Botox, patients treated with Emgality also had statistically significant improvements in quality of life, as measured by the Migraine-Specific Quality of Life Questionnaire (MSQ) and the Patient Global Impression of Severity (PGI-S) rating.
Emgality 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.
About the Evolve-1 and Evolve-2 Studies
Evolve-1 and Evolve-2 are six-month Phase 3, randomized, double-blind, placebo-controlled global trials evaluating the safety and efficacy of two doses of Emgality administered subcutaneously (120 mg or 240 mg once-monthly, following a 240 mg starting dose) compared with placebo in patients with episodic migraine.
To be eligible for the trials, patients must have experienced between four and 14 migraine headache days per month. Patients that participated in these trials had an average of 9.1 migraine headache days per month at baseline. The primary endpoint was the mean change from baseline in monthly migraine headache days over the six-month, double-blind treatment phase.
About the Regain Study
Regain is a three-month Phase 3, randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of two doses of Emgality administered subcutaneously (120 mg or 240 mg once-monthly, following a 240 mg starting dose) compared with placebo in patients with chronic migraine.
To be eligible for the trial, patients must have experienced at least 15 headache days per month, of which at least eight met criteria for migraine. Patients that participated in the trial had an average of 19.4 migraine headache days per month at baseline. The primary endpoint was the mean change from baseline in monthly migraine headache days over the three-month, double-blind treatment phase. In Regain, Emgality was further evaluated for an additional nine months of an open-label extension phase following the three-month, double-blind treatment phase.
(Source: Eli Lilly and Company)
Filed Under: Drug Discovery
