ELI LILLY AND COMPANY: Lilly's Galcanezumab Meets Primary Endpoint in Phase 3 Study Evaluating Galcanezumab for the Prevention of Episodic Cluster Headache

Source: Eli Lilly and Company

Eli Lilly and Company issued the following announcement on May 15.

Eli Lilly and Company (NYSE: LLY) announced today that galcanezumab met its primary endpoint in a Phase 3 study of patients with episodic cluster headache, demonstrating statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period. A statistically significantly greater percentage of patients treated with galcanezumab also achieved at least a 50 percent reduction in weekly cluster headache attacks compared to placebo at Week 3, the gated secondary endpoint.

The observed safety and tolerability profile was consistent with previous studies that evaluated galcanezumab for the prevention of migraine. In this study, 8 percent of patients treated with galcanezumab discontinued treatment during the study compared to 21 percent of patients treated with placebo. Four percent of patients treated with galcanezumab discontinued treatment during the study due to adverse events compared to 2 percent of patients treated with placebo. Discontinuations due to lack of efficacy occurred in 2 percent of patients treated with galcanezumab, compared to 14 percent of patients treated with placebo.

"Cluster headache can be difficult to evaluate in clinical studies, which has contributed to few available treatment options for cluster headache, often considered the most severe pain one can experience," said Christi Shaw, president of Lilly Bio-Medicines. "The positive results in episodic cluster headache are truly a landmark moment—both for people living with cluster headache and for our researchers at Lilly, many of whom have spent more than two decades researching and developing innovative, non-opioid treatment options for diseases like migraine and cluster headache."

Lilly also conducted a separate Phase 3 study for patients with chronic cluster headache, which represents 10 to 15 percent of cluster headache cases.1 This study did not meet its primary endpoint.

Based on results from the episodic cluster headache trial, Lilly is working with regulatory agencies around the world to determine the best path forward. Episodic cluster headache represents 85 to 90 percent of cluster headache cases.1

These studies, which evaluated a combined 343 patients, are the largest controlled preventive trials conducted in cluster headache to date.

"It is hard to articulate the devastating impact that cluster headache can have on those of us living with the disease. Many people living with cluster headache spend years searching for effective treatment options to help ease an excruciating level of pain," said Bob Wold, a patient living with cluster headache and founder of Clusterbusters, Inc. "We are very excited by these results and galcanezumab's potential as a new treatment option for people living with cluster headache, many of whom have spent years feeling ignored and alone in their struggle."

Episodic Cluster Headache Study Results

The episodic cluster headache study included a two-month treatment period comparing galcanezumab to placebo. Patients with episodic cluster headache treated with galcanezumab (300 mg once-monthly) experienced statistically significant differences in the reduction of weekly cluster headache attacks compared to patients treated with placebo across weeks one to three of the two-month, double-blind treatment period (-8.7 for galcanezumab compared to -5.2 for placebo, p=0.036), the primary endpoint of the study.

In May 2017, Lilly announced positive data from three Phase 3 studies (EVOLVE-1, EVOLVE-2 and REGAIN) evaluating galcanezumab for the treatment of chronic and episodic migraine. In these studies, galcanezumab demonstrated statistically significant reductions in the number of monthly migraine headache days compared to placebo at both studied doses (120 mg and 240 mg once-monthly).

The FDA is currently reviewing galcanezumab for the prevention of migraine in adults. A decision is expected in the third quarter of 2018.

Original source can be found here.

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