Lilly’s Emgality shows favourable profile in Phase III studies

15th July 2019 (Last Updated August 8th, 2019 12:04)

Eli Lilly has reported positive data from post-hoc analyses of three Phase III clinical trials, REGAIN, EVOLVE-1 and EVOLVE-2, of its migraine drug Emgality (galcanezumab-gnlm).

Lilly’s Emgality shows favourable profile in Phase III studies
Teva discontinues cluster headache programme following futility analysis. Credit: Gerd Altmann from Pixabay.

Eli Lilly has reported positive data from post-hoc analyses of three Phase III clinical trials, REGAIN, EVOLVE-1 and EVOLVE-2, of its migraine drug Emgality (galcanezumab-gnlm).

Emgality is a monoclonal antibody that targets calcitonin gene-related peptide (CGRP).

The drug is approved in the US for the preventive treatment of migraine, as well as treatment of episodic cluster headache.

Compared to placebo, the drug improved functional gains in the performance of daily activities limited by migraine.

Findings from the three double-blinded, placebo-controlled studies revealed a decrease in disability due to migraine in greater proportions of subjects in the Emgality-treated group.

In the REGAIN study involving participants with chronic migraine, a statistically significant increase of 46.2% was observed in the proportion of patients having ‘little or no disability’ following three months of therapy with Lilly’s drug.

A pooled analysis of EVOLVE-1 and EVOLVE-2 trials in episodic migraine showed 66.1% more chance of ‘moderate to very severe disability’ patients at baseline shifting to ‘little or no disability’ after six months on Emgality versus placebo.

The drug also led to improvements across all seven measures of the Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive Domain (MSQ-RFR).

Lilly Bio-Medicines Neurology Development vice-president Gudarz Davar said: “Migraine is the second leading cause of disability in the US and can severely impact people's lives. Emgality gives people a chance to reduce their monthly migraine headache days.

“Given the diverse disability and restrictions imposed by migraine, it is important to understand whether treatments like Emgality can lead to improvements in people's migraine-related disability and restrictions imposed on their daily activities, relationships, productivity, and free-time.”

In May this year, the company announced positive results from the EVOLVE-1 and EVOLVE-2 trials.