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Lilly’s Migraine Drug Phase III Trials Meet Primary Endpoint


Eli Lilly and Company LLY recently announced that its migraine candidate, galcanezumab, met primary endpoint in phase III studies. The data from the evaluation demonstrated that the galcanezumab led to statistically significant reduction in the number of migraine headaches days per month as compared with a placebo.

Lilly’s shares have outperformed the Zacks classified Large-Cap Pharma industry so far this year. Shares of the company rallied 9.0%, while the industry registered gain of 8.6%.

Coming back to galcanezumab, it is being evaluated for the prevention of episodic migraine in EVOLVE-1 and EVOLVE-2 as well as chronic migraines in REGAIN phase III studies in two subcutaneously injection dosages of 120 mg and 240 mg. On one hand, the EVOLVE-1 study showed an average reduction of 4.7 days for 120 mg dosage and 4.6 days for 240 mg dosage in comparison with a reduction of 2.8 days for placebo for both the doses.

On the other hand, the EVOLVE-2 study showed an average reduction of 4.3 days for 120 mg dosage and 4.2 days for 240 mg dosage in comparison with a reduction of 2.3 days for placebo. Notably, both the studies evaluated the drug over a six month period.

The REGAIN study treated patients over a three month period with galcanezumab and showed an average reduction of 4.8 days for 120 mg dosage and 4.6 days for 240 mg dosage in comparison with a reduction of 2.7 days for placebo.

All these three studies reported that the most common side effects of galcanezumab were pain and other reactions at the injection site. Detailed data from these studies are likely to be presented in scientific meetings and published in peer-reviewed journals, later this year.

Based on the positive data from the studies, Lilly plans to submit a Biologics License Application (BLA) to the FDA in the second half of 2017 and to other regulatory agencies internationally, later.

Additionally, the company is planning to evaluate the candidate for the treatment of cluster headache based on the results from the phase III study expected next year. Lilly’s migraine pipeline also includes lasmiditan for oral treatment of acute migraine in a phase III study. We note that Lilly added lasmiditan in its pipeline with the acquisition of Cambridge, MA-based biotech firm, CoLucid Pharmaceuticals in March.

In fact, Lilly's galcanezumab uses calcitonin gene-related peptide (CGRP) antibody for the prevention of migraine. Moreover, Amgen Inc.’s AMGN erenumab, Alder Biopharmaceuticals Inc’s ALDR eptinezumab and Teva Pharmaceutical Industries Limited’s TEVA TEV-48125 are being evaluated for treatment of the same diseases using anti-CGRP.

Zacks Rank

Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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