12:17 PM
 | 
May 15, 2018
 |  BC Extra  |  Clinical News

Lilly reports mixed data for CGRP mAb in cluster headache

Eli Lilly and Co. (NYSE:LLY) said galcanezumab met the primary endpoint in a Phase III trial to prevent episodic cluster headache but missed in a Phase III trial in chronic cluster headache. Lilly said it is working with global regulatory authorities to determine a path forward based on the episodic cluster headache data.

The humanized mAb targeting calcitonin gene-related peptide (CGRP) is under FDA review to prevent migraine in adults. Lilly expects a decision next quarter.

In the 106-patient episodic cluster headache trial, once-monthly subcutaneous 300 mg galcanezumab for two months significantly reduced mean weekly cluster headache attack frequency from baseline across weeks one to three by 8.7 attacks vs. 5.2 attacks for placebo (p=0.036). On a secondary endpoint, a significantly greater proportion of patients who received galcanezumab achieved at least a 50% reduction in weekly cluster headache attacks at week three vs. placebo.

In the 237-patient chronic cluster headache trial, once-monthly subcutaneous 300 mg galcanezumab for three months failed to significantly reduce mean weekly cluster headache attack frequency from baseline to three months vs. placebo. Lilly told BioCentury it is still reviewing the full data from the chronic cluster headache trial and cannot speculate at this time as to why the trial missed its primary endpoint.

The company said 85-90% of cluster headache cases are classified as episodic, with attacks occurring in periods lasting from seven days to one year that are separated by pain-free remission periods of one month or longer. The other 10-15% of cluster headache cases are classified as chronic, with attacks occurring for more than one year without a remission period, or with remission lasting less than one month.

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) is evaluating its fremanezumab (TEV-48125), a mAb targeting the CGRP ligand, in a pair of Phase III trials to prevent episodic and chronic cluster headache, respectively.

Fremanezumab is under FDA and EMA review to prevent episodic and chronic migraine in adults. Teva has exclusive, worldwide rights to fremanezumab from Pfizer Inc. (NYSE:PFE).

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