The Israeli pharma came to the decision after a pre-specified futility analysis showed that fremanezumab was unlikely to meet the primary endpoint of a phase 3 trial in episodic cluster headache.
The primary endpoint of the late-stage trial was defined to be the mean change from baseline in the weekly average number of cluster headache attacks during the treatment period of four weeks.
Owing to the latest setback, Teva will stop the ENFORCE phase 3 clinical trial program, which also features a long-term safety study. In June 2018, a phase 3 trial under the same clinical development program, which was evaluating the migraine drug for the treatment of chronic cluster headache, was discontinued due to futility.
However, the company said that it will continue exploring other possible indications for fremanezumab, including the treatment of post-traumatic headache for which a phase 2 trial is currently in progress.
Teva senior vice president and global specialty clinical development head Tushar Shah said: “We’d like to thank the patients and investigators for their immense contributions to this study.
“Despite these results, we are continuing to evaluate if fremanezumab treatment can provide clinical benefits in additional diseases where anti-calcitonin gene-related peptide (CGRP) therapy may play a role in its pathophysiology.”
The Teva migraine drug has been designed to target the CGRP ligand, which is believed to be a well-validated target in the neurological condition. The drug functions by attaching itself to the CGRP ligand and thereby blocking its binding to the receptor.
Earlier this year, fremanezumab injection, which is marketed as AJOVY, was approved by the European Commission for the prophylaxis of migraine in adults who experience at least four migraine days per month.
Prior to that, in September 2018, AJOVY was approved by the US Food and Drug Administration (FDA) for the preventive treatment of migraine in adults. The FDA approval made the Teva drug as the first and only anti-CGRP treatment for the prevention of migraine with quarterly (675mg) and monthly (225mg) dosing options