Migraine Biologic Drug Candidate Meets Phase 3 Endpoints

Novartis recently announced positive results from the phase 3b LIBERTY clinical trial evaluating the efficacy and safety of investigational erenumab in patients with episodic migraines, according to a press release.

The experimental drug met the primary trial endpoint of more patients achieving at least a 50% reduction in monthly migraines from baseline compared with placebo.

Included in the study were 246 patients with episodic migraines who failed 2 to 4 previous preventive therapies. Patients were randomized to receive erenumab 140-mg or placebo for 12 weeks.

Erenumab also met all of the trial’s secondary endpoints, including reduction in monthly migraine days, reduction in days needing rescue medication, improvement in scores on the Migraine Physical Function Impact Diary tool, and 75% and 100% responder rates, according to the release.

Safety data from the new trial were consistent with its known profile.

The LIBERTY trial also includes an ongoing 52-week extension arm, according to the release.

"The LIBERTY trial is the only Phase 3b anti-CGRP study to demonstrate safety and efficacy in patients who have repeatedly failed other preventive treatments," said Danny Bar-Zohar, global head of Neuroscience Development for Novartis.

Novartis reported that erenumab is the only fully human monoclonal antibody that can selectively block the calcitonin gene-related peptide receptor, which plays a significant role in migraines, according to the release. Thus far, the safety, efficacy, and tolerability of erenumab have been investigated in more than 3000 patients.

Current migraine therapies typically have poor tolerability and lack efficacy, highlighting the need for novel treatments.

"The results add to the consistent body of evidence for erenumab across the full spectrum of migraine patients, from those trying preventive medication for the first time through to those who have failed multiple therapies and have been suffering for years,” Bar-Zohar said. “We look forward to making erenumab, the first targeted preventive option specifically designed for migraine, available to patients as soon as possible."