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news.A phase 3 clinical trial evaluating erenumab (AMG 334) in episodic migraine prevention has met its primary endpoint, demonstrating a statistically significant reduction in monthly migraine days versus placebo.
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Erenumab, which is being co-developed by Novartis and Amgen, targets and blocks the Calcitonin Gene-Related Peptide (CGRP) receptor, which is thought to have a key role in mediating the incapacitating pain of migraine.
The phase III ARISE study randomized 577 patients to receive once-monthly subcutaneous placebo or AMG 334 (70mg) in a 1:1 ratio.
Patients receiving erenumab experienced an average 2.9-day reduction from baseline in monthly migraine days versus an average 1.8-day reduction for placebo.
The safety profile of erenumab was same to placebo and consistent with earlier reported studies. Upper respiratory tract infection, injection site pain and nasopharyngitis were the most common adverse events.
Results from a second phase 3 study, STRIVE, are expected later this year.
Novartis global head of drug development and chief medical officer Vasant Narasimhan said: "The positive results from ARISE are especially encouraging because there are currently no treatment options specifically designed for the prevention of migraine.
“These findings, in combination with the recent positive data in chronic migraine prevention, add to the growing body of evidence that shows AMG 334 has the potential to help individuals worldwide suffering from episodic and chronic migraine."
Amgen has commercial rights for erenumab in the US, Canada and Japan, while Novartis has commercial rights elsewhere.
Image: Novartis global head of drug development and chief medical officer Vasant Narasimhan. Photo: courtesy of Novartis AG.