May 15, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Amgen , headquartered in Thousand Oaks, Calif., announced today results from its Phase II trial for AMG 334, a drug for the prevention of migraine headaches.
Trial participants were given a placebo or AMG 334. Patients in the AMG group that received a 70 milligram dose showed a statistically significant 3.4-day reduction in days per month of migraines compared to 2.28 days in the placebo group. In other words, the drug appears to give patients an extra day per month of no migraines.
“Migraine is a complicated, underdiagnosed neurological condition that has significant impact on the everyday activities of those who live with it, and for the millions of people around the world who are affected by this disease, significant unmet therapeutic need persists,” said Sean Harper, executive vice president of Research and Development at Amgen in a statement. “We are encouraged by these Phase II data, which further validate AMG 334 as a potential preventive treatment for episodic migraine.”
AMG 334 is a human monoclonal antibody. It inhibits the calcitonin gene-related peptide (CGRP) receptor, which is linked to migraine and other headaches. Studies have found that when CGRP is injected into individuals with migraines, the migraine is delayed.
The more common approaches to migraine treatment are triptans, although many patients do not respond to triptans. Triptans marketed in the U.S. include Imitrex and Amerge, both manufactured by GlaxoSmithKline , Zomig (Impax Pharmaceuticals , Maxalt (Merck & Co. , Axert (Janssen Pharmaceuticals, a Johnson & Johnson company), Frova (Endo Pharmaceuticals and Relpax (Pfizer Inc. .
Triptans constrict blood vessels in the brain and are not preventative.
There are a number of other companies working on CGRP-related migraine treatments, including Alder Biopharmaceuticals Inc., Teva Pharmaceutical Industries Ltd. , which bought Labrys Biologics and its CGRP drug LBR-101, and Arteaus.
Arteaus has something of a complicated history. In January 2014 the company announced that Eli Lilly and Company , based on Phase II data, had acquired all the development right for a CGRP antibody Arteaus was studying, LY2951742. This molecule was discovered by Lilly researchers, then licensed to Arteaus for a clinical proof-of-concept study. Arteaus was founded in 2011 with $18 million from Atlas Venture and OrbiMed after the rights to the compound were acquired.
Israel-based Teva Pharmaceutical Industries (TEVA) announced in February 2015 positive results from a Phase IIb study of TEV-48125, its CGRP monoclonal antibody for migraine. No safety or tolerability issues were identified.
The Amgen study had secondary endpoints of a 50 percent responder rate, monthly migraine attacks, and safety and tolerability. The most common side effects were fatigue, influenza, nasopharyngitis, arthralgia and back pain.
According to market analysts the global market for migraines is expected to grow at a CAGR of 3.54 percent from 2014 to 2019. The market was rated at about $3.3 billion in 2011 in the U.S., Europe and Japan, and is expected to hit about $5.8 billion by 2021.
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