Amgen ($AMGN) says it got the positive data it was looking for from a Phase II study of AMG 334, one of several experimental migraine drugs that share the same target and are in the running to compete against an old generation of drugs on the market.
AMG 334 essentially bought migraine patients an average of a little more than one extra day per month free of the debilitating affliction, compared to the placebo arm. Starting with a baseline average of 8.7 days of migraines per month, the CGRP receptor-targeted drug produced an average of 3.4 fewer migraine days against the 2.28-day drop in the placebo arm. There was a similar drop in headache days (-3.54 vs. -2.39) and monthly migraine-specific medication use days (-1.64 vs. -0.69).
Amgen says the drug is now headed into a Phase III study later this year.
This drug is one of several in a new crop of CGRP treatments in the pipeline. For some time now, migraine sufferers have relied on triptans for relief, which constrict blood vessels in the brain as a way of spurring relief. A significant number of patients, though, don't respond to triptans. By going after CGRP, Amgen believes it can blaze a new mechanism of action that can do the same in a more targeted fashion that can help more patients. And there are several other companies in pursuit of the same goal.
Alder Biopharmaceuticals ($ALDR) plans to release topline data Phase II migraine data for their lead drug, ALD403, in the second half of this year while launching two Phase IIb studies. Last summer Teva ($TEVA) jumped into the race, buying Corey Goodman's Labrys Biologics and its CGRP drug LBR-101, a drug that started at Rinat, was acquired by Pfizer ($PFE) and then spun out.
Then there's Arteaus, a biotech funded with cash from Atlas and Orbimed, which took an Eli Lilly ($LLY) program for the anti-CGRP antibody LY2951742 and pushed it through proof-of-concept work as one of the initial projects undertaken by the Atlas Venture Development Corp. under David Grayzel. Lilly licensed the drug back last year, registering a $57 million charge for the deal. Bristol-Myers Squibb ($BMY) has also reportedly been working on another such program called BMS-927711. But there have been some tough failures in this space as well, with earlier attempts by Merck ($MRK) and Boehringer missing the mark on this brain chemical.
The Amgen data were presented at the 17th Congress of the International Headache Society in Valencia, Spain.
While Amgen and others have been looking to develop a new generation of migraine drugs, though, there's also been a debate over whether blood vessel constriction is the right objective. Some researchers have been exploring the pain signals that are sent by neurons as scientists make fresh advances in understanding how the brain works--or stumbles.
- here's the release