[Corrected, 8:58 am PT. See below.] Nobody has ever come up with a drug that can stop migraine headaches before they start. This will be the year that Bothell, WA-based Alder Biopharmaceuticals finds out if it can achieve that lofty goal, and change the way patients and physicians think about treating migraines.
Alder passed its first 96-patient clinical trial last year, which suggested a single dose of its injectable antibody for migraines was safe, potent, and potentially deliverable as a once-monthly shot. That result has prompted Alder to sprint ahead this year with a placebo-controlled study of 160 patients that’s designed to show investors, and partners, that this drug candidate is the real thing. The answer to that question should arrive by the end of this year, in time to see if Alder can stay near the front of an increasingly crowded field.
“Our data looks very, very good,” says Alder CEO Randy Schatzman. “It’s going to be a horse race of sorts.”
The prize here could be worth billions. An estimated 6 million people in the U.S. complain of chronic migraine headaches that strike at least 15 times a month. Instead of coming up with more pills, like the conventional generic “triptan” drugs, companies are striving to make long-lasting injectable antibodies that attack migraines in a different way, by pursuing a molecular target called calcitonin gene-related peptide (CGRP). Merck helped kick-start this competition when its conventional small molecule against this target had safety issues, but showed it was effective against migraines. The big idea in biotechland is that a genetically engineered antibody could block the same molecular pathway, but without causing the liver toxicity that derailed the Merck compound. There’s so much interest in migraine treatment today that an old reformulated drug from MAP Pharmaceuticals (NASDAQ: MAPP), which hasn’t yet won FDA approval, was acquired this week for almost $1 billion by Allergan.
For a while in 2010, when Alder was gearing up discovery work for became ALD403, it thought it might be the only company actively pursuing the idea of an antibody against CGRP. But the moment didn’t last long. Alder knew that Pfizer’s Rinat Neuroscience unit had a competing program, but various corporate restructurings put it on the shelf. The program recently got new life when Corey Goodman, a prominent neuroscientist-turned-Pfizer-executive-turned-venture-capitalist, scooped it up at Labrys Biologics. Lilly also spun out its CGRP antibody, with an $18 million investment from Atlas Venture and OrbiMed Advisors, into a new company called Arteaus Therapeutics. Amgen also has a competing program moving ahead in clinical trials, and Bristol-Myers Squibb is reported to be active here, too.
Researchers have known for many years that constricting blood flow to the brain can have some effect against migraine. The traditional triptan pills are thought to work this way for about half to three-fourths of patients. But there are limits, because the drugs can only be taken after migraine pain begins, and the drugs only last a couple of hours, allowing opportunity for so-called “rebound” headaches to strike back. The drugs also come with a warning that they can cause high blood pressure and other side effects like stroke.
The biotech drug developers of the world, Alder included, see a big new opportunity to constrict blood flow to the brain through the CGRP pathway. By being more targeted, the new drugs shouldn’t cause … Next Page »
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