[Updated, 4:39 pm, see below] There aren’t many effective treatments out there for the millions of Americans who suffer from migraines. But over the past few years, a new class of drugs that might actually prevent these debilitating headaches from occurring—rather than just mute them when they happen—has been inching towards the market. One of them, from Alder Biopharmaceuticals, took a step forward today.
Bothell, WA-based Alder (NASDAQ: ALDR) said today that its experimental drug ALD403 met the primary and secondary goals of a Phase 2b study of over 600 patients with chronic migraines, who typically have headaches at least 15 days a month. Alder said a single intravenous infusion of the highest two doses of four it tested (300mg and 100mg) led to a statistically significant reduction in patients’ days with migraines over a 12-week span, compared to a placebo. The lowest dose (10 mg) was deemed “sub-therapeutic,” Alder said.
Alder said the drug’s safety profile was “consistent with earlier [studies],” though it didn’t provide any additional details.
Separately, the company also produced data from an early-stage study showing that it might be able to administer ALD403 once every three months via either an infusion or an injection just under the skin or into the muscle. How often the drug needs to be dosed, and whether it can be self-administered as opposed to given at the hospital, will be one of the differentiating factors between Alder and several similar, rival migraine drugs from Teva Pharmaceutical Industries (NYSE: TEVA), Eli Lilly (NYSE: LLY), and Amgen (NASDAQ: AMGN). Teva got its drug when it bought San Mateo, CA-based Labrys Biologics. Eli Lilly, of Indianapolis, got its migraine prospect through a deal with Cambridge, MA-based Arteaus Therapeutics.
These drugs—which are all in late-stage testing—are so-called calcitonin gene-related peptide (CGRP) antibodies, and what makes them potentially important is that they have a chance to help people ward off migraines before they happen. Though people can take generic triptan pills for migraines, those drugs only help reduce the pain from migraine headaches after they begin. Triptans also only last for a few hours (which can lead to rebound headaches), and can cause high blood pressure and other side effects. (This Bloomberg piece from last year has more on the race between Alder and its rivals.)
Like ALD403 and the other new experimental drugs, triptan pills work by blocking CGRP, a protein that helps trigger the pain signaling associated with migraines. But because the drugs from Alder, Teva, and others are antibodies, they do this in a more targeted fashion. The hope is that they can be dosed infrequently (say, in Alder’s case, every three months or less), actually prevent headaches, and not cause the cardiovascular side effects associated with triptan pills. But questions remain as to their effectiveness, durability, and safety, particularly if they’re to be taken chronically by migraine sufferers. The answers should come over the next few years.
About 38 million Americans suffer from migraines, and some 14 million of them have chronic migraines, according to the Migraine Research Foundation. About 12 percent of those with frequent or chronic migraines take preventative medications, such as beta blockers or botulinum toxin (Botox), which were developed to treat other health problems.
ALD403 is a critical drug for Alder, especially after Bristol-Myers Squibb decided to end a partnership with the company on an experimental rheumatoid arthritis drug, clazakizumab, in September 2014. Alder still hopes to move that drug forward, and is evaluating “strategic alternatives” to do so, according to a statement in February. ALD403 is the company’s most advanced drug prospect—the company began one Phase 3 trial in October, and expects to start a second one this year. The first Phase 3 study should produce results next year.
Some specific numbers from the Alder data:
—57 percent of the 114 patients on the 300 mg dose had a 50 percent reduction in migraine days through 12 weeks. 33 percent of patients had a 75 percent reduction, and 8 percent of patients were migraine-free. (Comparatively, 41 percent of placebo patients had a 50 percent reduction, 21 percent had a 75 percent reduction, and 3 percent were migraine-free.)
—54 percent of patients at the 100mg dose had a 50 percent reduction in migraine days over the course of the study. Thirty-one percent of patients had a 75 percent reduction in migraine days, and 5 percent were migraine-free.
Alder will also evaluate the results after 24 and 48 weeks of treatment. The company will hold a conference call this morning to discuss the results.
[Updated with stock price] Shares of Alder soared about 50 percent on Monday and closed at $25.70 apiece.