New Migraine Drug Administered Four Times Per Year Shows Promise in Trials

The price of Alder Biopharmaceuticals stock surged on Monday after it announced positive results from a trial of a new migraine treatment. From Investor’s Business Daily:

Alder was following up on a phase-two trial that it had first reported last March, when 31% to 33% of patients (depending on the dose) who received a single intravenous infusion of Alder’s anti-CGRP antibody ALD403 enjoyed at least a 75% reduction in migraine days over 12 weeks. After 24 weeks, between 29% and 31% experienced the same reduction, vs. 20% of the control group.

If you’re a migraine sufferer, read that again…slowly: a single IV dose of this magic potion antibody was effective in reducing migraines for 12-24 weeks during the trial! I’m not exaggerating when I say that this could revolutionize the way migraines are treated.

Alder, a small biotech company, is competing with bigger names in the industry to bring an anti-CGRP antibody to the market. In March Reuters reported on the Alder trial:

Multiple doses of the drug, ALD403, were tested against a placebo in patients suffering from chronic migraines, those who experienced 15 or more headache days per month, of which at least eight were assessed as migraine days.

The two highest doses of the drug, 300 mg and 100 mg, brought about a 75 percent reduction in migraine days in 33 percent and 31 percent of patients respectively, meeting the main goal of the study.

Alder Chief Executive Randall Schatzman told Reuters, “We’re proposing that patients are dosed four times a year. Most other developers are looking at once-a-month dosing,” he said, adding that the treatment could potentially be self-administered.

CGRP stands for calcitonin gene-related peptide (CGRP). Researchers say that CGRP is involved in migraines at the molecular level. The connection was first discovered in the 1990s when triptans like Imitrex hit the market and it was discovered that CGRP was inhibited by them. While triptans were an amazing discovery and they’re a very successful treatment for many migraine sufferers, they are vasoconstrictors, so there is the potential for serious side effects. Because of that, they’re not recommended for many patients and they can’t be taken as often as many patients need them.

So researchers set out to find a way to block the CGRP — to do what the triptans do —without the vasoconstriction. First, they discovered that injecting CGRP into migraine patients intravenously could induce a migraine attack. Next, a CGRP-blocking antagonist called Telcagepant was developed and it was successful at preventing migraines. However, it was found to cause liver damage and the trial was halted.

Now researchers are testing a new generations of CGRP antagonists. ALD403 and a few other drugs in this category are, for now, meeting benchmarks for success in ongoing trials. Millions of migraine sufferers (myself included) are waiting to see if this could be the “magic bullet” treatment we’ve been waiting for. Unfortunately, even if the trials are successful, we’ll have to wait until at least 2019 before it hits our pharmacy shelves.

Migraine headaches are characterized by severe, throbbing, one-sided pain and sensitivity to light, sound, and smell. Patients also report nausea and vomiting along with visual disturbances. The headaches can be disabling and resistant to the current treatments on the market.

According to MigraineStatistics.com, there are more than 37 million Americans who suffer from migraines, and 2-3 million of those are chronic sufferers. Almost 5 million people in the U.S. have at least one migraine attack per month and 11 million say it is the cause for moderate to severe disability in their lives.