Experimental drug ALD403 prevents migraines in clinical trial

The company Alder reports its drug ALD403 prevented migraines in those with chronic migraine during a three-month clinical trial.
By Stephen Feller   |   March 28, 2016 at 1:25 PM
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BOTHELL, Wash., March 28 (UPI) -- The drug ALD403 prevented migraines in chronic migraine patients during a clinical trial, according to the company developing it.

Alder Biopharmaceuticals announced preliminary data from the phase 2b trial for ALD403, a monoclonal antibody injected quarterly to prevent migraines in patients with chronic conditions.

ALD403 prevents migraines by blocking calcitonin gene-related peptide, or CGRP, a protein that previous studies have shown plays a role in the initiation of migraines and heightened sensitivity to pain during them.

Results from phase 1 of the PROMISE 1 study were similar, according to company officials, with plans to publish results and analysis, as well as to start PROMISE 2 and develop a self-injected version of the drug.

Although the company said it would not be releasing top-line data from the study until 2017, it nonetheless announced preliminary findings today, and will likely pursue accelerated approval from the U.S. Food and Drug Administration as a result.

"Today's ALD403 Phase 2b data confirm and expand on our previous data demonstrating robust efficacy in migraine prevention in a severely afflicted patient group," Dr. Randall Schatzman, president and CEO of Alder, said in a press release.

For the trial, results of which have not yet been published in a medical journal, 617 chronic migraine patients were randomized to receive either 10 milligrams, 30 milligrams, 100 milligrams or 300 milligrams of ALD403 or a placebo at the start of the study, and then again 12 weeks later.

All of the participants were between ages 18 and 55, had been diagnosed with migraines before age 35 and experienced the condition for more than a year. All of the patients also had at least 15 headache days, with more than 8 assessed as migraines and at least five migraine attacks reported during the screening period before the study.

Of patients given 300-milligram and 100-milligram doses, 33 percent and 31 percent respectively experienced a 75 percent reduction in migraines during the first 12-week period of the study. More than half of patients receiving 30 milligrams of the drug at the start of the study reported a 50 percent reduction in migraine days per month.

The company will follow up with PROMISE 1 participants at 24-week and 48-week points, when the study ends, and will start PROMISE 2 in late 2016. Alder also plans to develop a version of ALD403 that patients can self-inject, either to complement injections by a doctor or in place of them.

Schatzman said Alder will request accelerated approval of the drug from the FDA based on the PROMISE 1 results, as well.

"Evaluation of ALD403 continues to exhibit a potential best-in-class profile, which includes immediate, significant and durable migraine prevention with infrequent quarterly dosing," Schatzman said. "Today's data also support our quarterly dosing strategy via a single intravenous, subcutaneous or intramuscular injection."

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