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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
Patients with chronic migraine -- defined as having more than 15 days of notable headaches, at least 8 of which are migraines -- saw the number of days they had headaches plummit during trials of the drug ALD403, researchers at Alder Biopharmaceuticals report. Photo by BillionPhotos.com/Shutterstock
Patients with chronic migraine -- defined as having more than 15 days of notable headaches, at least 8 of which are migraines -- saw the number of days they had headaches plummit during trials of the drug ALD403, researchers at Alder Biopharmaceuticals report. Photo by BillionPhotos.com/Shutterstock

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.

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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.

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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.

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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.

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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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