Alder Plans for FDA Filing After Migraine Drug Posts Strong Results

Xconomy Seattle — 

Alder Biopharmaceuticals’ migraine-prevention drug hit its main goal in a late-stage study, and the drug developer these early results keep it on track to file for FDA approval later this year.

Bothell, WA-based Alder (NASDAQ: ALDR) tested its drug, eptinezumab, in patients who have chronic migraine—more than 15 headaches per month. The company reported that patients in the Phase 3 study who received the drug experienced an average of 8.2 fewer migraines per month compared to 5.6 for those given a placebo, which Alder says is enough to be statistically significant. The results also appear to show the drug worked quickly. Alder reported that 52 percent of patients who received the Alder drug felt the migraine-prevention effects from day one, compared to 27 percent of those who received a placebo.

Following the announcement of the results this morning, Alder’s stock price rose more than 13 percent to $14.68 per share.

Alder’s Phase 3 study, known as PROMISE 2, enrolled 1,072 patients randomized to receive either an infusion of the Alder drug, or a placebo. Patients enrolled in the three-month study had an average of 16.1 migraine headache days per month. In addition to meeting the main goal of the study, the drug also appeared to have a long-lasting effect, at least for some patients. Alder says 15 percent of those who received eptinezumab experienced no migraines for the study’s full three months. Alder said that the safety and tolerability of the drug was similar to what was observed in earlier studies, but did not elaborate.

Eptinezumab is part of a new class of antibody drugs called calcitonin gene-related (CGRP) peptide inhibitors, which block a protein thought to play a role in the transmission of pain. In addition to chronic migraine, Alder has also tested the drug in patients who have episodic migraine, which is defined as having five to 14 headaches per month. Last year, Alder reported positive results for its episodic migraine study, PROMISE 1.

Alder says the preliminary results of PROMISE 2 mean that the company is on schedule to file an application for FDA approval in the second half of the year. But Alder is not the only company hoping for FDA approval of a CGRP drug for migraine prevention. Amgen (NYSE: AMGN) and partner Novartis (NYSE: NVS); Eli Lilly (NYSE: LLY); and Teva Pharmaceutical (NYSE: TEVA) have also developed CGRP drugs, which they have already filed with the FDA.

Alder is scheduled to present results from its migraine study later today during the J.P. Morgan Healthcare Conference in San Francisco.

Photo by Flickr user kizzzbeth via a Creative Commons license.