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Allergan’s Migraine-Reducing Pill Hits Study Goals, Heads to Phase 3

Xconomy New York — 

An experimental Allergan pill meant to help reduce the frequency of migraines met the main goals of a key study, bolstering its chances of eventually being in the mix with a new wave of injectable migraine-preventing therapies.

The results announced Monday for the Allergan (NYSE: AGN) drug, atogepant, come a month after Amgen (NASDAQ: AMGN) won FDA approval of erenumab (Aimovig), the first marketed drug in this new class of migraine treatments. But Allergan’s results are particularly notable because atogepant is a pill. Amgen’s migraine drug, and several others still awaiting an FDA decision, are administered with a needle.

Investors welcomed the news for Allergan, nudging the company’s shares up $1.20 to $171.55 per share.

Atogepant is part of a class of new drugs called calcitonin gene-related peptide (CGRP) inhibitors. These drugs block CGRP, a protein believed to play a role in the transmission of pain. The goal of these drugs is to block CGRP before the cascade of activity leading to migraine pain begins, preventing the onset of a migraine altogether. These drugs don’t stop all migraines but in clinical testing, injectable CGRP drugs from Amgen, Eli Lilly (NYSE: LLY), Teva Pharmaceutical (NYSE: TEVA), and Alder BioPharmaceuticals (NASDAQ: ALDR) have reduced the average number of days per month that patients experience migraine attacks.

Ireland-based Allergan, whose U.S. headquarters is in Madison, NJ, tested its migraine-prevention pill in a Phase 2b/3 study enrolling 834 patients who have episodic migraine—between four and 14 days of migraine pain per month. The patients were randomized to receive either a placebo or one of five different doses of atogepant over the course of 12 weeks. Allergan said all of the atogepant groups had a statistically significant reduction in the average number of migraine days per month. The 87 patients on a high dose of atogepant, for instance, had an average of 4.14 fewer migraine days per month, compared to an average of 2.85 less migraine days for the 178 placebo patients.

Atogepant is one of two pills Allergan is testing in migraine patients. The other drug, ubrogepant, is an acute treatment taken after a migraine attack. Earlier this year, it succeeded in the first of two Phase 3 trials, though the liver enzymes of a few patients in the study spiked, a potential safety concern.

That didn’t happen in this trial, however. The most common side effects reported Monday by Allergan were nausea, fatigue, and infections in the nasal passages and urinary tract. There were no signs of liver enzyme elevations. ISI Evercore analyst Umer Raffat wrote that those results help validate the safety of CGRP-blocking pills. That’s a positive for competitor Biohaven Pharmaceuticals (NYSE: BHVN) of New Haven, CT, as well. Biohaven’s drug rimegepant, also an acute treatment, succeeded in two late-stage studies in March.

Raffat also noted that Allergan’s study showed evidence of “hyper-responders”—patients who display a particularly strong benefit from treatment. Hyper-responders were seen in clinical studies testing injectable CGRP drugs as well. While such findings suggest that there are patients for whom CGRP therapy would be particularly beneficial, drug companies do not yet have a way of finding out in advance who these patients are.

Allergan will present additional data from the study at an unspecified future scientific meeting. In the meantime, it will move atogepant into Phase 3 studies after talking with the FDA.

Photo by Flickr user Brandon Giesbrecht via a Creative Commons license