Allergan's ubrogepant is on a roll—the oral CGRP drug has hit the mark in a second phase 3 migraine trial, cementing the company's plans to file for approval in 2019.
The 1,686-patient study tested a 25-mg and a 50-mg dose of ubrogepant against placebo to treat a single migraine attack of moderate-to-severe headache intensity, with the higher dose meeting both co-primary endpoints.
After two hours, about 20% of patients in each treatment arm were pain-free, compared to 14% in the placebo group. Nearly 39% of patients who received the 50-mg dose no longer had the most bothersome migraine-associated symptom after two hours, compared to 27% of patients receiving placebo. The 25-mg group showed improvement (34%), but it wasn't statistically significant.
The company reported four cases in which aminotransferase liver enzymes were elevated by more than three times the upper limit of normal. They were seen in both placebo and treatment arms, and, according to a blinded panel of liver experts, could be explained without implicating ubrogepant.
The new data come on the heels of another successful phase 3 trial that investigated higher doses—50 mg and 100 mg—in migraines of moderate or greater severity. Both doses met the co-primary endpoints, putting up very close numbers: about 20% of patients in each arm were pain-free after two hours, while the drug alleviated the most bothersome symptom in about 38% of patients. Six patients had aminotransferase liver enzyme levels higher than three times the upper limit of normal.
Allergan is vying with Amgen, Biohaven, Novartis, Eli Lilly, Teva and Alder in the CGRP space. But those companies, with the exception of Biohaven, are all developing injectable monoclonal antibodies.
Allergan is racing Biohaven to get the first orally active GCRP-targeting drug to market, and last month, the Connecticut-based biotech looked to have pulled ahead. It announced that a pair of phase 3 trials showed that a single dose of rimegepant beat out placebo when it came to providing relief from pain or another most bothersome symptom two hours after dosing, with fewer patients on the active drug requiring rescue therapy with current drugs such as triptans. Rimegepant met its primary endpoints with similar numbers to ubrogepant, but was no more likely than placebo to increase aminotransferase, Biohaven said.