Co-primary endpoints were met when it came to a phase 3 trial of Allergan’s oral CGRP drug ubrogenpant. In the two hours after dosing, the drug provided much more relief than the placebo to intense migraine patients. On the other hand, the size of the effect, and the cases of increased liver enzymes leaves room for doubt about its forecast.
More than 1,300 adults were enrolled by investigators in the trail, and they were randomized. They were given one of two doses of ubrogenpant or placebo. The patients were all treated for one migraine attack of moderate or greater intensity.
Two hours had gone by and about 20% of the patients in the ubrogenpant arm didn’t have pain. These results are being compared to 12% in the placebo cohort. This was all the evidence needed for the trail to meet its first co-primary endpoint. Another co-primary endpoint was hit that tested the drugs effect on each patient’s most irritating symptom after two hours. The drug has eased the symptom about 38% of the time, compared to 28% of the time with the placebo.
FDA approval has been set up for Allergan in 2019. This is assuming that it clears a second phase 3 trial when it reports results later in 2018. The more important debate is whether Allergan is safe and efficient enough to turn ubrogenpant into a vital commercial product.
In terms of safety, Allergan had six cases that reported aminotransferase liver enzymes were heightened by more than three times the upper limit of normal. According to Allergan, these effects can all be explained without accusing ubrogenpant. The cases will be examined very closely due the the history of liver toxicity issues associated with coral CGRP drugs.
The point being that Allergan needs to convey that ubrogepant maximizes the safety and efficacy of generic triptans. Biohaven forecasts to post phase 3 data on rimegepant in the first half of this year.
Plenty of other companies are producing CGRP-targeting drugs, but the leaders are all developing injectable monoclonal antibodies. Amgen, Novartis, Eli Lilly, Teva and Alder are all apart of this competition. Allergan stands alone from the group as it is producing an oral small molecule drug.
In 2015, Allergan acquired ubrogenpant and related assets from Merck for $250 million. The concerns about liver toxicity undermined the potential significance of the six cases of elevated enzymes to the potential buyers of ubrogenpant.