Eli Lilly spent close to a billion dollars to get its hands on the migraine drug lasmiditan, bagging CoLucid in January as a way to build its pain drug franchise. And it’s paying off today with another round of positive Phase III data as Lilly navigates it way to an expected regulatory filing next year.
Lilly hopes to differentiate this drug by focusing on the drug’s ability to deliver fast relief from severe pain. And while its new Phase III data is dogged by high placebo responses, researchers were able to nail down statistically significant improvements in response in the drug arms.
Two hours after taking the drug or a placebo, here were the responses by dosage: 28.6% for 50 mg (p=0.003); 31.4% for 100 mg (p<0.001); 38.8% for 200 mg (p<0.001) and 21.3% for placebo.
Investigators also nailed an endpoint on freeing patients of their most bothersome symptom, whether that was nausea, sensitivity to sound or sensitivity to light.
The data: 40% for 50 mg (p=0.009); 44.2% for 100 mg (p<0.001); 48.7% for 200 mg (p<0.001) and 33.5% for placebo.
Eli Lilly was drawn to this drug — which they had outlicensed early on to CoLucid, on the first round of Phase III data. This is the second. And if a third single-arm safety study holds up, they’ll be ready to roll.
The CoLucid buyout was Dave Rick’s first M&A deal as CEO at Lilly. The program joined Lilly’s Phase III migraine drug galcanezumab — a CGRP therapy in a crowded field of players — and a collaboration the pharma giant has with Pfizer on tanezumab, an NGF drug.
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