Axsome celebrates migraine PhIII win, shifting eyes toward a pair of Q4 submissions
One week after reporting a late-stage failure for its lead drug, Axsome is back with positive news: In the 302-person Phase III INTERCEPT trial, its experimental migraine drug hit both primary endpoints: Stopping migraine pain entirely and preventing pain from progressing beyond ”mild intensity.”
The trial win sets up a big fourth quarter for the 8-year-old company and keeps them on track to file for approval for the migraine drug, known as AXS-05. And despite the late-stage failure, they plan to file for approval on their lead depression drug, known as AXS-07, citing secondary endpoints and the high placebo rates that have long clouded depression trial results.
Axsome was hoping for a win with INTERCEPT, but far from depending on it. AXS-07 — a combination of the generic migraine drug rizatriptan and a version of the non-steroidal anti-inflammatory meloxicam — already beat placebo and rizatriptan alone in a Phase III trial of nearly 1,600 patients who had responded poorly to previous migraine therapies in December. After those results, SVB Leerink upped their odds of FDA approval from 60% to 100%.
The new trial was designed and launched primarily to assure a wider label — the equivalent of moving from second-line to first-line for a cancer medicine.
“Management noted that the study is a pure commercial play to inform product positioning, and the data readouts won’t have any impact on the upcoming NDA in 2H20,” Leerink’s Mark Goodman wrote in February.
If approved, though, the drug will enter a newly congested market. In the last two years, a series of injectable migraine prevention drugs have changed the outlook for many patients. And in just the last a few months, for the first time in years, new drugs have appeared for treating acute pain. Eli Lilly’s Reyvow was the first, in October, followed by Allergan’s Ubrelvy in December and Biohaven’s Nurtec in February.
On the primary endpoints, AXS-07 stopped all pain for 33% of patients compared with 16% in placebo. And, between 2 and 24 hours after the attack, it prevented pain from progressing beyond mild intensity in 74% of patients, compared with 47% for placebo.
“With INTERCEPT and the previously completed MOMENTUM Phase 3 trial in patients with a history of inadequate response to prior acute treatments, AXS-07 has now been evaluated in two positive well-controlled trials,” CEO Herriot Tabuteau said in a statement. “These trials demonstrate the efficacy of AXS-07 against potent active and placebo comparators, across a spectrum of migraine attack settings, regardless of the timing of migraine treatment, disease severity, or baseline pain intensity.”