Not everyone made it through, though, and that’s because of side effects related to the treatment itself: patients are ingesting the very thing they’re allergic to.
“At first we almost didn’t do it because it was like eating the thing that I was avoiding at all costs for my whole life,” said Will. Occasional stomach aches are the worst side effect, he said.
The up-dosing process takes six months, and patients then stay on a maintenance dose equivalent to about one peanut a day.
Aimmune plans to file for regulatory approval by the end of this year. If it’s successful, Baird’s Skorney estimates the therapy could draw peak sales in 2025 of $1.3 billion worldwide.
It’s not the only new treatment in development, though. On almost a parallel track is French biotech DBV Technologies. It too, delivers a small amount of peanut protein each day, but its treatment has a few significant differences.
First is the delivery method: DBV’s therapy is administered with a patch that’s worn on the child’s back. Next is the dose: Every day, patients are administered the equivalent of one one-thousandth of a peanut via the patch, which is called Viaskin. The dose doesn’t increase the way Aimmune’s does.
“It slowly desensitizes the child over time,” Kevin Trapp, DBV’s chief commercial officer, told CNBC. “The child is getting about a peanut over three years.”
What kind of protection does that translate into? In late-stage clinical trial results reported last October, DBV found that patients treated with Viaskin could tolerate an average of 900 milligrams of peanut protein after 12 months, compared with 360 milligrams for those on placebo. The study didn’t meet its primary statistical goal, however: a difference in response rates between the active and placebo arms.
Nonetheless, DBV also plans to file for regulatory approval by the end of this year, Trapp said. He notes the therapy is well-tolerated, with some skin reactions where the patch adheres as the main side effects.
Skorney says the choice between Aimmune’s and DBV’s treatments may come down to efficacy versus tolerability.
“When we talk to physicians and families, there’s this gravitation toward Viaskin just in terms of: this is so easy, you just put it on your kid and don’t have to worry too much; you’re not going through the cumbersome and sometimes intolerable step-up process” that Aimmune’s treatment requires, Skorney explained. “But I think you lose some efficacy because of that more modest approach.”
He’s more bullish on Aimmune’s prospects.
“One of the things I like about Aimmune is you walk out of the physician’s office knowing how much your kid can tolerate,” Skorney said. “The data for Aimmune is much clearer; there’s much more of a magnitude of benefit.”