Clinical Trial of Peanut Pill Shows Promise for Severe Peanut Allergy Sufferers
This is excellent news! Scientists have been working on ways to manage or prevent severe or life-threatening reactions in peanut allergy sufferers. And it looks like they’re very close to finding the answer. A new peanut allergy pill just completed it’s phase 3 clinical trial, and the results are incredibly promising. The stress of managing a life-threatening peanut allergy is enormous on sufferers and caretakers, so being this close to getting some help must be a huge relief.
The daily peanut allergy pill won’t cure someone of their peanut allergy. But, during clinical trials, it proved successful in staving off severe and life-threatening reactions to peanut proteins.
Pharmaceutical company Aimmune Therapuetics developed the daily pill, currently called AR101. The pill is a capsule filled with peanut protein. The idea behind the treatment is that measured and gradual exposure to the protein can train the body to tone down it’s reaction. For someone with a severe peanut allergy, exposure to as little as 30 milligrams of peanut protein can trigger a dangerous and potentially deadly immunological response. For comparison, ONE PEANUT contains anywhere between 250 – 350 milligrams of the protein.
The study, which lasted a year, included 496 kids between the ages of 4 – 17. The kids in the study all had allergies so severe that ingesting 30 milligrams of peanut protein triggered a dangerous reaction.
In the blind trial, half the children received AR101, and half received a placebo. No one, including the researchers conducting the study, knew who got what. The kids who were given AR101 took the pill daily, with protein doses increasing over time. By week 22, every child receiving the drug were ingesting 300 milligrams of peanut protein a day.
After 48 weeks, every kid in the study underwent a food challenge. They were given increasing doses of peanut protein every 20 – 30 minutes (while being closely monitored, of course). Their “safe limit” of protein was the amount they received when their reactions went from none/mild to moderate.
Here’s where it gets really interesting: over 67% of kids who were on the AR101 regiment could tolerate single doses of 600mg of peanut protein, or over 1000mg total over two and a half hours! Conversely, only 4% of kids who were on the placebo were able to achieve the same tolerance levels. Additionally, over half of the AR101 kids could handle the maximum tested amount, 1000mg at once or 2000mg over three overs. Only 2.4% of placebo kids were able to do that.
Participants who got the AR101 during the trial have remained on the pill. Those who got the placebo have begun taking the actual drug. They’ll continue to be monitored to track their progress. Researchers are hoping to conduct a similar study with adults.
So, it is still a few years away from FDA approval. However, the possibility of a peanut allergy pill on the horizon is HUGE for people who deal with this life-threatening allergy every day.