Results from the Latest Clinical Trial on Peanut Allergies
A new experimental treatment for children with peanut allergies, called AR101, has given way to promising Phase 3 clinical trial results. A biopharmaceutical company from California, called Aimmune Therapeutics, led the study into how safe and effective this new treatment is. They collected data from 554 patients, aged 4 to 17, who suffer from peanut allergies. The study was conducted across 69 sites within the United States.
The researchers split participants into a control group and an experimental group, with the former group receiving a placebo treatment, and the latter grouping receiving AR101 The investigation was performed as a double-blind study, meaning that neither the participants nor their health care providers were aware of whether the participant had received peanut powder or placebo. The logic for using this double-blind approach is to ensure that there is no bias in evaluating peanut tolerance at the end of the trial.
By the end of the yearlong clinical trial, more than two thirds of the group that received AR101 could tolerate the equivalent of about two peanuts, or 600 mg of peanut protein powder, without experiencing an allergic reaction. By comparison, only 4% of those who had received only the placebo intervention could tolerate a 600 mg dose of peanut protein powder a year after the trial began.
The majority of those from the experimental group that could handle a 600 mg dose of peanut protein after a year of treatment could also handle a 1000 mg dose. Whereas only 2.4% of the placebo group could tolerate 1000-mg of peanut protein at the end of the trial, 50.3% of the experimental group could handle this larger dose without incident.
In addition to the promising results of AR101, with respect to the treatment’s ability to protect children against severe allergic reactions to relatively small doses of peanut protein, the study also showed promising results in terms of safety. Only a small proportion of study participants experienced serious adverse side effects.
Some interventions for peanut allergies aim to aggressively reverse allergies or allergic reactions so that patients can safely eat peanuts like those without allergies. The rationale behind AR101, however, was to simply protect children from accidental peanut exposures. Given that 2.5% of children are now allergic to peanuts, up 21% since 2010, treatments like AR101 that may help prevent severe reactions including anaphylaxis in the unfortunate event of peanut exposure are critical for protecting children and for providing peace of mind to those with peanut allergies, as well as their loved ones.