AR101 is currently being studied by Aimmune Therapeutics to induce desensitization in peanut allergic subjects. The peanut treatment, AR101, passed through phase 2 trials in 2016, protecting 100% of patients who ate 443 mg of peanuts (1.5 peanuts), 90% of those who ate 1,043 mg (3 peanuts) and 60% who ate 2,043 mg (7 peanuts). A single peanut weighs in at about 300 mg, the company says, while the average accidental exposure tends to hover around half a peanut, approximately 150 mg.
The active ingredient in AR101 consists of defatted lightly roasted peanut flour. Currently patients who stop treatment with AR101 will lose desensitization. Aimmune is also look into achieving sustained unresponsiveness, in which a patient is still protected even after taking a break from treatment. AR101 is designed to work with patients taking the drug at a doctor’s office every two weeks over a 20-week period to overcome their allergies to peanuts.
There are currently several trials underway for AR101, to see what is underway please click below:
The company is also looking for ways to desensitize to eggs and milk. Aimmune’s approach involves giving patients escalating doses of the allergen—starting very small—until it achieves a sufficient level of protection.
Recently the peanut patch, Viaskin missed its primary endpoint in clinical trials, putting its peanut treatment in doubt. The company is still forging ahead with its peanut desensitization treatment.
For patients who complete the trials with AR101, it would be helpful for accidental exposures to peanut. Patients would still not be able to eat peanuts, but it would reduce the risk of anaphylaxis if they ingest it. Most of the time, 1/2 peanut is ingested with these accidents and AR101 would protect these patients at much higher dosages.
To read more about Peanut Allergy, see below.
Aimmune therapeutics released a recent successful trial of AR101. 496 patients were enrolled from 4-17 years old, all patients had a history of peanut allergy. At first, they were fed 3 milligrams of the drug and eventually increasing to a maximum of 300 milligrams, equivalent to 1 peanuts. The regimen was over 6 months, where the patient continuing eating 1 peanut a day. Following the study, most patients were able to tolerate up to 600 milligrams (2 peanuts) of peanut protein, half were able to tolerate 1000 milligrams of peanut protein. Almost all experienced allergic reactions during the course of the trial. Epinephrine was required in some cases, 4% were considered severe, and 59% of the reactions were moderate, overall 14% needed epi. 20% in the active treatment group withdrew from the study because of adverse side effects.
Aimmune seeks to have FDA approval by the end of 2019.