AR201 is currently being developed by Aimmune Therapeutics for the treatment of egg allergy. If Aimmune sounds familiar to you, it is because they will be releasing the first treatment of peanut allergy by the end of 2019, AR101.
Aimmune expects to initiate a Phase 2 clinical trial of AR201 for the treatment of egg allergy in 2019. Nearly 6 million people worldwide suffer from egg allergy and 800,000 in the United States. Egg allergy is one of the top 8 food allergens in the US, along with milk, wheat, soy, peanuts, nuts, fish and shellfish.
AR201 is expected to follow in the footsteps of AR101, where the allergen protein is gradually given in escalated doses until tolerance is achieved. It is intended to protect patients against accidental exposure only and not made for the person to eat the food liberally.
Only about 20% of people allergic to peanut outgrow their allergy, but 80% outgrow their egg allergy usually by 16 years of age.
The majority of children who are allergic to egg can eat it in a baked form. It will be interesting to see how AR201 will be used considering that most children will outgrow the egg allergy in the future and that they can eat it in at least the baked form.
We have discussed egg oral immunotherapy in the past and different protocols have been achieved with significant results. AR201 would be helpful as it would give a standardized and safe approach to achieve tolerance. As mentioned previously, AR101 for peanut works by gradually giving increasing doses of peanut protein and up dosing at the allergists office until the patient can tolerate a certain milligram dose of the food.
AR201 was submitted for an IND (individual new drug) application for 2019, and Aimmune expects to begin phase 2 trials in 2019. Other researchers who have tried a similar approach using their own protocols have achieved great success, so it is expected that AR201 will achieve favorable results for egg as well, just like AR101 for peanut.
There is no cost yet for AR101 nor AR201, it will be interesting to see how the company prices it. Stay tuned for more information as it comes out on AR201.