What was your reaction when you saw that?
Dr. Burks: We had expected that it would be an incremental amount, not 50% greater the second year that would tolerate the challenge. However, then we wanted to try to find out if that treatment can be permanent rather than just sustain the change in threshold while you are on the treatment. We took them off the treatment at the end of those 22 months. So, 75% were able to tolerate the food while on treatment, but we stopped the treatment and then that number goes back down to about 27.5%. So, many of them lost that protection just in that month.
So it seems like it can help a lot of people, but is it ready to be widespread yet?
Dr. Burks: If you think about the normal development process of a new drug, which what is being done is in fact using a food as a drug to treat someone and walking through the FDA where there is a Phase 1, Phase 2, and Phase 3 process. This study is kind of the in the middle of a Phase 2 process. We want to know more about the safety of which this study did and we have proven the efficacy in a blinded study. More Phase 2 and then more Phase 3 studies need to be done before we can say that it is the right thing to do.
So do you have plans for that next phase?
Dr. Burks: So, the Consortium of Food Allergy Research has plans with egg and other allergens to go to the next step. There are also national organizations, like The Food Allergy and Research and Education (FARE), a nonprofit foundation, and others are looking at ways to try to gather the support to do that next series of Phase 2 and Phase 3 studies. So, we really could have a product that would be approved that can be used for treatment.
What would treatment be like? Would it be like a daily pill that they would take that would contain some of that egg powder? What would be the end goal for treatment if this works?
Dr. Burks: The first goal really would be for the development of a treatment that would protect a child from an accidental reaction. The second goal would be to develop a treatment that we can actually give someone for a period of time and make that disease go away. It may be a daily powder put on food or a capsule or some other way. I think that is what remains to be determined in the rest of those phases 2 and phase 3 studies.
When can we expect those to start or have they started?
Dr. Burks: I think some have already started, nationally and internationally, trying to develop other protocols so we can get a better idea.
What are the implications of this for other food allergies, like nuts and some of the more common ones?
Dr. Burks: If this paradigm works for egg allergies, which there are indications that it does, there is not any reason to believe that we cannot do this same type of process for milk, peanut, for other tree nuts, and for shellfish. Based on previous similar studies, that same paradigm will work for those other foods.
So this is pretty exciting stuff then?
Dr. Burks: I think the two things that we get out of the study: one is that there is promise for the development of a treatment; that this is an exciting development that really is in the middle stages of a new product being developed; and the second thing is that it really is still in the development. We are not ready to do this clinically yet. It is not something to be used in practice at this time. It does give us promise, but we are not quite there yet.
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