Food Allergy Research

‘Peanut Patch’ Heads to Phase III Trials

DBV Technologies recently announced it has received the green light from the Food and Drug Administration (FDA) to begin a global Phase III trial using Viaskin® Peanut (also known as the “peanut patch”). This is the first time that a drug for food allergy has reached Phase III – a step in the clinical trial process during which a drug or treatment is given to a larger group of people to confirm its effectiveness and collect information that will allow it to be used safely.

'Peanut Patch' Heads to Phase III Trial

The anticipated Phase III trial, Peanut EPIT Efficacy and Safety Study (PEPITES), which will enroll children ages 4 to 11, is expected to begin later this year following submission of the final clinical trial protocol and review by the FDA. PEPITES is planned as a randomized, double-blind, placebo-controlled trial with about 260 patients from 35 sites in North America, Australia and Europe.

DBV Technologies’ primary goal is to show that its therapy significantly reduces an individual’s sensitivity to peanut; this would help them avoid a life-threatening allergic reaction from accidental ingestion. This endpoint could potentially increase the study’s clinical relevance by better showing that the therapy increases safety for people with peanut allergy. This is the first specific therapy for food allergy to be approved to enter a Phase III trial, which is the final phase before consideration by the FDA for approval in the market.

The company also plans to conduct additional separate clinical trials in younger and older patients.

Earlier this year, DBV Technologies presented clinical data on the company’s Phase 2b trial, the results of which continue to support the effectiveness and safety of the peanut patch. This data showed that 50 percent of children were able to tolerate an oral challenge of at least 300 mg of peanut protein after 12 months of treatment versus 12.9 percent in the placebo arm. The study’s authors say this threshold dose of 300 mg peanut protein is clinically relevant, as reaching this level significantly reduces the risk of allergic reactions to potential peanut traces in foods.

UPDATE: Follow-Up Study of Peanut Patch Supports Long-term Safety and Efficacy

30 thoughts on “‘Peanut Patch’ Heads to Phase III Trials

  1. I am very excited about the new progress for peanut allergies. I am hoping that similar progress is made for life threatening allergies to milk products that have the same reaction as the peanut allergy.

  2. I don’t think they would do the patch test on severe allergic children . I think this is only for the not so severe . Which is very disappointing because I have a child who is severely allergic to peanuts and some tree nuts and his allergist said no way they could even think about it with his numbers being even on the low end .

    1. My child has been accepted to this study and they are actually looking for children with very severe peanut allergies. Having a mild peanut allergy is actually one of the disqualifying factors.

  3. Will the Sean N. Parker for Allergy Research Centre in Northern California be a part of this study? Do you know when Recruitment will start?

  4. Hi
    My daughter is 10 and has life threatening allergic reactions to all dairy, egg, beef, peanuts, cashews, almonds and intolerant to mango and cocoa. Not sure if we could take part in this trial but look forward to seeing the results and future implications for use with other allergies.
    Please advise and thanks for your great work
    Julie

    1. Have you ever heard of Nambudripad’s Allergy Elimination Therapy (NAET)? To read about it, It seems a little out there, but my daughter is receiving treatments (she does NOT have life threatening reactions, but are significant enough for me to seek out a treatment that does not consist of 5 different medications at once…) The practitioner has mentioned that she has treated many who have severe, life threatening allergies. It is less invasive than than scratch tests, and in my opinion, more thorough.

  5. This is a major breakthrough for peanut allergic patients . Wishing all success for this trial and hopes and prayers for the soon-to-be patch treatment.

  6. Wishing all success for this phase 3 trial.On success, this will be a great relief for all
    severe peanut allergic children or adults and their families.great going!!

  7. I have 3 children 5,4 and 2 years all with severe allergies to peanut. Would be very interested in getting them involved in the trial. Is the Cleveland clinic involved?

  8. My son is also severely allergic to peanuts and we are crossing our fingers that something is developed to help those with severe allergies. Below is another drug that is being tested and just completed the Phase II testing.

    Aimmune Therapeutics Announces Positive Phase 2 Study Results of AR101 for the Treatment of Peanut Allergy – See more at: http://www.aimmune.com/aimmune-therapeutics-announces-positive-phase-2-study-results-of-ar101-for-the-treatment-of-peanut-allergy/#sthash.KWZ7yyKa.dpuf

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