Sharon Chinthrajah
Researchers at the Stanford University School of Medicine are seeking adults with peanut allergies to participate in two clinical trials of drugs that may reduce the severity of allergic reactions.
One is a phase-1 trial that will test the tolerability of a vaccine-based treatment intended to lessen the severity of allergic responses. The other is a phase-2 trial examining the effectiveness of an antibody drug aimed at reducing the inflammatory response.
Millions of people in the United States are allergic to peanuts, one of the most common and deadly food allergies. There is no pharmaceutical treatment for this allergy. Oral immunotherapy, in which patients consume tiny amounts of the food allergen, such as peanut proteins, may help desensitize the immune system - but the approach requires regular exposure to the allergen. The goal of these new treatments is to mitigate allergic responses to peanuts and other food allergens.
"It will be exciting to see what effects these drugs have in food-allergic patients and if it is different compared with oral immunotherapy," said lead investigator Sharon Chinthrajah, MD, a clinical assistant professor of pulmonary and critical care medicine and of pediatric allergy and clinical immunology.
A new type of DNA vaccine
The vaccine, ASP0892, is a new type of DNA vaccine intended to desensitize the immune system to allergens, including peanut proteins. Unlike preventive vaccines that train the immune system to recognize foreign invaders, this drug could help train the immune system to scale back inflammatory responses to allergens and ease the associated symptoms. Instead of exposing the immune system directly to allergens such as peanut proteins, DNA vaccines bring the code for the protein into immune cells, which then produce it within the cells, according to Astellas Pharma Global Development Inc., which is developing the vaccine.
Stanford is one of seven sites in the United States conducting this phase-1 clinical trial sponsored by Astellas. Stanford is recruiting up to 10 participants: Adults aged 18 to 55 with a diagnosed peanut allergy, with no history of severe anaphylaxis, are eligible to enroll. Participants will visit Stanford once every two weeks for a total of four treatments over the course of a year.
Assessing efficacy, tolerability of antibody
The other Stanford study is a phase-2 clinical trial of an antibody drug, ANB020. The trial will assess the efficacy and tolerability of the compound, which is believed to reduce the immune response to allergens, like peanut proteins. The antibody targets an important molecular node in the inflammation response pathway to reduce sensitivity to multiple allergen types, according to the drug developer, AnaptysBio Inc.
For the trial of the antibody drug, Stanford is recruiting up to 20 adults aged 18 and older with a diagnosed peanut allergy and no history of life-threatening anaphylactic reactions. Participation will span about 60 days, and participants will undergo an allergy response test before and after the treatment. This trial is sponsored by AnaptysBio Inc. A phase-1 clinical trial has already been completed in Australia.
In both trials, participants will be randomized to receive either the treatment or a placebo and will not know which compound they receive until the treatment period is over.
For more information, email snpcenterallergy.inquiry@stanford.edu, or visit ClinicalTrials.gov. At ClinicalTrials.gov, the identifier for the vaccine (ASP0892) trial is NCT02851277; the identifier for the antibody (AND020) trial is NCT02920021.
