INDIANAPOLIS – The results of a phase three clinical trial in peanut-allergic children ages 1 to 3 suggest an immunotherapy drug delivered via skin patch has the potential to help improve underlying food allergy by desensitizing the immune system to an allergen.
There are currently no treatment options approved by the United States Food and Drug Administration for peanut-allergic children under age 4. If approved, the immunotherapy drug, Viaskin Peanut, would provide an additional treatment option for patients for whom the standard of care—allergen avoidance and use of rescue medication—may not be enough. Phase three is the final clinical trial phase before a treatment may receive FDA approval.
Indiana University School of Medicine researcher Kirsten M. Kloepfer, MD, is a co-author and principal investigator on the study, which was recently published in the New England Journal of Medicine.
“We lack treatment options for toddlers with peanut allergy,” said Kloepfer, an associate professor of pediatrics at the school. “If additional analyses in these children continue to show improved tolerance to peanut, we may have a relatively easy way to desensitize peanut allergic toddlers. This would help alleviate parental fears that if a small crumb of peanut is accidentally ingested, their toddler will have a life-threatening allergic reaction.”
Kloepfer led the clinical trial’s study site in Indianapolis—one of 51 sites across Australia, Canada, Europe and the U.S., and the only site in Indiana. IU School of Medicine study site participants were patients at Riley Children’s Health.
The study, which was sponsored by biopharmaceutical company DBV Technologies, found that after one year of daily treatment with a patch containing 250 µg peanut protein (1/1000th of one peanut), Viaskin Peanut was statistically superior to placebo—a treatment that appears real but has no actual therapeutic benefit—in desensitizing participants to peanuts, increasing the peanut dose triggering their allergic symptoms. Additionally, a shift toward less severe food challenge reactions was seen following one year of treatment.
Similar to previous studies of Viaskin Peanut in children, the most common adverse events were local application site reactions, which decreased in frequency and severity over time. Low rates of treatment-related anaphylaxis and epinephrine use were observed.
Participants were able to wear the patch daily without restrictions around activities, for a sufficient duration over the course of the treatment period to induce desensitization.
Viaskin Peanut is currently under clinical investigation and is not yet approved by the FDA or any other regulatory agencies.
Kloepfer said IU School of Medicine researchers will soon begin enrolling children ages 4 to 7 in another Viaskin Peanut trial to determine how they will respond to the treatment. Those interested in enrolling their child in this study can contact Patrick Campbell at 317-278-7117.
About IU School of Medicine
IU School of Medicine is the largest medical school in the United States and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.