The placebo-controlled trial is designed to evaluate the safety and efficacy of OIT and CPNA as a prescribed treatment for patients with peanut allergy to follow under the care of a trained and certified allergist.
Participants aged 4-26 will be enrolled in the Phase IIb trial, which will be carried out at eight sites across the US.
Allergen CEO Bryan Walser said research has shown that OIT is effective for a significant percentage of patients, and the trial is an important step toward making a standardized treatment product and protocol available in the clinic.
"We hope to firmly establish that individuals with food allergies can safely utilize an OIT product to protect them from accidental exposure to their food allergens, both by diminishing the severity of their response and increasing the amount of allergen it takes to cause a reaction," Walser said.
Primary objective of the OIT program is to provide a commercial product to children and young adults with peanut allergies for reduction of individual clinical reactivity to limited allergen exposure.
The company also plans to build upon its peanut allergy OIT program to develop OIT products for treatment across most major food allergies in the near future.
The Phase IIb trial is financed by Longitude Capital with support from Food Allergy Research & Education (FARE).