Allergen Research Corporation Initiates Phase 2b Clinical Trial for Peanut Allergy Oral Immunotherapy (OIT)
Study Marks Progress toward Making Gains from OIT Research Clinically Available for Food Allergy Treatment
SAN MATEO, Calif., February 27, 2014— Allergen Research Corporation (ARC), a privately held company developing desensitization treatment protocols and products for food allergies, today announced the start of its Phase 2b clinical trial for peanut allergy oral immunotherapy (OIT) with characterized peanut allergen (CPNA). The trial seeks to establish the safety and efficacy of OIT and CPNA as a prescribed treatment for individuals with peanut allergy to follow under the care of a trained and certified allergist.
“Research has shown that OIT is effective for a significant percentage of patients, and this trial is an important step toward making a standardized treatment product and protocol available in the clinic,” said ARC CEO Bryan Walser, MD. “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.”
The ultimate goal of ARC’s peanut allergy OIT program is to offer a commercial product to children and young adults with peanut allergies for reduction of individual clinical reactivity to limited allergen exposure. Longer term, ARC plans to build upon its peanut allergy OIT program to develop OIT products for treatment across most major food allergies. Financing to conduct the Phase 2b trial was led by Longitude Capital and included support from Food Allergy Research & Education (FARE), the nation’s leading nonprofit focused on food allergies.
“FARE has been encouraged by the promising results of our investments in OIT research, and we are eager to see that research developed into therapies that can protect as many people with food allergies as possible,” said FARE CEO John L. Lehr. “Currently, one in 13 children in the United States has a food allergy, an increase of 50 percent since the late 1990s. As we continue to make strategic investments in research to address this emerging epidemic, we are pleased to be supporting progress toward commercially available treatments.”
ARC will conduct the placebo-controlled Phase 2b trial at eight sites across the United States, with participants of ages 4-26. The company will supply trial investigators with standardized doses of a cGMP (current good manufacturing practices) formulation of CPNA, a peanut protein sourced from a domestic manufacturer, intended for mixing with food prior to ingestion. The trial protocol will follow a slow, steady up-dosing regimen to at least 20 times (and more usually up to 200 times) the amount of peanut protein that originally would have caused a reaction. Participants in the placebo arm of the study will be switched over to active once the study reaches its primary endpoint, targeted at approximately six months.
About Allergen Research Corporation
Allergen Research Corporation (ARC), founded in 2011, develops treatments to protect children with food allergies from the life-threatening consequences of accidental exposure. ARC’s work, which builds on more than a decade of groundbreaking research in oral immunotherapy by the company’s academic and non-profit collaborators, aims to establish allergen desensitization treatment protocols and supply treatment products for clinical use. The company’s lead product, now in Phase 2b development, is a standardized formulated peanut protein designed for gradual, controlled up-dosing and ongoing maintenance dosing to dramatically increase the threshold at which patients show an allergic reaction to peanuts. This and subsequent ARC products would address an urgent and growing unmet medical need: while the prevalence and social impact of food allergies continues to increase, current treatment options are limited to emergency measures post-reaction. For more information, please visit www.allergenresearch.com.