US-based Allergen Research (ARC) has initiated its Phase IIb clinical trial for nut allergy oral immunotherapy (OIT) with characterised peanut allergen (CPNA).
The placebo-controlled trial is designed to assess 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.
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The company will carry out the Phase IIb trial at eight sites across the US, with participants aged 4-26.
Allergen CEO Bryan Walser said: "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 primary objective of the OIT programme is to provide a commercial product to children and young adults with peanut allergies for reduction of individual clinical reactivity to limited allergen exposure.
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Allergen also plans to build upon its peanut allergy OIT programme to develop OIT products for treatment across most major food allergies in the near future.
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By GlobalDataThe trial is financed by Longitude Capital with support from Food Allergy Research & Education (FARE).
FARE CEO John Lehr said the company has been encouraged by the promising results of its investments in OIT research.
"Currently, one in 13 children in the United States has a food allergy, an increase of 50% since the late 1990s," Lehr said.
"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."
During the trial, study investigators will be supplied with standardised doses of a cGMP formulation of CPNA to mix with food before ingestion.
According to the company, the trial protocol will follow a slow, steady up-dosing regimen to at least 20 times the amount of peanut protein that originally would have caused a reaction.
In the placebo arm of the trial, participants will be switched over to active once the trial reaches its primary endpoint, targeted at approximately six months.
Image: A peanut allergy warning. Photo: courtesy of Dan4th Nicholas from Cambridge, MA, US.
