Children and adolescents in the UK with peanut allergy are among the first to enrol in a Europe-wide study investigating a new oral immunotherapy for the condition.
The Phase III ARTEMIS trial is assessing the safety and effectiveness of Aimmune Therapeutics’ oral biologic AR101 in desensitising patients aged 4 to 17 years to peanut protein, in order to protect them from experiencing life-threatening reactions upon accidental exposure to peanut.
Around 250,000 children in the UK are thought to have a peanut allergy. For 80 percent of patients it will be a life-long condition and its prevalence is growing, highlighting the importance of garnering a better understanding of peanut allergy in the hope of helping to fulfil the unmet need.
The firm said it intends to expand the data available on the efficacy profile of AR101 by exploring a higher level of protection, after a shorter treatment period, in a broader group of patients than in the current ongoing Phase III Study, PALISADE, which is investigating the safer and efficacy of the treatment in more than 500 people aged 4-55 years living with peanut allergy.
The first of the planned 160 subjects for the Artemis trial has now been enrolled at the Evelina London Children’s Hospital, the specialist paediatrics clinic at Guy’s & St Thomas’s Hospital in London, with additional UK sites and others in western Europe set to follow.
The study builds on Phase II trials, in which 90 percent of patients were successfully desensitised to a single 600mg dose of peanut protein, equivalent to about two peanuts. The majority of adverse events observed in the trials were mild and consistent with exposure to a food allergen, the firm noted, though around 20 percent of patients were unable to complete the six-months of up-dosing mainly due to gastrointestinal adverse events.
“It is encouraging to see the commitment from Aimmune to researching a solution aimed at protecting people from the effects of peanut allergy. We welcome new treatments as peanut allergy can be fatal and living with the condition can cause a lot of anxiety,” commented Lynne Regent, chief executive of leading UK allergy charity, Anaphylaxis Campaign.