The first UK patient has been enrolled in an EU peanut allergy trial
Several children and teenagers living in the UK afflicted with a peanut allergy are amongst the first to enrol in an EU wide study to investigative a new oral immunotherapy for the allergy.
The Phase III ARTEMIS trial assess the safety and effectiveness of Aimmune Therapeutics’ oral biologic AR101 in desensitising patients aged 4 to 17 years to the protein found in peanuts, to protect them from experiencing life-threatening reactions upon accidental exposure.
Approximately 250,000 children in the UK are believed to have a peanut allergy. For 80% of those it will be a life-long condition and prevalence is growing. Which highlights the importance of gaining a better understanding of peanut allergy in the hopes of helping to fulfil the currently unmet requirements.
The firm said it aims to expand the data available on the efficacy profile of AR101 by exploring a higher level of protection, after a shorter treatment period, within a broader group of patients than in the current ongoing Phase III Study, PALISADE, which is investigating the safety 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 have already 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% of patients were successfully desensitised to a single 600mg dose of peanut protein, equivalent to about two peanuts. Most adverse events observed in the trials were mild and consistent with exposure to a food allergen, the firm noted, though around 20% of patients were unable to complete the six-months of up-dosing primarily 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.
Source – PharmaTimes