12 January - 20 June 2016

Drug shown to have promise in treatment for peanut allergy

A study published in New England Journal of Medicine has investigated if a drug called AR101 developed by Aimmune Therapeutics, but yet to be approved, could be used to treat people with severe peanut allergies, so that they are able to tolerate small doses of peanut protein.

A study published in New England Journal of Medicine has investigated if a drug called AR101 developed by Aimmune Therapeutics, but yet to be approved, could be used to treat people with severe peanut allergies, so that they are able to tolerate small doses of peanut protein. The scientists report that AR101 is a peanut-derived investigational biologic oral immunotherapy drug that “delivers a target daily maintenance dose of 300 mg of peanut protein”.

Currently there is no approved treatment for peanut allergy, and patients are adverse to strictly eliminate them from the diet.  Previous research have suggested that oral immunotherapy is a potential strategy by inducing desensitisation.

The double blind randomised controlled phase 3 trial, named PALISADE, conducted by a number of international institutions including Emory University in the US and University College, Cork, Ireland, involved over 500 participants with severe peanut allergy.  The participants were aged between 4 and 55 years however most were 4 to 17 years old.

 The trial was carried out at 66 sites in 10 countries in North America and Europe.  The participants were randomly split into two groups, with one group (two third of participants) receiving the AR101 drug and the other group (a third of participants) receiving a placebo. 

On day one the participants participated in an initial dose-escalation phase. The dosage of the drug was increased from 0.5 mg to 6 mg throughout the course of a day.  Then at every two weeks, dosage was increased to 300 mg over a period of 6 months.  During a maintenance phase of 6 months, the participants received a constant dose of 300 mg peanut protein. 

After 12 months (exit food challenge) the participants, whilst under close supervision, increased their peanut dosage from firstly 300 mg then 600mg and finally 1000 mg, to see how much could be tolerated. The scientists were interested if the group who consumed the AR101 drug were able to tolerated higher levels of peanut protein compared to those who consumed the placebo.  They report that 67% of the participants in the AR101 were able to tolerate a dose of 600 mg or more without serious symptoms, whilst the only 4% in the placebo group could tolerate of dose of 600 mg of peanut protein.  The scientist report that “during the exit food challenge, the maximum severity of symptoms were moderate in 35% of the participants in the active drug group and 59% of those in the placebo group and severe in 5% and 11% respectively. Compared to the placebo group, 10% of the participants in the active drug group received rescue epinephrine during the exit food challenges, as compared with 53% of those in the placebo group.

The study concludes by stating that their study “showed that AR101 was an immunomodulatory treatment that resulted in desensitisation in children and adolescents who were highly allergic to peanut.  No significant effect was found in participants 18 to 55 years of age.”

RSSL can provide you with a complete food allergen management solution. We provide a comprehensive range of analysistraining and food allergen consultancy services to help you control and manage allergens within food manufacturing and retailing. To find out more please contact Customer Services telephone 0118 918 4076 or e-mail enquiries@rssl.com

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