California based biotech company, Aimmune, has presented strong phase 3 trial data for its peanut allergy treatment, AR101.
The 12-month study, which enrolled nearly 500 children who are intolerant to peanut protein showed promising results. Each child was randomized to receive AR101 or placebo. After a 22-week dose escalation phase, participants continued to take 300mg a day of peanut flour AR101 or placebo until the end of the study.
More than 2/3 of the patients on AR101 tolerated 600mg (about two peanuts or a small bite of a peanut butter sandwich) or more of peanut protein compared to only 4% in the control group.
There are, however, some concerns with the safety data as about one-fifth of the participants dropped out of the study siting adverse events such as GI issues and systemic hypersensitivity as the reason for leaving.
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