Aimmune Therapeutics, Inc. has shared its positive findings from the Phase 3 POSEIDON (Peanut Oral immunotherapy Study of Early Intervention for DesensitisatiON) study of Palforzia.
The results were presented at the American College of Allergy, Asthma & Immunology 2022 Annual Scientific Meeting in Louisville, Kentucky on November 12, 2022.
The study met the primary outcomes, with almost three-quarters of patients tolerating at least a 600mg single dose or 1,000mg single dose of peanut protein (73.5% & 68.4% respectively). In addition, 61.2% of patients also tolerated the highest dose level of 2,000mg.
There were no Palforzia-related serious or severe adverse events, and systemic allergic reactions due to any cause were similar between Palforzia and placebo-treated patients. Treatment-related systemic allergic reactions occurred in 2% of Palforzia-treated patients.
“In my treatment of children aged 4 through 17 with Palforzia, I have seen firsthand the benefits of this therapy,” said George du Toit, M.B., B.Ch., Professor of Paediatric Allergy at Evelina London Children’s Hospital, Guy’s and St Thomas’ NHS Foundation Trust, King’s College London and study investigator in Palforzia clinical trials.
“I am now encouraged by these promising results in younger children, which show that the majority of study participants tolerated a dose of 600mg of peanut protein – the equivalent of two peanut kernels – after 12 months of treatment, and no severe systemic allergic reactions and only infrequent mild-moderate systemic allergic reactions reported among Palforzia-treated participants.”
Aimmune plans to submit the full POSEIDON study results for publication in a peer-reviewed journal and submit these study results to the US Food and Drug Administration (FDA) in the first half of 2023 to support the use of Palforzia in appropriate peanut-allergic children aged 1-3 years, subject to review and approval by FDA. Palforzia is currently not approved for children aged 1 to 3 in the UK on the NHS.
For more information on immunotherapy, please see our Allergen Immunotherapy Factsheet.
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