Roche has reported findings from Stage I of the Phase III OUtMATCH study of the immunoglobulin E (IgE)-targeting antibody Xolair (omalizumab) in people with multiple food allergies.
Sponsored by the US National Institutes of Health (NIH), the three-stage, multicentre, randomised, placebo-controlled, double-blind trial is funded by the NIH unit National Institute of Allergy and Infectious Diseases (NIAID).
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It assessed the efficacy and safety of 180 subjects aged one to 55 years who were allergic to peanuts and at least two other common foods at ten US sites.
Participants in stage one were assigned to receive placebo or Xolair injections every two or four weeks for 16 to 20 weeks.
The trial’s primary endpoint was the ability to consume at least 600mg of peanut protein without experiencing moderate to severe allergic reactions.
Results indicated that Xolair treatment enhanced the threshold for triggering moderate to severe allergic reactions to peanuts and other foods in people as young as one year.
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By GlobalDataSafety findings aligned with Xolair’s established safety profile from prior trials and approved indications.
The development comes after the US Food and Drug Administration (FDA) approved the expanded use of Xolair for IgE-mediated food allergies based on these findings.
Furthermore, a higher proportion of Xolair-treated patients could consume the target amounts of peanut, milk, egg, and cashew protein compared to the placebo group.
Additionally, Xolair recipients tolerated higher amounts of walnut, hazelnut, and wheat protein.
Adverse events were similar between the Xolair and placebo groups, with injection site reactions being the most common in Xolair-treated children and adolescents.
An open-label extension for 38 children who continued the therapy for 24-28 weeks showed that the ability to consume allergenic foods without severe reactions was maintained.
Roche Global Product Development head and chief medical officer Levi Garraway said: “The Phase III OUtMATCH results represent a major advance and reinforce our commitment to addressing critical gaps in care for conditions like food allergy.
“Now recently FDA-approved, Xolair provides a new way to help manage food allergies for children and adults who live with the constant fear of life-threatening allergic reactions.”
Roche reported the 72-week data from two Phase III trials, BALATON and COMINO, in which its bispecific antibody Vabysmo (faricimab) demonstrated to be effective in treating macular oedema due to branch and central retinal vein occlusion.
