Part one will enrol around 100 subjects with at least one food allergy: egg, milk, peanut, cashew or walnut. Credit: Chokniti-Studio / Shutterstock.com.

RAPT Therapeutics has commenced the prestIgE Phase IIb trial of ozureprubart (previously RPT904), assessing its potential in patients with IgE-mediated food allergies.

The placebo-controlled, randomised, double-blind study will cover 30 sites across Australia, Canada and the US, and aims to evaluate the safety and efficacy of ozureprubart as monotherapy.

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It will include ozureprubart’s two treatment regimens, dosing every eight weeks or 12 weeks subcutaneously, with an initial loading dose at week two, against placebo, in a 2:2:1 ratio.

Part one will enrol around 100 subjects with at least one food allergy involving cashew, egg, milk, peanut, or walnut. They will be treated for 24 weeks.

The trial’s primary endpoint is the proportion of subjects meeting a specified threshold at a double-blind, placebo-controlled, oral food challenge (DBPCFC) at week 24.

Part two continues treatment in the ozureprubart arms for another 24 weeks; anyone previously on placebo will be re-randomised to this treatment either every eight weeks or 12 weeks.

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All subjects will undergo a further oral food challenge at week 48, followed by a 16-week safety observation period.

RAPT Therapeutics president and CEO Brian Wong said: “Food allergies are a large and growing problem for millions of patients worldwide. Initiating this trial is a significant milestone that reflects our strong execution, the validity of the early preclinical and clinical data generated by our partner, Jeyou, in China and our mission to provide patients with an improved anti-IgE therapy.

“We look forward to working with leading food allergists in the US, Canada and Australia to advance development of ozureprubart.”

Ozureprubart is an anti-IgE monoclonal antibody, designed to block free and cell-bound immunoglobulin E.

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