Aimmune Therapeutics has started a Phase II trial of AR101 with adjunctive dupilumab for the treatment of patients with peanut allergies as part of a collaboration with Regeneron and Sanofi.
The trial intends to examine the efficacy and safety of dupilumab as adjunct to AR101, which is being developed by Aimmune as a biologic oral immunotherapy for desensitisation of patients with peanut allergy.
Dupilumab is Regeneron and Sanofi’s fully human monoclonal antibody that are designed to inhibit signaling of IL-4 and IL-13 cytokines, which are considered to be major drivers of type 2 inflammation.
Sponsored by Regeneron, the trial aims to recruit around 160 peanut-allergic patients between the age group of six-17 at 25 sites across the US.
As part of the trial, all the patients will be treated with AR101 and will be initially randomised in 2:1 ratio to receive dupilumab or placebo.
Dosing with dupilumab or placebo will take place in combination with AR101 throughout the AR101 up-dosing period.
The trial’s primary endpoint is to evaluate whether dupilumab, as adjunct to AR101 in a Characterized Oral Desensitization ImmunoTherapy (CODIT) regimen, versus placebo with AR101 in a CODIT regimen, improves desensitisation at the completion of up-dosing.
The endpoint will be defined as an increase in the proportion of subjects who pass a double-blind, placebo-controlled food challenge (DBPCFC) with a single-highest tolerated dose of 1,000mg of peanut protein.
Additional DBPCFCs will be determined after a 24-week maintenance period and at the end of a 12-week, treatment-free follow-up period.
Regeneron president and chief scientific officer George Yancopoulos said: “The incidence of food allergy continues to rise and with it the risk of life-threatening allergic reactions.
“Dupilumab targets the IL-4/IL-13 signaling pathway, which is a critical driver of allergic inflammation and which we believe regulates the balance between allergic antibodies and the protective antibodies generated during desensitisation.
“After receiving its first FDA approval, dupilumab is being explored in a wide range of diseases that we believe share a common pathway, such as asthma, nasal polyps and various allergies.”