Date: 2017-10-16
Type of information: Clinical research agreement
Compound: AR101 and dupilumab
Company: Aimmune Therapeutics (USA - CA) Regeneron Pharmaceuticals (USA - NY) Sanofi (France)
Therapeutic area: Allergic diseases
Type agreement: clinical research
Action mechanism:
- immunotherapy product/monoclonal antibody. . AR101 is part of Aimmune Therapeutics’ approach to treating food allergies using its characterized oral desensitization immunotherapy, or CODIT™, system. The CODIT system leverages extensive independent scientific research on oral immunotherapy, or OIT, demonstrating that food allergy patients can be desensitized to exposure to food allergens by being administered well-defined, gradually increasing doses of the allergen over a period of months. Aimmune Therapeutics’ CODIT system is designed to precisely control the amount of allergen administered and follow a systematic dosing regimen that begins with very low doses of the allergen. Once a patient attains desensitization to a clinically meaningful level of food allergen, the patient continues to take a daily maintenance dose of the CODIT system product in order to maintain such desensitization.
- Dupilumab is a fully-human monoclonal antibody directed against the IL-4 receptor alpha subunit, which blocks signaling from both IL-4 and IL-13. IL-4 and IL-13 are key cytokines that are required for the initiation and maintenance of the Th2 (Type 2 helper T-cell) immune response, which is believed to be a critical pathway in allergic inflammation. Dupilumab was created using Regeneron's pioneering VelocImmune® technology and is being co-developed with Sanofi in atopic dermatitis, asthma and chronic sinusitis with nasal polyps.
Disease: peanut allergy
Details:
- • On October 16, 2017, Aimmune Therapeutics announced a clinical collaboration with Regeneron and its strategic alliance collaborator Sanofi to study AR101 treatment with adjunctive dupilumab in peanut-allergic patients in a Phase 2 clinical trial. Regeneron will sponsor the trial, with Aimmune to provide clinical supply of AR101 and food challenge materials.
- The planned Phase 2 clinical trial is expected to begin in 2018. It will explore desensitization with AR101 treatment with adjunctive dupilumab (or placebo) in peanut-allergic patients, with a proposed primary endpoint of tolerating a certain dose of peanut protein in a double-blind, placebo-controlled food challenge (DBPCFC) that will include doses matching and exceeding those being tested in current AR101 studies. The study also includes a proposed exploration of sustained unresponsiveness after discontinuation of therapy in another DBPCFC. Sustained unresponsiveness is achieved when, after a break in treatment, peanut-allergic patients are able to tolerate a defined amount of peanut protein with no more than mild allergic symptoms. This has been recently demonstrated with low-dose oral immunotherapy in very young children.
- The clinical collaboration will include the formation of an Aimmune–Regeneron/Sanofi Joint Development Committee.
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