Therapy Areas: AIDS & HIV
Aimmune Therapeutics Starts Phase 2 Study with Regeneron and Sanofi of AR101 with Adjunctive Dupilumab in Peanut-Allergic Patients
15 October 2018 - - US-based biopharmaceutical company Aimmune Therapeutics, Inc. (NASDAQ: AIMT) has initiated a phase 2 study, with Regeneron and Sanofi, of AR101 with adjunctive dupilumab in peanut-allergic patients, the company said.

AR101 is Aimmune's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy, and dupilumab is Regeneron and Sanofi's fully human monoclonal antibody that inhibits signaling of IL-4 and IL-13 cytokines, which are believed to be major drivers of type 2 inflammation.

Aimmune is providing clinical supply of AR101, as well as food challenge materials, for the Regeneron-sponsored study.

The phase 2 clinical trial is designed to evaluate the efficacy and safety of dupilumab as adjunct to AR101 and is expected to enroll approximately 160 peanut-allergic patients ages 6–17 at 25 sites across the United States.

All participants will receive AR101 and will be initially randomized 2: 1 to receive dupilumab or placebo.

Dosing with dupilumab or placebo will take place in combination with AR101 treatment through the AR101 up-dosing period.

The primary objective of the trial is to assess whether dupilumab as adjunct to AR101 in a Characterized Oral Desensitization ImmunoTherapy (CODIT) regimen, compared to placebo with AR101 in a CODIT regimen, improves desensitisation at the completion of up-dosing, defined as an increase in the proportion of participants who pass a double-blind, placebo-controlled food challenge (DBPCFC) with a single-highest tolerated dose of 1,000 mg of peanut protein (equivalent to a cumulative amount of 2,044 mg of peanut protein).

There will be additional DBPCFCs after a 24-week maintenance period (for which the AR101-dupilumab patients will be re-randomised 1: 1 to AR101-dupilumab or AR101-placebo) and at the end of a 12-week, treatment-free follow-up period.

In Aimmune's pivotal phase 3 PALISADE trial, AR101 demonstrated an encouraging tolerability and safety profile over the course of approximately one year of treatment, and approximately 80% of AR101 patients ages 4–17 completed the study.

At the study's conclusion, more than 60% of those completers tolerated the highest dose of the exit food challenge (1,000 mg / 2,043 mg cumulative).

The PALISADE trial met its primary and key secondary efficacy endpoints in the pre-specified primary analysis of the 4-17 age cohort and greatly exceeded the pre-specified 15% lower-bound of the 95% confidence interval of the difference between treatment arms at the primary endpoint.

Aimmune plans to submit a US regulatory filing for marketing approval of AR101 by the end of 2018.

Dupilumab (marketed under the brand name Dupixent) is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

Potential uses beyond the indication approved by the US Food and Drug Administration and European Medicines Agency are investigational, and no regulatory authority has evaluated their safety and efficacy.

Aimmune Therapeutics is a biopharmaceutical company developing treatments for life-threatening food allergies.

The company's Characterized Oral Desensitization ImmunoTherapy (CODIT) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitising patients with defined, precise amounts of key allergens.

Aimmune's first investigational biologic product using CODIT, AR101 for the treatment of peanut allergy, has received the FDA's Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4–17 years of age.

The company said it plans to submit regulatory filings for marketing approval of AR101 in the United States and Europe based on data from the pivotal Phase 3 PALISADE clinical trial of AR101, which in 4–17-year-old subjects met its primary and key secondary endpoints, and additional ongoing and completed AR101 clinical trials.