Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical.

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Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial J. Andrew Bird, MD, Jonathan M. Spergel, MD, PhD, Stacie M. Jones, MD, Rima Rachid, MD, Amal H. Assa'ad, MD, Julie Wang, MD, Stephanie A. Leonard, MD, Susan S. Laubach, MD, Edwin H. Kim, MD, Brian P. Vickery, MD, Benjamin P. Davis, MD, PhD, Jennifer Heimall, MD, Antonella Cianferoni, MD, PhD, Andrew J. MacGinnitie, MD, PhD, Elena Crestani, MD, A. Wesley Burks, MD The Journal of Allergy and Clinical Immunology: In Practice Volume 6, Issue 2, Pages 476-485.e3 (March 2018) DOI: 10.1016/j.jaip.2017.09.016 Copyright © 2017 The Authors Terms and Conditions

Figure 1 ARC001 enrollment and disposition. AE, Adverse event; DBPCFC, double-blind, placebo-controlled food challenge; GI, gastrointestinal; ITT, intent-to-treat; SAE, serious adverse event. The Journal of Allergy and Clinical Immunology: In Practice 2018 6, 476-485.e3DOI: (10.1016/j.jaip.2017.09.016) Copyright © 2017 The Authors Terms and Conditions

Figure 2 Clinical response to AR101. The percentage of subjects receiving AR101 or placebo who were able to successfully tolerate the indicated dose at the exit DBPCFC is listed on the y-axis for the primary endpoint (443 mg cumulative of peanut protein or the 300 mg dose level) and the top challenge dose tested (1043 mg cumulative of peanut protein or the 600 mg dose level). A, Results for the ITT population, where all subjects withdrawing before the exit DBPCFC are considered treatment failures. B, Results for the completer population who undertook the exit DBPCFC. DBPCFC, Double-blind, placebo-controlled food challenge; ITT, intent-to-treat. The Journal of Allergy and Clinical Immunology: In Practice 2018 6, 476-485.e3DOI: (10.1016/j.jaip.2017.09.016) Copyright © 2017 The Authors Terms and Conditions

Figure 3 Probability of tolerating each exit DBPCFC dose or higher. Plots of the probability of subjects in the ITT population tolerating each challenge dose or higher at the exit DBPCFC (y-axis) as a function of challenge dose administered (x-axis). Green line: AR101 group; gray line: placebo group. DBPCFC, Double-blind, placebo-controlled food challenge; ITT, intent-to-treat. The Journal of Allergy and Clinical Immunology: In Practice 2018 6, 476-485.e3DOI: (10.1016/j.jaip.2017.09.016) Copyright © 2017 The Authors Terms and Conditions

Figure 4 Symptom severity at each exit DBPCFC dose level. The proportion of subjects from the placebo group (A) and AR101 group (B) in the completer population (without imputation) experiencing the indicated severity of allergic reactions at each dose of peanut protein of the exit DBPCFC. Note that in the placebo group the number of subjects undergoing testing at a specific challenge dose decreases as the challenge dose level increases. This is because subjects who fail to tolerate a given challenge dose with no or only mild symptoms were prohibited from advancing to the next challenge dose level. Panels (C) and (D) show the results for all placebo and AR101 subjects, respectively, who entered the exit DBPCFC with the maximum symptom severity carried forward (MSSCF). In the MSSCF representation, the grade of the most severe symptom elicited at any administered challenge dose was used as the imputation value for any subsequent dose that was either not given or resulted in a less severe symptom score. As values for subjects no longer eligible to progress in the DBPCFC were imputed, the number of subjects at each challenge dose level remains constant. DBPCFC, Double-blind, placebo-controlled food challenge. The Journal of Allergy and Clinical Immunology: In Practice 2018 6, 476-485.e3DOI: (10.1016/j.jaip.2017.09.016) Copyright © 2017 The Authors Terms and Conditions

Figure 5 Immunomodulatory changes during therapy. SPT mean wheal diameter (A), peanut-specific IgG4 geometric mean (B), and peanut-specific IgE/IgG4 ratio (C) at screening and exit visits in the treatment and placebo ITT populations. CI, Confidence interval; ITT, intent-to-treat. The Journal of Allergy and Clinical Immunology: In Practice 2018 6, 476-485.e3DOI: (10.1016/j.jaip.2017.09.016) Copyright © 2017 The Authors Terms and Conditions

Figure E1 ARC001 study schematic. DBPCFC, Double-blind, placebo-controlled food challenge; OIT, oral immunotherapy. The Journal of Allergy and Clinical Immunology: In Practice 2018 6, 476-485.e3DOI: (10.1016/j.jaip.2017.09.016) Copyright © 2017 The Authors Terms and Conditions