Safety and efficacy comparison : ARTEMIS and PALISADE phase 3 studies of AR101 in peanut allergy

Abstract

AR101, an investigational oral biologic drug for peanut oral immunotherapy, was studied in PALISADE and ARTEMIS phase 3 trials. Efficacy and safety are compared. Subjects demonstrated clinical history of peanut allergy; peanut-specific immunoglobulin E ≥ 0.35 kUA/L and/or skin-prick test ≥ 3 mm; reacted to ≤ 100 mg (PALISADE)/≤ 300 mg peanut protein (ARTEMIS) at screening double-blind, placebo-controlled food challenge (DBPCFC). After dose escalation to 300 mg/day (6 months), 300 mg/day dosing continued (PALISADE, 6 months; ARTEMIS, 3 months). Results are reported in subjects 4-17-years-old (intention-to-treat/safety populations). A total of 496 PALISADE (AR101 n = 372, placebo n = 124) and 175 ARTEMIS ( n = 132, n = 43) subjects were treated. Ability to tolerate 300 mg, 600 mg or 1000 mg peanut protein at exit DBPCFC was similar (PALISADE vs ARTEMIS; AR101 : 76.6% vs 73.5%, 67.2% vs 68.2%, 50.3% vs 58.3%; placebo : 8.1% vs 16.3%, 4.0% vs 9.3%, 2.4% vs 2.3%). Most treatment-emergent adverse events (TEAEs) were mild/moderate (AR101, placebo : PALISADE 94.4%, 94.4%; ARTEMIS 97.7%, 97.7%); frequency decreased from dose-escalation to 300 mg/day dosing (X). For dose-escalation in-clinic TEAEs, range of median times to symptom onset following ingestion and times from first symptom onset to last symptom resolution were similar (AR101, placebo: PALISADE onset 4.0–5.5 min, 8.0–38.5 min; resolution 16.0–32.5 min, 15.0–38.0 min; ARTEMIS onset 2.0–10.0 min, 1.5–15.0 min; resolution 14.0–47.8 min, 7.0–85.0 min) ( Fig. 1 ). AR101 efficacy and safety results are consistent across trials despite different entry criteria. Most TEAEs were mild/moderate and transient. AR101 has a readily manageable safety profile with high desensitization rates possible as early as 3 months after 300 mg/day dosing.