AnaptysBio says Phase 2 imsidolimab trial did not meet endpoints

AnaptysBio announced that top-line data from its Phase 2 clinical trial of imsidolimab for the treatment of moderate-to-severe acne, also known as the ACORN trial, did not demonstrate efficacy over placebo on primary or secondary endpoints. Top-line data from the ACORN trial are as follows: mean baseline facial inflammatory lesion counts for the imsidolimab high dose arm, the imsidolimab low dose arm and placebo arm were 30, 29 and 27, respectively. Each arm had an average baseline facial investigator global assessment score of 3.1. Patients were on average 20 years of age and 65% were female. The primary endpoint of facial inflammatory lesion count change from baseline at week 12 was -6.8 (-27%) for the imsidolimab high dose arm, -7.4 (-21%) for the imsidolimab low dose arm and -9.6 (-38%) for the placebo arm. Facial IGA of clear or almost clear with at least a 2-point decrease from baseline, a secondary endpoint, was achieved at week 12 by 12% of patients in the imsidolimab high dose arm, 0% of the patients in the imsidolimab low dose arm and 14% of patients in the placebo arm.