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Methods (Dog) Ragweed (RW)-sensitized dogs (n=5) were treated with VTX-378 (100, 500 or 1000 μg/dog), given ~ 24 hours prior to RW challenge. Two VTX-378 pretreatments of 250 or 1000 μg/dog, spaced either 3, 4 or 7 days apart were also evaluated. Changes in nasal cavity volumes (congestion) were determined by acoustic rhinometry. (Human) Subsequently, a randomized, double blind, placebo-controlled study was conducted in-season, and enrolled 80 adults with confirmed atopy to grass pollen. Two dosing regimens were compared to placebo: ascending dose (GrpA; 25, 50, 75, 100 μg) and fixed dose (GrpB; 62.5 μg x 4 doses). Subjects were dosed on Days 1, 8, 15, and 22 with VTX-1463. On day 24, subjects underwent grass allergen exposure. The primary endpoints were the average change over 6 hours of allergen exposure in Total Nasal Symptom Score (TNSS; sum of scores for nasal congestion, itching, sneezing and rhinorrhea) and Active Anterior Rhinometry (ARR).

A novel TLR-8 agonist attenuates nasal symptoms/congestion in both dog and human allergen challenge studies