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- W2148936839 abstract "RATIONALE: Toll-like receptors (TLRs) have been shown to modulate allergic immune responses. The safety and efficacy of VTX-1463_a novel, small-molecule, TLR8 agonist given once weekly intranasally_was assessed in allergic rhinitis (AR) subjects exposed to allergen in the Vienna Challenge Chamber (VCC). METHODS: This 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; 25mcg, 50mcg, 75mcg, 100mcg) and fixed dose (GrpB; 62.5mcg x 4 doses). Subjects were dosed on Days 1, 8, 15 and 22. On Day 24, subjects underwent grass allergen exposure in the VCC, a validated setting for assessing the efficacy of anti-allergic treatment. The primary efficacy endpoints were the average change over 6 hours of allergen exposure in Total Nasal Symptom Score (TNSS; the sum of scores for nasal congestion, itching, sneezing and rhinorrhea) and Active Anterior Rhinomanometry (AAR). Adverse event data were collected for all subjects. RESULTS: Subjects in the overall efficacy population (n=76) who were treated with VTX-1463 and underwent allergen challenge had significantly improved TNSS compared to placebo (p=0.012). This benefit was observed in both GrpA (p=0.008) and GrpB (p=0.012). AAR trended towards a benefit in both treatment groups, but was not statistically significant. VTX-1463 was generally well tolerated. CONCLUSIONS: Four doses of VTX-1463 conferred statistically significant improvement in TNSS compared to placebo. This TLR8 agonist may represent a novel, weekly-administered treatment for AR." @default.
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- W2148936839 date "2011-02-01" @default.
- W2148936839 modified "2023-10-16" @default.
- W2148936839 title "Intranasal Toll-like Receptor 8 Agonist (VTX-1463) Significantly Improves Symptoms of Allergic Rhinitis in a Randomized, Placebo-Controlled Trial" @default.
- W2148936839 doi "https://doi.org/10.1016/j.jaci.2010.12.790" @default.
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