Development and evaluation of a sublingual tablet based on recombinant Bet v 1 in birch pollen‐allergic patients

• DOI: 10.1111/all.12622
• Publication Date: 2015-04-02T22:26:28Z
• Authors: E. Nony; J. Bouley; M. Le Mignon; P. Lemoine; K. Jain; S. Horiot; L. Mascarell; M. Pallardy; R. Vincentelli; P. Leone; A. Roussel; T. Batard; K. Abiteboul; B. Robin; O. de Beaumont; M. Arvidsson; S. Rak; P. Moingeon
• Keywords: Sublingual administration; Sublingual Immunotherapy; Slit

Sublingual immunotherapy (SLIT) applied to type I respiratory allergies is commonly performed with natural allergen extracts. Herein, we developed a sublingual tablet made of pharmaceutical-grade recombinant Bet v 1.0101 (rBet 1) and investigated its clinical safety efficacy in birch pollen (BP)-allergic patients.Following expression Escherichia coli purification, rBet 1 was characterized using chromatography, capillary electrophoresis, circular dichroism, mass spectrometry crystallography. Safety formulated as were assessed multicentre, double-blind, placebo-controlled study conducted 483 patients BP-induced rhinoconjunctivitis.In-depth characterization confirmed the intact product structure high purity GMP-grade 1. The crystal resolved at 1.2 Å documented conformation molecule. Native or oxidized forms did not induce production any proinflammatory cytokine by blood dendritic cells mononuclear cells. tablets well tolerated patients, consistent known profile SLIT. average adjusted symptom scores significantly decreased relative placebo receiving once daily for 5 months tablets, mean difference 17.0-17.7% group treated (P < 0.025), without influence dose range (12.5-50 μg) tested.Recombinant has been produced well-characterized biological drug. administration safe efficacious BP allergic rhinoconjunctivitis.