Drug intelligence / Profile preview

Birch allergoid

Development stage
Unknown
Lead developer
Lofarma
Modality
Subcutaneous Immunotherapy → Allergy Immunotherapy → Therapeutic Vaccines → Vaccines & Immunotherapeutics, Sublingual Immunotherapy → Allergy Immunotherapy → Therapeutic Vaccines → Vaccines & Immunotherapeutics
Administration
Sublingual
01

Overview

Birch allergoid (brand name: LAIS Birch tablets) is a sublingual immunotherapy (SLIT) product developed by Lofarma. Its active ingredient is a carbamylated monomeric allergoid (CMA) derived from birch pollen, specifically targeting the immune response to birch tree pollen allergens (including the major birch pollen allergen Bet v 1). As an allergoid-based biologic/immunotherapy, it is classified as a modified allergen extract (biologic modality). It is indicated for the treatment of tree pollen-induced allergic rhinoconjunctivitis and mild controlled seasonal allergic asthma in adults. A Phase 3 clinical trial was completed in Italy evaluating the efficacy and safety of LAIS Birch tablets versus placebo in adults with tree pollen-induced allergic rhinoconjunctivitis, with or without mild controlled seasonal allergic asthma. The product is part of Lofarma's broader LAIS platform of carbamylated monomeric allergoid products, which also includes LAIS 2-tree allergoid tablets (covering birch and alder) and injectable formulations (LAIS-in).

Brand names
LAIS BirchLAIS Birch tablets
Other names
carbamylated monomeric birch pollen allergoidcarbamylated monomeric tree pollen dropsLAIS Birch-Alder tabletsLais Frühblüher sublingual dropsTree-pollen allergoid - Lofarma
02

Targets

PR-10 (Pathogenesis-related protein 10 homolog food allergens)Bet v 1-specific IgE bound to FcεRI on mast cells and basophils

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