Abstract: The present invention relates to an oral dosage form comprising gamma-aminobutyric acid (GABA) and pharmaceutically acceptable excipients, wherein 100% of the GABA is released within 0.25-5 hours in 0.01 M HCl at 37° C. in a USP dissolution apparatus 2. The invention further relates to specific dosage forms, methods for treatment of autoimmune diseases with the dosage form, as well as use of the dosage form in such methods.

Abstract: The present invention relates to an oral dosage form comprising gamma-aminobutyric acid (GABA) and pharmaceutically acceptable excipients, wherein 100% of the GABA is released within 0.25-5 hours in 0.01 M HCl at 37° C. in a USP dissolution apparatus 2. The invention further relates to specific dosage forms, methods for treatment of autoimmune diseases with the dosage form, as well as use of the dosage form in such methods.

Abstract: The present invention relates to methods for identifying patients a subject at risk of developing an autoimmune or inflammatory disorder, as well as methods of prevention of development of an autoimmune or inflammatory disorder, comprising administering GABA, or a GABA receptor agonist, to a subject so identified. The invention furthermore relates to methods for assessing a subject's susceptibility to treatment with gamma-aminobutyric acid (GABA) or a GABA receptor agonist, as well as biomarkers to be used in the assessment of the response of a GABA treatment.

Abstract: The invention relates to a method for assessing the efficacy of an immunotherapy comprising administration of GAD to a patient, comprising the following steps: measuring at least one of GADA IgG subclass distribution; GADA levels; distribution of cytokines secreted from lymphocytes; and lymphocyte proliferation in presence of GAD or CD3/CD28 beads; in a first blood, plasma or serum sample obtained from said patient at a first point in time and in a second blood, plasma or serum sample obtained from said patient at a later point in time; and comparing the so obtained measurements. The invention also relates to novel administration regimens of GAD in treatment or prevention of type 1 diabetes, that may include administration by injection into a lymph node, oral administration of vitamin D and/or an assessment of efficacy according to the above methodology followed by an adjustment of dosage and/or administration route based on said assessment.

Abstract: The present invention relates to methods for treatment or prevention of disorders caused influenced by dysfunction of ? cells by administering to said patient a compound selected from the group consisting of GABAA receptor agonists. The invention further relates to in vitro methods for finding potentially useful pharmaceutical compounds.

Abstract: The present invention relates to the use of at least two autoantigens specific to an autoimmune disease for treatment of said disease. The invention further relates to a method for treatment or prevention of an autoimmune disease, comprising administering to a subject such a pharmaceutical composition or administering to a subject at least two pharmaceutical compositions, each comprising at least one autoantigen which is not present in another such pharmaceutical composition, and which autoantigen is specific to an autoimmune disease.