First clinical trial of a new IgE-adsorber in allergic asthma

A novel highly selective single-use IgE-immunoadsorber, IgEnio, has been developed using BM10, a non-anaphylactic fragment of a monoclonal anti-human IgE antibody. In a proof of concept study, IgEnio was used to deplete IgE from the plasma of patients suffering from allergic asthma. In a randomized open-label trial (NCT02096237) 15 highly allergic asthmatics with a total IgE of ≥300U/ml were included. Ten patients were randomly allocated to the treatment group, 5 to a control group. During 16 weeks, every treated patient had a total of 9 IgE-adsorptions: 3 in the 1 st , the 6 th and the 11 th week, respectively. Control visits were scheduled between the weeks of treatment and at the end of the study. Aims of the trial were (1) reduction of total IgE by ≥50% after the last treatment as compared to the beginning of the trial and (2) to demonstrate safety of the new IgE-adsorber. In addition, lung parameters and symptoms were recorded to trace clinical effects. All study participants completed the trial but one, who dropped out for personal reasons before first treatment. Irrespective of individual total-IgE levels (range 308-2518U/ml) IgE was reduced by 79% on average per treatment and by 86.2% (±5.1%) over the entire treatment period. Most adverse events possibly related to the investigational treatment concerned deviations of laboratory parameters and allergic reactions of the skin which are also observed in other immunoadsorption therapies. However, all adverse events were effectively medicated and IgE-adsorptions could be completed in all patients. Using IgEnio, a reliable and safe reduction of total-IgE was achieved, even for extremely elevated IgE-levels. Further studies will focus on clinical efficacy of IgE-adsorption.