Demonstrating proof of concept for an inhaled asthma biologic

Until now, biologics for treating severe bronchial asthma have been injected under the skin. The company Novartis has produced a new inhalable formulation of an antibody to target an alarmin (anti-TSLP antibodies) that is now being clinically tested by Fraunhofer ITEM scientists together with a network of German and Canadian test sites to determine its safety, tolerability and effectiveness. In the early development stage of this formulation, rather than measuring the direct effect to protect against exacerbations in patients with severe asthma, the inhaled allergen challenge model was used with patients with mild asthma as a proof of concept.

Overall, 28 test subjects at 10 test sites received treatment once daily with a dry powder inhaler for a period of 12 weeks. Three inhaled allergen challenges were administered before the start of the treatment and again six and twelve weeks afterward to measure the effectiveness of drug treatment in protecting against allergen-induced lung function decline. It was found that the treatment with the inhaled biologic is safe and well tolerated and effectively prevents lung function decline. The results were published in the European Respiratory Journal (Gauvreau, G. M. et al., 2023: DOI 10.1183/13993003.01193-2022).