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ALX-0171: Safety and Therapeutic Potential of an Inhaled Anti-RSV Nanobody

De Bruyn S, De Smedt T, Allosery K, Crabbe P, De Brabandere V, Detalle L, Mortier K, Schoolmeester A, Wouters H, Stöhr T, Depla E.

RDD Europe 2015. Volume 1, 2015: 37-48.

Abstract:

ALX-0171 Nanobody® is a therapeutic protein currently being developed for the treatment of respiratory syncytial virus (RSV) lower respiratory tract infection in young children. Inhaled delivery of ALX-0171 was initially evaluated in a Phase I, first-in-human clinical study in healthy adults. The study consisted of a single ascending dose and a multiple dose part, evaluating doses in the range of 2.1 to 210 mg. Sixty subjects were randomly assigned to receive either ALX-0171 or placebo via inhalation, delivered using a breath-actuated vibrating mesh nebulizer. ALX-0171 was well-tolerated at all doses evaluated. No serious or severe adverse events (AEs) occurred, and no trends were identified with regard to frequency or type of AEs with increasing dose. With respect to lung function tests, physical examinations, lung auscultations, clinical laboratory parameters and vital signs, no study drug-related, clinically meaningful findings were observed. Taken together, the results of this study demonstrated the feasibility of delivering Nanobodies by inhalation, a convenient but rarely explored route of administration for antibody-based therapeutics.