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news.Ablynx has received positive results for its phase I study, that involved first ever inhaled Nanobody, ALX-0171, designed for direct lung delivery using a nebulizer to treat respiratory syncytial virus (RSV) infections.
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The study revealed that the Nanobody’s specific structure, stability and small size made possible the convenient route of administration where antibodies have been unsuccessful.
The double-blind, randomized trial with a single-ascending dose was conducted in healthy 44 adult males to check the safety, tolerability and PK profile of ALX-0171.
Ablynx chairman and CEO Edwin Moses said Ablynx believes it is the first time that an antibody-derived drug delivered through inhalation has completed a Phase I trial with no treatment-emergent immunogenicity.
”This is a major safety breakthrough in the search for potential new treatment options for patients with RSV infections, and furthermore supports the potential pulmonary delivery of Nanobodies in a range of lung-based diseases as well as offering another route for systemic administration,” Moses added.
Moses also confirmed the company’s intention to continue the development of ALX-0171.