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New Nanobody Drug-Inhalation Technology Introduced at Respiratory Conference
The biopharmaceutical company Ablynx has presented an overview of its new nanobody platform and the platform’s application for inhaled biological medication at the Respiratory Drug Delivery (RDD) Europe 2015 Conference, being held in Nice, France.
The presentation focused on the treatment of respiratory syncytial virus (RSV) infection with the inhaled nanobody therapeutic ALX-0171, which is being developed for use in the general pediatric population.
Inhalation allows the delivery of ALX-0171 directly to the site of viral infection (i.e., the respiratory tract, including the lower airways), where it inhibits viral replication and neutralizes viral activity by blocking virus uptake in cells.
In a proof-of-concept study, daily inhalation of ALX-0171 for 3 consecutive days resulted in a marked reduction in the symptoms of illness, viral titers, and RSV-associated lung pathology in neonatal animals with established RSV infection. Clinically, ALX-0171 has been shown to be well tolerated in more than 100 adults, including subjects with sensitive (hyper-reactive) airways.
In December 2014, Ablynx initiated a study to evaluate the safety, tolerability, and clinical activity (including the effect on feeding, respiratory rate, wheezing, coughing, general appearance, and clinical scores) of inhaled ALX-0171 in otherwise healthy infants (aged 3 to 24 months) diagnosed with RSV and hospitalized for a lower respiratory tract infection. The lead-in part of the study with five infants has been successfully completed, and recruitment is now on-going for the placebo-controlled part of the trial, which will include a total of 30 infants. Preparations are currently ongoing to open clinical study centers in the Asia–Pacific region, where the RSV season occurs later than in the northern hemisphere. The company’s goal is to complete recruitment by the end of 2015, with results expected during the first half of 2016.
RSV remains the primary cause of infant hospitalization and of virus-associated deaths in infants. In addition, RSV infections have been linked to an increased risk for the development of asthma later in life. It has been estimated that more than 300,000 children (younger than 5 years of age) are hospitalized each year in the seven major pharmaceutical markets, and that the RSV infection rate is 70% to 80% in children under 2 years of age. In addition, RSV infection is a significant cause of pulmonary disease in transplant patients, in immunocompromised subjects, and in the elderly.